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a b/clusters/3009knumclusters/clust_167.txt
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All patients and/or their parents or legal guardians must sign a written informed consent
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Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
3
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
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All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
5
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
6
Subject has given written informed consent
7
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
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All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
9
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
10
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
11
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
12
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
13
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
14
Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines; for step 1 initial registration, the appropriate consent form is the step 1 consent form
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Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; the appropriate consent form for this registration is the step 2 consent form
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STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; the appropriate consent form for this registration is the step 2 consent form
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Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
18
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
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Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
20
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
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REGISTRATION STEP 2-RANDOMIZATION: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
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Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines
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Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
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Patient must have given written informed consent
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All patients and/or their parents or legal guardians must sign a written informed consent
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All patients and/or their parents or legal guardians must sign a written informed consent.
27
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
28
All patients and/or their parents or legal guardians must sign a written informed consent
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Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
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All patients and/or their parents or legal guardians must sign a written informed consent
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All patients and/or their parents or legal guardians must sign a written informed consent
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All patients and/or their parents or legal guardians must sign a written informed consent
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All patients and/or their parent or legal guardian must sign a written informed consent
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All patients and/or their parents or legal guardians must sign a written informed consent
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Each patient’s parents or legal guardians must sign a written informed consent
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All patients and/or their parents or legal guardians must sign a written informed consent
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Written informed consent
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All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
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Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
40
All patients and/or their parents or legal guardians must sign a written informed consent
41
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
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Patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
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ALL PATIENTS: Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
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All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
45
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
46
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
47
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
48
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
49
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
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All patients and/or their parents or legal guardians must sign a written informed consent
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Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
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Voluntary written informed consent
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Patients with mental deficits or psychiatric conditions that preclude them from giving informed consent or following protocol
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Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.
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Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; NOTE: HIPAA authorization may be either included in the informed consent or obtained separately; consent and HIPPA authorization must be obtained prior to any screening procedures
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Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
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Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements
58
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
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Written informed consent which is consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation.
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Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
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Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
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The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
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All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must have signed an authorization for the release of their protected health information
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All patients and/or their parents or legal guardians must sign a written informed consent
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Informed consent must be obtained according to St. Jude guidelines before enrollment into study
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Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
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Signed and dated voluntary written informed consent before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
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Any HSCT within 6 months prior to signing informed consent
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Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH GCP Guidelines and applicable local regulations.
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At least 18 or older of age on day of signing informed consent
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Documented informed consent
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Voluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
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Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
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Patients must give informed consent prior to initiation of therapy
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Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
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Subject must have a brain scan performed during Screening or within 3 months prior to signing informed consent;
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Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
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Any perceived inability to directly (and without the means of a legal guardian) provide informed consent
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SAFETY RUN-IN: Signed written informed consent in accordance with regulatory and institutional guidelines
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RANDOMIZED PHASE II CLINICAL TRIAL: Signed written informed consent in accordance with regulatory and institutional guidelines
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Potential subject must have the ability to understand (as judged by the treating physician) and willingness to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separately; written informed consent must be obtained from a potential subject prior to the conduct of any study-specific procedures
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Patients have voluntarily agreed to participate by giving written informed consent.
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Voluntary written informed consent
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Informed consent/assent
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Execute an informed consent.
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Voluntary written consent must be signed before performance of any study related procedure not part of standard medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care
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Subjects unable to comprehend and give informed consent are excluded.
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Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care
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Written and voluntary informed consent.
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Written informed consent
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Voluntary written informed consent before performance of any study-related procedure not part of routine medical care with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
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Written informed consent
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Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent; in patients who are not able to consent to the trial due to medical circumstances, the next of kin or power of attorney may consent for the study
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Provided informed consent
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Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
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Written informed consent in accordance with federal, local, and institutional guidelines
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Written informed consent in accordance with federal, local, and institutional guidelines
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Patients must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects; patients will be given a copy of the consent form
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Patients must agree, as part of the informed consent, to provide blood for pharmacokinetics analysis
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The subject or subject's medical power of attorney has provided written consent to participate in this study.
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Ability to give informed consent.
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Have mental deficits and/or psychiatric history that may compromise the ability to give written informed consent or to comply with the study protocol.
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Subject is ? 18 years of age at the time of signing the informed consent form (ICF).
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Be capable, willing, and able to provide written informed consent/assent. For patients < 18 years of age, their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
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A patient must be capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject’s behalf
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Legal incapacity/limited legal capacity for providing informed consent.
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Ability to understand the nature of this study and give written informed consent.
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Ability to give informed consent; all subjects >= 18 years of age must be able to give informed consent; for subjects < 18 years old their legal authorized representative (LAR) (i.e. parent or guardian) must give informed consent; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those > 7 years of age, when appropriate
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Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
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Ability to understand and the willingness to sign an informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
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Informed consent cannot be obtained either from the patient or legal representative
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Documented informed consent of participant and/or legally authorized representative
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Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
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Written informed consent has been obtained
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Informed and must sign and give written informed consent in accordance with institutional and federal guidelines
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Provided written informed consent and HIPAA authorization for release of personal health information, approved by an Institutional Review Board (IRB). NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
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Any mental or medical condition that prevents the subject from giving informed consent or participating in the trial.
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Patients must have the psychological ability and general health that permits informed consent, completion of the study requirements, and required follow up
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All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
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All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
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Written informed consent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office for Human Research Protections (OHRP) guidelines
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Inability or unwillingness of legal guardian/representative to give written informed consent
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All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
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Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
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Provision of informed consent
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Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
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For inclusion in optional genetic research, the patient must provide a written informed consent for genetic research.
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Written informed consent prior to any procedure.
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Patient must sign an informed consent document indicating that they are aware of the investigational nature of this study, which includes an authorization for the release of their protected health information
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Patient and/or legal guardian must sign informed consent for HSCT.
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Ability to understand and the willingness to sign a written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
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Patients with mental deficits and/or psychiatric history that preclude them from giving informed consent or from following protocol
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Subjects or their legally authorized representative must be informed of the investigational nature of this study, and must sign and give written informed consent in accordance with institutional and federal guidelines
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Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
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The patient has given written informed consent after the nature of the study and alternative treatment options have been explained
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Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
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Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.
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Informed consent provided
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Provides written informed consent on the approved informed consent form
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Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
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Patient or parent/guardian capable of providing informed consent
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Patient or parent/guardian capable of providing informed consent
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All subjects must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
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Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients, which can be accomplished using the NCI, POB screening protocol; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for screening or baseline values even if the studies were done before informed consent was obtained, if the patient agrees
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Paediatric patients aged 2 years to <18 years at the time of informed consent
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Patients, parents/guardian(s), legally authorized representative (LAR), or durable power of attorney must be able to give consent and sign the informed consent document; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those > 7 years of age, when appropriate
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Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
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Patients must give voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization before performance of any study-related procedure not part of normal medical care with the understanding that consent maybe withdrawn by the subject at any time without prejudice to future medical care
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ELIGIBILITY FOR SCREENING: Informed consent (and assent as applicable) obtained from patient/guardian
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Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
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Voluntary written consent must be given before performance of any study-related procedures not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
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No written consent of the patient or his/her parents or legal guardian
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Informed consent must be obtained from all patients prior to beginning therapy, including consent for mandatory tissue submission for ERCC1 staining (and p16 staining if not locally conducted); patients should have the ability to understand and the willingness to sign a written informed consent document
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Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects; patients or their guardians will be given a copy of the consent form
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All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
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Voluntary written informed consent before performance of any study-related procedure not part of normal medical care
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Written informed consent provided.
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All participants and/or their parents or legal guardians must sign a written informed consent
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Unwillingness to give written informed consent
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Patient must be at least 18 years old at the time of consent.
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Must be capable of giving consent to participate in the study
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Patients who give a written informed consent obtained according to local guidelines
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Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
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Provided written informed consent
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Has provided written informed consent for participation in this trial
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Cognitively impaired patients who cannot give informed consent and do not have a legal guardian
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Subject has provided written informed consent
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Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
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The patient or their legal guardian must give their informed consent
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Willing to give informed consent\r\n* A parent or guardian must be available for giving consent for pediatric subjects under 18 years of age
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Ability to understand and the willingness to sign a written informed consent document. Patients with Impaired Decision Making Capacity (IDMC) can have a Legally Authorized Representative sign on their behalf. Documentation, such as a Power of Attorney, must be presented in order for a substitute decision maker to be allowed
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Willing and able to provide written informed consent (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
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Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information. Consent for the use of any residual material from biopsy (archival tissue) and serial blood draws will be required for enrollment.
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Inability or unwillingness or research participant or legal guardian/representative to give written informed consent
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Ability to give written informed consent
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Have the capacity to give informed consent
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All subjects must have the ability to understand and the willingness to sign a written informed consent; they are to give voluntary written informed consent before performance if any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care; cognitively impaired subjects will be included only if their guardian or legal representative agrees to sign the written informed consent
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Signed written informed consent: voluntary written consent must be given before performance of any study-related procedure not part of standard medical care
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Subjects given written informed consent
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Give informed consent
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Refuses to give informed consent
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Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the Unites States of America [USA] only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.
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Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately
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Subjects must be willing and able to provide informed consent. For patients < 18 years of age, their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
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Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
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Ability of subject or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document; for subjects < 18 years old their legal guardian must give informed consent; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those > 7 years of age, when appropriate
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Has any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
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Voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
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Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
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Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
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Unable to give informed consent
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For inclusion in the optional PGx research, patients must provide informed consent for the genetic sampling and analyses.
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Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
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Men and women ?18 years old on the day of signing informed consent.
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Written informed consent and authorization for release of personal health information obtained according to local laws.
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Provision of written informed consent
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Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization. This will be assessed by the consenting physician using general questions as outlined in Etchell’s 1999 publication titled Assessment of Patient Capacity to Consent to Treatment. These are general conversation based questions that assess the patient’s ability to understand the medical problem, proposed treatment, alternatives to proposed treatment, and understand the consequences of the medical choices
198
The subject (or legally acceptable representative if applicable) provides written informed consent for the trial. The subject may also provide consent for future biomedical research. However the subject may participate in the main trial without participating in future biomedical research.
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Signed and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation.
200
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
201
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
202
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
203
Ability to understand the nature of this trial and give written informed consent.
204
All patients >= 18 years of age must sign a written informed consent; for patients < 18 years old, the patient’s parents or legal guardians must sign a written informed consent, unless the patient is an emancipated minor; childhood assent, when age appropriate as per institutional guidelines, should be signed by the participating patient
205
Informed consent for participation
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Written informed consent must be obtained from the patient.
207
Documented informed consent of participant and/or legally authorized representative
208
Written informed consent.
209
All patients and/or a legal guardian must sign institutionally approved written informed consent and assent documents
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Written informed consent and authorization obtained from the subject/Health Insurance Portability and Accountability Act (HIPAA)-appointed legal representative prior to performing any protocol-related procedures including screening evaluations
211
Patient has a psychiatric illness that would prevent the patient or legal guardian or representative from giving informed consent and/or assent.
212
Have the capacity to give informed consent
213
Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
214
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
215
Patients and/or their parents or legal guardians must be capable of understanding the investigational nature, potential risks and benefits of the study; all patients and/or their parents or legal guardians must sign a written informed consent
216
Have provided written informed consent
217
Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
218
Has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process
219
Patients must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
220
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
221
Patients must be capable of understanding and providing a written informed consent
222
Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy.
223
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
224
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
225
Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures
226
Informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information obtained
227
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
228
Voluntary written consent signed before performance of any study-related procedure not part of normal medical care
229
Subject is 1 to < 21 years of age at the time of signing the Informed Consent Form/Informed Assent Form (ICF/IAF).
230
Subjects must be informed of the investigational nature of this study, and must sign and give written informed consent in accordance with institutional and federal guidelines.
231
At least 18 years old at the time of informed consent
232
All participants and/or their parents or guardians must sign a written informed consent.
233
Must have provided written informed consent prior to participating in any study-related activity.
234
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
235
Written informed consent in accordance with federal, local, and institutional guidelines
236
All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
237
Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy
238
Subjects must give informed consent according to the rules and regulations of the individual participating sites.
239
Written informed consent.
240
Understand and able to willingly provide voluntary written informed consent, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
241
Patient is ? 18 years old at the time of informed consent.
242
Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
243
Written informed consent
244
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information
245
Have provided written consent for protocol directed biopsies
246
Signed and dated written informed consent must be provided by the patient prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation
247
Patients or appropriate legally authorized representatives must possess the ability to give informed consent
248
Documented informed consent of the participant or legally authorized representative
249
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
250
Inability to understand or give an informed consent
251
Voluntary written consent
252
DONOR: Documented informed consent per local, state and federal guidelines
253
Written, informed consent and assent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office for Human Research Protections (OHRP) guidelines
254
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
255
Patients must be informed of investigational nature of this study and must be willing to give written informed consent in accordance with institutional and federal guidelines. Patients must be able to comply with the requirements and assessments of the study protocol
256
Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure. However, the Investigator should not repeat procedures that are performed as part of standard of care (SOC), if they are within the screening window and are done prior to signing the informed consent form (ICF)
257
Voluntary signed informed consent before performance of any study related procedure not part of normal medical care indicating that the patient is aware of the investigation and nature of this study in keeping with institutional policies and with the understanding that the consent may be withdrawn with the subject at any time without prejudice to future medical care
258
Written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
259
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of protected health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
260
The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
261
Have provided written informed consent.
262
Ability to give informed consent
263
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; provision of informed consent prior to any study procedures\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
264
Signing of the Informed Consent Form
265
Psychiatric disorder that would preclude patients from signing an informed consent
266
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
267
PRE-SCREENING: Written informed consent for prescreening
268
FULL STUDY INCLUSION CRITERIA: Written informed consent for full study
269
Ability to give informed consent and comply with the protocol
270
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information. Patients must be registered prior to treatment on study.
271
Provision of genetics research informed consent
272
All patients must be capable to voluntarily sign an informed consent indicating that they are aware of the investigational nature of this study prior to registration
273
Voluntary written consent
274
Patient, or patient's authorized representative, must be willing and capable of giving written Informed Consent and must be able to adhere to dosing and visit schedules as well as meet all study requirements
275
Inability to give voluntary informed consent
276
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
277
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the subject/legal representative prior to performing any protocol-related procedures
278
Provide informed consent for genetic sampling and analyses
279
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
280
All participants will undergo standard written informed consent procedures as dictated by the City of Hope Human Research Protections Office prior to performing any screening procedures that are not part of standard-of-care; informed consent will be obtained by the principal investigator, collaborating investigators, or other Institutional Review Board (IRB) designated personnel who will meet the training requirements established by the IRB; with the support of research personnel, he/she will explain the nature, duration, purpose of the study, potential risks, alternatives and potential benefits, and all other information contained in the informed consent document; in addition, they will review the experimental subject's bill of rights and the Health Insurance Portability and Accountability Act (HIPAA) research authorization form; prospective research participants will be informed that they may withdraw from the study at any time and for any reason without prejudice; prospective research participants will be afforded sufficient time to consider whether or not to participate in the research
281
CELL PROCUREMENT: Written informed consent for procurement signed by subject or legal guardian of a pediatric subject and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
282
LYMPHODEPLETION: Written informed consent for the main study signed by subject or legal guardian of a pediatric subject
283
Voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
284
Documented informed consent of the participant and/or legally authorized representative
285
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
286
Documented informed consent of the subject and/or legally authorized representative
287
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
288
Ability to understand and the willingness to sign a written informed consent that is consistent with International Conference on Harmonization (ICH)-Good Clinical Practice (GCP) guidelines
289
Voluntary written informed consent
290
Subject or subject's legally acceptable representative has provided informed consent.
291
Written informed consent obtained prior to biopsies and blood samples
292
Written informed consent obtained prior to biopsies and blood samples
293
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
294
Patients must understand and sign informed consent that explains the neoplastic nature of their disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, potential risks and toxicities, and the voluntary nature of participation
295
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care. Participants should consent and enter the study within a maximum of 8 weeks of their last dose of ixazomib in the parent study or as agreed by the Millennium clinician/designee.
296
Willingness to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)
297
Provision of written informed consent to participate in this investigational study
298
Subjects must have the ability to understand and the willingness to sign a written informed consent document and Health Insurance Portability and Accountability Act (HIPAA) consent document; voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
299
Written informed consent must be obtained prior to enrolling in the rollover study and receiving the study treatment. If consent cannot be expressed in writing, then the consent must be formally documented and witnessed, ideally via an independent trusted witness
300
Must be capable of providing informed consent
301
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate will be obtained according to institutional guidelines
302
Inability to give informed consent
303
Patients who give a written informed consent obtained according to local guidelines
304
Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients, which can be accomplished using the study specific informed consent or another consent, such as the National Cancer Institute (NCI), Pediatric Oncology Branch (POB) screening protocol; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for screening or baseline values even if the studies were done before informed consent was obtained, if the patient agrees
305
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
306
Patient and/or legal guardian must sign informed consent for BMT
307
The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
308
All patients must have provided informed consent for correlative studies
309
Written informed consent obtained prior to any study-related procedure being performed.
310
Signed written informed consent including Health Insurance Portability and Accountability Act (HIPAA) according to institutional guidelines
311
Legal guardians must sign an informed consent indicating that they are aware of this study, the possible benefits, and toxic side effects; legal guardians will be given a signed copy of the consent form
312
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
313
Patients must give documented informed consent to participate in this study
314
Subject/parental/guardian permission (informed consent), and child assent for subjects >= 7 years
315
PART 2 GROUP 1 INCLUSION CRITERIA: All subjects or a parent/guardian must sign written informed consent
316
PART 2 GROUP 2A INCLUSION CRITERIA: All subjects or a parent/guardian must sign written informed consent
317
PART 2 GROUP 3 INCLUSION CRITERIA: All subjects or a parent/guardian must sign written informed consent
318
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
319
Patients or parents/legal guardian must be able to give informed consent
320
mCRPC EXPANSION COHORT: Patient must be capable of understanding and complying with protocol requirements and is willing to give informed consent
321
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separately
322
Written informed consent
323
Written informed consent for transplant
324
Unable to give informed consent
325
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
326
All subjects must have the ability to understand and the willingness to sign a written informed consent; they are to give voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
327
Any psychiatric disorder that prohibits obtaining informed consent
328
Informed consent
329
Patients or their legally authorized representative must have the ability to understand and provide signed informed written consent
330
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
331
The subject must be deemed competent to give informed consent
332
The subject is cognitively impaired, and unable to give informed consent
333
ability to consent
334
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
335
Patient must willingly provide written consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
336
PRIOR TO CELL PROCUREMENT: Informed consent explained to, understood by and signed by the patient or legal guardian for pediatric patients; patient and/or legal guardian given a copy of informed consent form for procurement
337
PRIOR TO LYMPHODEPLETION: Informed consent explained to, understood by and signed by the patient or legal guardian for pediatric patients; patient and/or legal guardian given a copy of informed consent form
338
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital
339
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
340
Has given written consent to participate in the study.
341
Voluntary written consent before any research related procedures or therapy
342
Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
343
Subject has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
344
Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital
345
Voluntary written consent
346
Patients unable to comprehend and give informed consent are excluded
347
Ability for patient (and if applicable parent or legal guardian) to understand and the willingness to sign a written informed consent document, or for a parent or legal guardian to give assent for those cases where a very young patient is unable to understand or sign the consent
348
Gives voluntary informed consent
349
Subject is capable of understanding the informed consent process
350
Written informed consent is given
351
All participants and/or their parents or legally authorized representatives must sign a written informed consent; assent will be obtained for all participants under the age of 18 years
352
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
353
Ability to give informed consent
354
The subject has been fully informed about the study and has signed the informed consent form and, where appropriate, Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separately
355
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
356
Patient has given written informed consent.
357
Unwilling or inability to give informed consent
358
Inability to obtain informed consent from patient or surrogate
359
Patients must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
360
Informed consent
361
Written and voluntary informed consent
362
Patients must sign an informed consent and authorization indicating that they are aware of the investigational nature of this study and the known risks involved
363
Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
364
Have signed an informed consent indicating that the patient is aware of the neoplastic nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, possible alternative therapies, potential benefits, side effects, risks, and discomforts
365
Written informed consent
366
Written informed consent from patient or legal representative
367
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
368
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration; NOTE: HIPAA authorization may be included in the informed consent or obtained separately; subject must have the ability to understand and willingness to sign the written informed consent document
369
Sign Subject Information Sheet and Informed Consent Form
370
Capable of understanding and complying with the protocol requirements and has signed the informed consent document; voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
371
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
372
Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
373
Patient, or the patient’s legal representative, has voluntarily agreed to participate by giving written informed consent
374
DONOR: Written informed consent
375
Patients must have the ability to give informed consent
376
Patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
377
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines; patient must sign an informed consent document indicating that they understand the purpose of and procedures required for the study, and are willing to participate in and comply with the guidelines of the study
378
Inability to understand or give an informed consent
379
All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines; a copy of the informed consent document signed by the patient must be given to the patient
380
Cognitive impairment that precludes a patient from acting as his or her own agent to provide informed consent
381
Subjects unable to give informed consent
382
Subject has provided informed consent
383
Have the ability to understand, and have given written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
384
All patients must be informed of the investigational nature of this study and must sign and\\ give written informed consent in accordance with institutional and federal guidelines
385
Written and signed informed consent from the parent(s) or legal representative (guardian) and assent from the minor participant. Written informed consent from subjects ?18 years.
386
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
387
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
388
Ability to give written informed consent
389
Patient understands the nature of the procedure, is willing to comply with associated follow–up evaluations, and provide written informed consent prior to the procedure
390
Age ? 18 years with the capacity to give written informed consent
391
Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary
392
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent will be obtained, when appropriate, according to institutional guidelines
393
All subjects and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
394
Ability to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
395
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
396
A written informed consent MUST be obtained from the patients and/or their parents/legal guardians prior to enrollment indicating their awareness of investigational nature of this study
397
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
398
Ability to give informed consent
399
Subjects must be willing and able to provide written informed consent for the trial and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of protected health information\r\n* NOTE: HIPPA authorization may be included in the informed consent or obtained separately
400
Voluntary written consent with appropriate parent/guardian consent and minor information sheet for participants < 18 years of age
401
Unable to give informed consent
402
Has any mental or medical condition that prevents the patient from giving informed consent
403
All patients and/or their parents or legally authorized representatives must sign a written informed consent.
404
Ability to consent to treatment - patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
405
Any perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian)
406
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
407
All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
408
Patients must give informed consent
409
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
410
Subjects must give written informed consent to participate in this trial
411
Patient and/or parents or authorized legal representative have signed a written informed consent/assent per institutional guidelines
412
Patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
413
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
414
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
415
Written informed consent in accordance with federal, local, and institutional guidelines
416
Written informed consent obtained
417
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
418
Ability to understand and the willingness to sign a written informed consent document and consent to the serial nature of the proposed Personalized ANtibodies for Gastro-Esophageal Adenocarcinoma (PANGEA) treatment with first, second and third line therapy as tolerated
419
Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution; patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy
420
Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits
421
Provision of written informed consent
422
Consent: all patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
423
All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
424
Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits
425
All research participants must have the ability to understand and willingness to sign a written informed consent or age appropriate assent for pediatric patients\r\n* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
426
All subjects must have the ability to understand and the willingness to sign a written informed consent\r\n* Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
427
All research participants must have the ability to understand and the willingness to sign a written informed consent\r\n* Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent in processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
428
Voluntary written consent signed before performance of any study-related procedure not part of normal medical care
429
Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.
430
Inability to give informed consent or lacks decision making capacity
431
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
432
Willing to sign an informed consent form, indicating awareness of the investigational nature of this study that is in keeping with the policies of the institution.
433
Written voluntary informed consent
434
Patient has voluntarily agreed to participate by giving written informed consent/assent for the trial
435
Patients must have the ability to give informed consent
436
Participant has the ability and the willingness to sign the informed consent document (for adults only, for participants with mild cognitive abilities may use a legally authorized representative)
437
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care
438
Patient or patient’s legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant’s age is at least seven and less than eighteen years
439
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
440
Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
441
Patients must have the ability to understand the study, its risks, side effects, potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
442
The recipient and/or the recipient's legal guardian must have been informed of the investigational nature of this study and have signed a consent form which is in accordance with Federal guidelines
443
Capable of providing informed consent
444
Ability to comprehend and willing to sign an informed consent, assent obtained from minors
445
Patients must be aware of the investigational nature of the therapy and provide written informed consent
446
Written informed consent is given
447
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study
448
Patient capable of giving informed consent
449
Written informed consent in accordance with federal, local, and institutional guidelines
450
Written informed consent in accordance with federal, local, and institutional guidelines
451
Written voluntary informed consent
452
Clinical performance status of ECOG 0-2 within 30 days of signing informed consent (Turnstile II)
453
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
454
Patient capable of giving informed consent
455
Patient or patient’s legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant’s age is at least seven and less than eighteen years
456
RECIPIENT: Ability of subject or legally authorized representative (LAR) (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of this study or written informed consent obtained from parent or legal guardian if subject is a minor
457
Written, informed consent according to institutional guidelines
458
Subjects given written informed consent
459
Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects; patients or their guardians will be given a copy of the consent form
460
Voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
461
Capable of informed consent
462
Written informed consent obtained prior to enrolling in roll-over study and receiving study medication • If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness
463
Legal guardians must sign an informed consent indicating that they are aware of this study, the possible benefits, and toxic side effects; legal guardians will be given a signed copy of the consent form; note: for inclusion on biology studies after enucleation, the patient or his/her legal guardian, as appropriate, must provide written informed consent for SJRET6 protocol within 60 days of the removal of the tissue (eye) sample
464
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
465
Written informed consent in accordance with federal, local, and institutional guidelines
466
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
467
Ability to give informed consent
468
Patient has voluntarily agreed to participate by giving written informed consent
469
Patients must be aware of the investigational nature of the therapy and provide written informed consent
470
Patients must be able to give informed consent; parent or legal representative will be asked to consent for patients younger than 18 year old
471
Patients must give documented informed consent to participate in this study
472
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of MD Anderson Cancer Center (MDACC)
473
All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
474
Patient should be able to provide signed written informed consent; before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel; written consent will include a Health Insurance Portability and Accountability Act (HIPAA) form according to institutional guidelines
475
There will be no upper age limit for eligibility; elderly patients will be eligible for participation provided they are competent to provide informed consent, or written consent can be provided by their duly appointed healthcare proxy
476
Patients must voluntarily sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
477
Patients unable to give informed consent for the study will be excluded
478
Capability of providing informed consent
479
Inability to grant informed consent
480
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must have signed an authorization for the release of their protected health information at all sites except the National Institutes of Health (NIH)
481
Inability to understand or give an informed consent
482
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; Note: HIPAA authorization may be included in the informed consent or obtained separately
483
Have mental deficits and/or psychiatric history that may compromise the ability to give written informed consent or to comply with the study protocol.
484
All patients must have a surgical and medical oncology consult prior to signing informed consent
485
Inability to obtain informed consent
486
Ability to understand and the willingness to sign a written informed consent document; the patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
487
Provision of written informed consent
488
Written voluntary informed consent
489
Psychiatric disorder that would preclude patients from signing an informed consent
490
All patients and/or their parents or legal guardians must sign a written informed consent
491
Subjects given written informed consent
492
Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects; patients or their guardians will be given a copy of the consent form
493
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.
494
Patients, parents/guardian(s), legally authorized representatives (LAR), or durable power of attorney must be able to give consent and sign the informed consent document; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those > 12 years of age, when appropriate
495
Recipient must have signed a voluntary, informed consent in accordance with institutional and federal guidelines
496
Informed consent
497
Have provided informed consent
498
Ability to give informed consent
499
Written voluntary informed consent
500
Must have the capacity to give informed consent
501
Written informed consent by patients and/or their parents or legal guardians; assent for those patients inclusive of ages 12 to 17
502
Patients with psychiatric or addictive disorders that would preclude obtaining informed consent
503
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
504
Inability to give informed consent or assent
505
Patients must be capable of informed consent
506
The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained in accordance with the institutional policies approved by the United States (U.S.) Department of Health and Human Services; informed consent must be signed prior to registration on study
507
Recipients will sign informed consent approved by the Committee on the Use of Human Subjects at the University of Minnesota
508
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
509
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
510
Psychological condition that renders the patient unable to understand the informed consent
511
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
512
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care
513
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care
514
Subjects must sign a written informed consent in accordance with institutional guidelines
515
Patients must demonstrate the ability and willingness to give informed consent.
516
Subject (or legal guardian) must sign a written informed consent in accordance with institutional guidelines
517
Informed consent must be obtained
518
Ability to give informed consent
519
Signed informed consent form by patients and/or patients' parents/legal guardians and age appropriate assent form by the patients obtained before any study specific procedure
520
Subject must be >=18 years of at the time of signing the informed consent.
521
Informed consent: All participants and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines. Participants must be willing to comply with all aspects of the protocol.
522
Informed Consent
523
Written informed consent obtained prior to any study-related procedure being performed;
524
Voluntary written consent (adult or legally authorized representative; or parental/guardian)
525
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
526
Written informed consent for the trial
527
Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out.
528
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separately
529
Provision of informed consent prior
530
Patients must give informed consent
531
Voluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
532
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
533
Subject is ? 18 years of age at the time of signing the informed consent form (ICF)
534
Written informed consent prior to admission to this study
535
Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed via an independent trusted witness.
536
Patients must consent to be in the study and sign an approved consent form conforming with institutional guidelines
537
Written informed consent in accordance with federal, local, and institutional guidelines
538
Written informed consent that is consistent with International Conference on Harmonisation Tripartite Guideline on Good Clinical Practice guidelines
539
Patients must give written informed consent prior to registration on the study
540
Inability to give informed consent
541
Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
542
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; note: HIPAA authorization may be included in the informed consent or obtained separately
543
Informed consent
544
Cognitive impairment such as to preclude informed consent
545
Patients must be capable of understanding of the nature of their disease and willingly give consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts
546
Patients, or legal guardians, and donors must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects
547
Written informed consent
548
Written informed consent
549
Unwillingness or inability to given written informed consent.
550
Cases involving subjects who are minors, pregnant or require an authorized representative for informed consent
551
Subjects who are ?18 years of age on the date of written informed consent.
552
Subjects who have voluntarily agreed to participate by giving written informed consent.
553
All patients and/or their parents or legal guardians must sign a written informed consent
554
102 Age ? 18 at the time of informed consent.
555
Written informed consent and authorization for release of personal health information obtained according to local laws.
556
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separately
557
Adults capable of giving informed consent.
558
Documented informed consent of the participant and/or the legally authorized representative
559
Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
560
Ability to understand and the willingness to sign a written protocol specific informed consent for tissue harvest or a parental/guardian informed consent and pediatric assent when appropriate.
561
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
562
Voluntary written consent
563
Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
564
Written informed consent in accordance with institutional guidelines.
565
Patient is capable of giving informed consent
566
Voluntary written consent
567
Documented informed consent of the participant and/or legally authorized representative
568
Voluntary written consent (adult or parental/guardian)
569
DONORS: Voluntary written consent prior to the performance of any research related procedure
570
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
571
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
572
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
573
Written informed consent
574
Ability to consent
575
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration for protocol therapy\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separately
576
Ability to give informed consent and comply with the protocol
577
Each patient must be aware of the nature of their disease and must willingly consent to treatment after being informed of alternatives, potential benefits, side effects, and risks
578
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
579
Written informed consent according to institutional guidelines, and
580
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
581
Written informed consent provided
582
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for the release of personal health information \r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
583
Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
584
Subjects or their legal guardian must sign a written informed consent in accordance with institutional guidelines
585
The subject must be deemed competent to give informed consent
586
The subject is unable to give informed consent
587
The subject is cognitively impaired, and unable to give informed consent
588
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
589
All patients or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
590
All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
591
All patients and/or their parents or legal guardians must sign a written informed consent
592
Patient has given voluntary written informed consent before performance of any study-related procedures not part of standard (non-investigational) medical care
593
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
594
Informed consent and assent obtained as appropriate
595
All patients and/or their parents or legal guardians must sign a written informed consent
596
History of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months; any perceived inability to directly provide informed consent (Note: Consent may not be obtained by means of a legal guardian)
597
Patients must give informed consent
598
Voluntary written consent
599
Inability to give voluntary informed consent or obtain a parent or guardian’s informed consent
600
Informed consent
601
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
602
All patients and/or their parents or legal guardians must sign a written informed consent
603
Written informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization for release of personal health information
604
Patients must sign an informed consent document that indicates they are aware of the investigative nature of the treatment in this protocol as well as the potential risks and benefits
605
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
606
Patient (or his or her legally accepted representative) has provided written informed consent to participate in the study
607
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
608
Signed informed consent to participate in the study, including participation in the expansion cohort after safety of enzalutamide and gemcitabine and cisplatin have been established, must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information
609
All patients and/or their parents or legal guardians must sign a written informed consent
610
All patients and/or their parents or legal guardians must sign a written informed consent
611
Not willing to follow protocol requirements or to give informed consent
612
Ability to give written informed consent
613
Any history of HIV-1 associated encephalopathy; dementia of any kind; seizures in the past 12 months; any perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian)
614
All patients and/or their parents or legal guardians must sign a written informed consent
615
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
616
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
617
Signed, written informed consent in accordance with federal, local, and institutional guidelines
618
All patients and/or their parents or legal guardians must sign a written informed consent
619
Written informed consent in accordance with federal, local, and institutional guidelines
620
Any perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian)
621
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines; patients must be willing to comply with all aspects of the protocol
622
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
623
Written informed consent in accordance with federal, local, and institutional guidelines
624
Untreated psychiatric conditions preventing informed consent
625
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
626
Voluntary written informed consent
627
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
628
Capable of giving written informed consent
629
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
630
Able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)
631
Unable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consent
632
DONOR: Donors able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)
633
DONOR: Persons unable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consent
634
Voluntary written consent
635
Informed consent and assent (as applicable) obtained from parent/guardian and child
636
Signed written informed consent; patient must be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
637
Patients unable to comprehend and give informed consent are excluded
638
Ability to understand and willingness to provide informed consent, and the willingness to comply with the requirements of the protocol; informed consent may be obtained with the assistance of a medical translator according to institutional policies
639
Inability to understand or give an informed consent
640
Patients unable to comprehend and give informed consent are excluded
641
Subjects must be willing to give written informed consent per institutional guidelines and must be able to adhere to dose and visit schedules
642
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
643
Ability to give informed consent; for subjects < 18 years old their legal guardian must give informed consent; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those >= 12 years of age, when appropriate
644
Voluntary written consent
645
Inability to understand the investigational nature of the study to provide informed consent
646
Ability and willingness to participate in the informed consent process and including signing a copy of the informed consent form
647
Patient’s written informed consent
648
Must sign informed consent, witnessed, and dated prior to entry
649
Ability to give informed consent; for patients < 18 years of age their legal guardian must give informed consent; pediatric patients will be included in age-appropriate discussion in order to obtain verbal assent\r\n* Durable power of attorney form completed (patients >= 18 years of age only)\r\n* Female patients (and when relevant their male partners) must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential
650
Patients must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rules
651
Inability to obtain informed consent because of psychiatric or complicating medical problems
652
Subject must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
653
Subject must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
654
Ability to give voluntary informed consent and to comply with treatment and required tests
655
All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
656
Ability to give written informed consent and willingness to comply with the requirements of the protocol
657
Patients must give documented informed consent to participate in this study
658
Inability to understand or give an informed consent
659
Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional standards and federal guidelines
660
Patients must be informed of the investigative nature of the treatment, must give appropriate informed consent to protocol procedures and must sign an Informed Consent documentation form
661
Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects; patients or their guardians will be given a copy of the consent form
662
Informed consent must be obtained from all subjects prior to beginning therapy
663
All participating patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota Committee on the Use of Human Subjects in Research
664
Ability to understand and the willingness to sign a written informed consent document; voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care
665
Inability to give informed written consent
666
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
667
Unable to give informed consent
668
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for all patients the appropriate consent form for this registration is the Step 2 Consent
669
Inability to give informed written consent
670
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\r\n* Voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
671
Aged ?18 years at signing of informed consent.
672
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent prior to any study-related procedures in accordance with institutional and federal guidelines
673
Male or female is 1 to ? 18 years of age at the time of signing the Informed Consent Form / Informed Assent Form (ICF/IAF).
674
Venous thromboembolism within 6 months prior to signing Informed Consent Form.
675
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
676
Lack of parents'/guardian's informed consent for children who are minors.
677
Patients must be able to provide voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
678
Written informed consent
679
Written informed consent and/or assent from patient, parent or guardian.
680
Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines
681
Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
682
REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
683
Subject is male or female, ? 18 years old at the time of signing the informed consent form (ICF).
684
Aged ?18 years at signing of informed consent
685
Written informed consent
686
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
687
Participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document
688
Patients must have the ability to understand and sign an approved informed consent and authorization permitting release of personal health information
689
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
690
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
691
Subject is ? 18 years of age at the time of signing the informed consent form (ICF)
692
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
693
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
694
Able and willing to give voluntary, written and signed informed consent before any screening procedure and according to local guidelines
695
Ability to read and understand the informed consent form and willingness and ability to give informed consent and demonstrate comprehension of the trial before undergoing any trial activities
696
Mentally incompetent or unable or not willing to give written informed consent or meet study requirements
697
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
698
Written Informed Consent
699
Subject is considered an adult according to local regulation at the time of signing informed consent.
700
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
701
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. If the subject is less than 18 years old, an Assent form and parental/guardian Consent form (replacing \you will\ with \your child will\ will be required).
702
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
703
Matched Related Donor: Capable of giving written, informed consent
704
Age ? 18 at time of informed consent
705
Patients must sign a written informed consent prior to entering the study.
706
Written informed consent for the transplant phase
707
Subject has voluntarily agreed to participate by giving written informed consent
708
Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements
709
have undergone ASCT within the period ? 3 months prior to signing the informed consent form.
710
Subjects must be ?18 years of age at the time of signing the Informed Consent Form (ICF);
711
Written informed consent to participate in this study before the performance of any study-related procedure
712
Written informed consent
713
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
714
Written, informed consent and assent following guidelines of the Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP)
715
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
716
All patients must be informed of the investigative nature of the clinical trial and give written informed consent in accordance with institutional and federal guidelines
717
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
718
All patients and/or their parents or legal guardians must sign a written informed consent
719
Subject must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained; and
720
Voluntary written consent given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
721
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
722
Informed Consent Signed informed consent according to institutional guidelines must be obtained. Assent, when appropriate, will be obtained according to institutional guidelines.
723
All subjects or their legally authorized representative must be informed of the investigational nature of the study and provide written informed consent and HIPAA authorization for release of personal health information before performance of any study related procedure not part of routine medical care. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
724
Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements
725
Patient is an adult male/female ? 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines. Female patients must be postmenopausal.
726
Patient must give written informed consent
727
Subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them
728
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
729
Written informed consent is given
730
Obtained written informed consent
731
Written informed consent must be obtained before any assessment is performed.
732
Able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
733
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for all patients, the appropriate consent form for this registration is the Step 2 Consent Form
734
Diagnosis of psychiatric or addictive disorders that would preclude obtaining informed consent
735
Written informed consent to participate in this study
736
Subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them
737
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
738
Provided written consent
739
Inability to understand or give an informed consent
740
Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of University of Texas M.D. Anderson Cancer Center (UTMDACC)
741
Patient must give written informed consent
742
Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
743
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
744
Patient must be capable of understanding and complying with protocol requirements and is willing to give informed consent
745
Informed consent
746
Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects; patients or their guardians will be given a copy of the consent form
747
Written informed consent and HIPAA authorization for release of personal health information.
748
All patients and/or their parents or legal guardians must sign a written informed consent
749
All patients and/or their legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
750
Documented informed consent
751
Written informed consent prior to any procedure
752
Autologous HCT < 3 months prior to the time of signing the informed consent form
753
MDS subjects may not receive RIC and must be < 50 years of age at the time of signing the informed consent form
754
Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
755
Subject is considered an adult according to local regulation at the time of obtaining informed consent.
756
Men and women ? 18 years of age, at the time of signing the informed consent form (ICF).
757
They or their legal guardian must give their informed consent
758
Written, informed consent and assent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office for Human Research Protections (OHRP) Guidelines
759
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
760
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
761
Ability to understand and willingness to sign a written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
762
Capable of giving informed consent
763
Signed and dated written informed consent prior to admission to the study in accordance with international conference on harmonization (ICH)-good clinical practice (GCP) guidelines and to the local legislation
764
Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation;
765
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
766
Patients must understand and willingly sign an approved informed consent, and authorization permitting release of personal health information
767
Ability to give informed consent
768
Written informed consent provided
769
Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information
770
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
771
Written informed consent and authorization obtained from the subject/Health Insurance Portability and Accountability Act (HIPAA)-appointed legal representative prior to performing any protocol-related procedures including screening evaluations
772
Patients must be willing to give written informed consent, and sign an institutionally approved consent form before performance of any study-related procedure not part of normal medical care as noted above; with the exception of 1 cycle of chemotherapy based on current diagnosis and clinical condition, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
773
Subject is ? 18 years of age or is considered an adult according to local regulation at the time of signing informed consent.
774
Capable of giving written informed consent, which includes compliance with the requirements and restrictions
775
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
776
Signed, written informed consent in accordance with federal, local, and institutional guidelines
777
All patients and/or their parents or legal guardians must sign a written informed consent
778
Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
779
Has any mental or medical condition that prevents the subject from giving informed consent or participating in the trial
780
Give informed consent
781
Refuses to give informed consent
782
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
783
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care
784
Patients must sign an informed consent and authorization indicating that they are aware of the investigational nature of this study and the known risks involved
785
Be willing and able to provide written informed consent for the trial and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
786
Subject has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
787
Any mental or medical condition that prevents the subject from giving informed consent or participating in the trial.
788
Written informed consent and HIPAA authorization for release of personal health information
789
Patient and his/her partner agree to use adequate contraception after providing written informed consent through 3 months after the last dose of PBI 05204, as follows:
790
Written informed consent obtained from the patient/legal representative;
791
All patients >= 18 years must sign a written informed consent; patients < 18 years old must provide assent, and the parent or legal guardian must sign the written informed consent
792
Unable to give informed consent
793
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
794
Patient will read, understand and sign the informed consent and Health Insurance Portability and Accountability Act (HIPAA) agreement
795
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent prior to any screening procedures in accordance with institutional and federal guidelines
796
Subjects must give written informed consent to participate in this trial
797
Written informed consent must be obtained
798
Written informed consent
799
Written informed consent obtained from the patient/legal representative
800
Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines to ensure compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations
801
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
802
Written informed consent in accordance with federal, local, and institutional guidelines
803
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
804
Written informed consent in accordance with federal, local, and institutional guidelines
805
The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
806
Patients must understand and sign informed consent that explains the neoplastic nature of their disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, potential risks and toxicities, and the voluntary nature of participation
807
Informed consent must be signed prior to the treatment; patients must willingly consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side effects, risks and\r\ndiscomforts; (human protection committee approval of this protocol and a consent form is required)
808
Ability to understand the nature of this study and give written informed consent.
809
Written informed consent in accordance with federal, local, and institutional guidelines
810
Voluntary written informed consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
811
Written informed consent in accordance with federal, local, and institutional guidelines
812
Inability to give informed consent
813
Written informed consent, Release of Medical Records Form and HIPAA reviewed and signed by patient or legally authorized representatives
814
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
815
Patients must have the ability to understand the study, its risks, side effects, potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
816
Written informed consent in accordance with federal, local, and institutional guidelines
817
Ability to understand and voluntarily give informed consent
818
All patients and/or a legal guardian must sign institutionally approved written informed consent document
819
Written informed consent
820
? 18 years at time of consent.
821
Psychiatric disorder that would preclude patients from signing an informed consent
822
Ability to understand and the willingness to sign a written informed consent document; voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care
823
The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
824
Written, voluntary informed consent.
825
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
826
Written informed consent and HIPAA authorization for release of personal health information. HIPAA authorization may be included in the informed consent or may be obtained separately. NOTE: Central pathology review may be conducted any time after definitive surgery. Consenting participants may be pre-registered to the study and proceed with central pathology review before full eligibility has been confirmed. However ALL of the eligibility criteria must be met and formal study registration completed prior to submission of the sample for sequencing.
827
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
828
Written informed consent.
829
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
830
Written informed consent in accordance with federal, local, and institutional guidelines
831
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study
832
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
833
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
834
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
835
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
836
Voluntary written consent
837
Written informed consent must be obtained from all patients before entry into the study
838
All patients must be informed and must sign and give written informed consent in accordance with institutional and federal guidelines; patients who are unable to comply with study and/or follow-up procedures are ineligible
839
Provide written informed consent (Screen 1 and Screen 2)
840
Voluntary written consent
841
Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
842
Written informed consent
843
Signed written informed consent including Health Insurance Portability and Accountability Act (HIPAA) according to institutional guidelines
844
Written informed consent in accordance with federal, local, and institutional guidelines
845
All patients and/or their parents or legal guardians must sign a written informed consent
846
Patients must have the ability to understand the study, its risks, side effects, potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
847
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
848
Willing and able to provide written informed consent and authorization for use and release of health and research study information (Health Insurance Portability and Accountability Act [HIPAA] authorization)\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
849
Gives voluntary informed consent
850
Must be ? 18yrs at the time of signing informed consent.
851
Signed and dated written informed consent by start date of Screening visit in accordance with Good Clinical Practice (GCP) and local legislation.
852
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
853
All patients must be informed of the investigational nature of this study and must sign and give written consent in accordance with institutional and federal guidelines
854
Voluntary written consent
855
Ability to understand and voluntarily give informed consent
856
Patient must be capable of understanding and complying with protocol requirements and is willing to give informed consent
857
Patients must give voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
858
Patient (or parents/guardians, in the case of minors) must sign an informed consent document indicating that they are aware of the investigational nature of this study, which includes an authorization for the release of their protected health information
859
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
860
Informed consent
861
All patients must sign a consent form indicating that they are aware of the investigational nature of the study; the informed consent form will indicate that the patient has been made aware of all other appropriate therapies
862
Patient should be able to provide signed written informed consent:\r\n* Before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel\r\n* Written consent will include a Health Insurance Portability and Accountability Act (HIPAA) form according to institutional guidelines
863
Signed written informed consent in accordance with federal, local, and institutional guidelines
864
Voluntary written consent
865
Ability and willing to give consent
866
? 18 years old at the time of informed consent.
867
Ability to give written informed consent and willingness to comply with the requirements of the protocol
868
Voluntary consent form
869
Written informed consent has been obtained
870
Voluntary written consent must have been given before performance of any study related procedure not part of standard medical care, with the understanding that consent may have been withdrawn by the participant at any time without prejudice to future medical care.
871
All patients and/or their parents or legal guardians must sign a written informed consent
872
Ability to give written informed consent and willingness to comply with the requirements of the protocol
873
Refusal or inability to give informed consent to participate in the trial
874
Ability to give written informed consent according to local guidelines
875
The patient must be willing and able to comply with all study protocol requirements. The patient or a legally authorized representative must fully understand all elements of the informed consent and have signed the informed consent according to institutional and federal regulatory requirements
876
Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
877
Patient's Informed Consent. -
878
Written informed consent
879
Subject has no clinically significant co-morbidities (i.e. chronic illnesses existing simultaneously with and usually independent of breast cancer) that affect life expectancy. Subject has given written informed consent
880
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
881
Able and willing to sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
882
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent
883
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
884
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
885
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must be registered prior to treatment with study drug
886
Informed consent
887
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
888
Written informed consent
889
Voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
890
All patients must demonstrate the ability to understand the investigational nature of this study and must sign a written informed consent document in accordance with institutional and federal guidelines
891
Signed written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent
892
Written informed consent prior to registration on study
893
Voluntary written consent
894
Voluntary written consent
895
Inability to give informed consent
896
Ability to give informed consent; for recipients and donors < 18 years of age, their legal guardian must give informed consent; pediatric patients will be included in an age appropriate discussion in accordance with institutional guidelines
897
MATCHED RELATED DONOR: Age >= 2 and =< 60 years old and able to give consent or assent; for donors < 18 years old, the legal guardian must be able to provide informed consent and an evaluation by a licensed social worker (LSW) or psychiatric personnel will be needed to determine willingness to participate; pediatric patients will be included in an age appropriate discussion in accordance with institutional guidelines
898
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
899
Written and voluntary informed consent
900
Patient must be capable of, and must voluntarily agree to participate by giving written informed consent
901
The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
902
Inability to understand or give an informed consent
903
Has given written Informed Consent
904
Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information
905
Patients must give written informed consent
906
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
907
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
908
Patients must sign an informed consent and authorization indicating that they are aware of the investigational nature of this study and the known risks involved
909
Ability to understand and the willingness of the patient, parent or legal guardian to provide informed consent
910
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
911
Voluntary written informed consent
912
Willing to provide voluntary written informed consent before performance of any study related procedure not part of normal medical care
913
Written, voluntary informed consent
914
Written informed consent in accordance with federal, local, and institutional guidelines; the patient must provide informed consent prior to the first screening procedure
915
Written informed consent
916
Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital
917
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
918
Voluntary written consent
919
Subjects must be willing to give written informed consent, and sign an institutionally approved consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
920
Psychiatric or addictive disorders that would preclude obtaining informed consent
921
Any medical condition, that would prevent the subject from signing the informed consent form.
922
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
923
Signed Written Informed Consent\r\n* Before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel\r\n* Written consent will include a Health Insurance Portability and Accountability Act (HIPAA) form according to institutional guidelines
924
Written informed consent and assent as is age appropriate
925
Patient or parent/guardian capable of providing informed consent
926
Ability to understand the investigational nature of this study and to give informed consent
927
Written informed consent
928
Written informed consent according to institutional guidelines
929
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
930
Inability to understand or give an informed consent
931
All patients must sign an IRB approved informed consent indicating their awareness of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information.
932
Ability to understand informed consent and signing of written informed consent document prior to initiation of protocol therapy
933
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
934
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
935
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital
936
Ability to give voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
937
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n*NOTE: HIPAA authorization may be included in the informed consent or obtained separately
938
Inability to give voluntary informed consent or guardian’s informed consent
939
Subjects must be able to understand and be willing to sign the written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information. A signed informed consent form (ICF) must be appropriately obtained prior to the conduct of any trial-specific procedure. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
940
Ability to give informed consent
941
Written, informed consent and assent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) guidelines
942
Inability or unwillingness or research participant or legal guardian/representative to give written informed consent
943
Written Informed Consent
944
Written informed consent must be provided.
945
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
946
Ability to give informed consent
947
Patients and/or their parents or legal guardians must be capable of understanding the investigational nature, potential risks and benefits of the study. All patients and/or their parents or legal guardians must sign a written informed consent.
948
All subjects must have the ability to understand and the willingness to sign a written informed consent; they are to give voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
949
Written informed consent/assent before any study-specific screening procedures. For pediatric patients, consent will be obtained from parent(s) or legal guardian(s) and the signature of at least 1 parent or guardian will be required. Investigators will also obtain assent of patients according to local, regional or national guidelines.
950
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
951
Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
952
Written informed consent in accordance with federal, local, and institutional guidelines
953
Able to give informed consent, or their legally authorized representative can give informed consent
954
Psychiatric disorder that would preclude patients from signing an informed consent
955
Any condition that may compromise the ability to give written informed consent or to comply with the study protocol.
956
Each patient must be aware of the nature of her disease process and must willingly consent to treatment after being informed of alternatives, potential benefits, side effects, and risks; eligibility testing that is considered standard of care may be done prior to informed consent but no immunotherapy related procedures or testing may occur without informed consent
957
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
958
Competent to give informed consent
959
Study subjects must sign an approved informed consent and authorization permitting release of personal health information
960
Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
961
Psychiatric conditions/diseases that impair the ability to give informed consent or to adequately co-operate
962
Patients must give documented informed consent to participate in this study
963
Written informed consent
964
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
965
Patients must be informed of the investigational nature of this study and sign written informed consent in accordance with institutional and federal guidelines
966
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
967
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
968
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
969
Patients must sign an informed consent form approved for this purpose by the IRB of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks
970
Must have provided informed consent for study participation.
971
Able and willing to sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
972
Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
973
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
974
Ability to understand the nature of this study and give written informed consent.
975
Patients must give informed consent
976
Ability to understand the nature of this trial and give written informed consent
977
Subject (and/or parent/guardian for subject who otherwise is unable to provide independent consent, if acceptable to and approved by the site and/or site's IRB) must be willing to give written informed consent and be able to adhere to dose and visit schedules.
978
Ability to give informed consent
979
Signed informed consent that details the investigational nature of the study according to institutional and federal guidelines
980
Provision of written informed consent
981
Ability to give informed consent; for patients < 18 years of age their legal guardian must give informed consent; pediatric patients will be included in age-appropriate discussion in order to obtain verbal assent
982
Patient or patient’s legal representative, parent(s) or guardian able to provide written informed consent for the long-term follow-up gene therapy study 2006-0676
983
Written informed consent or assent
984
Voluntary, written informed consent.
985
Patients must have the ability to understand and voluntarily sign a written informed consent; if an unexpected non-English speaking patient or if an illiterate patient is encountered, current Institutional Review Board (IRB) guidelines on obtaining informed consent will be followed; a voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
986
Has given written informed consent.
987
Patients must voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
988
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
989
Lack of ability or willingness to give informed consent
990
Voluntary written informed consent
991
Patients capable of providing written, informed consent
992
Written informed consent
993
Patient must understand and voluntarily sign an informed consent form, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care
994
The subject must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
995
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital.
996
Subjects must give written informed consent to participate in this trial
997
Voluntary written consent
998
Able to provide voluntary written informed consent, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
999
All patients, or their legal guardians, must sign a written informed consent in accordance with institutional guidelines
1000
Written informed consent to participate in this study before the performance of any study-related procedure
1001
Patient (or legal representative where appropriate) must be capable of providing written informed consent.
1002
Patient is capable of giving informed consent.
1003
Patient is an adult, female ? 18 years old at the time of informed consent
1004
Written informed consent which is consistent with International Conference on Harmonization, Good Clinical Practice (ICH-GCP) guidelines and local legislation.
1005
Written informed consent and HIPAA authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
1006
All patients and/or their parents or legal guardians must sign a written informed consent
1007
Men and women ? 18-years-old on the day of signing informed consent.
1008
Informed consent
1009
Willingness to sign informed consent by patient or patient’s legal representative
1010
Research participant or legal guardian/representative must be willing to give written informed consent
1011
Willing and able to understand and provide written informed consent. For minors or those incapable of providing written informed consent (i.e., incapacitated), understood, written and informed consent must be provided by a parent or legal guardian or representative.
1012
Patient or his or her legal representatives must give written informed consent and privacy authorization prior to participation in the study.
1013
Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate.
1014
Ability to give written informed consent and willing to comply with the requirements of the protocol; and for Part 3, to give written informed consent for 2 cancer biopsy procedures
1015
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study
1016
Inability to give an informed consent
1017
Patients must have the ability to give informed consent
1018
Patients must have the ability to give informed consent
1019
Written informed consent in accordance with federal, local, and institutional guidelines
1020
Unable to give informed consent
1021
Inability or unwillingness or research participant or legal guardian/representative to give written informed consent
1022
Research participant or legal guardian/representative is able and willing to give written informed consent
1023
Patient must have the ability to give written informed consent
1024
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
1025
Written informed consent that is consistent with ICH-GCP guidelines and local regulations
1026
Written informed consent;
1027
REGULATORY CRITERIA: Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
1028
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
1029
Provision of written informed consent
1030
patient had given written informed consent.
1031
All patients and/or their parents or legal guardians must sign a written informed consent
1032
Written informed consent obtained before undergoing any study-related activities
1033
Has provided written informed consent prior to any study related activities.
1034
Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the USA) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
1035
Subject has provided informed consent or subject's legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
1036
Has the subject given written informed consent?
1037
Written informed consent provided.
1038
The subject has read and understood the written informed consent form (ICF) and is willing and able to give informed consent, fully understands the requirements of the trial and is willing to comply with all trial visits and assessments, including completion of patient-reported measures. Consent must be given before any trial related activities.
1039
Patient is an adult ? 18 years old at the time of informed consent.
1040
Has provided written informed consent
1041
Provision of informed consent
1042
Voluntary signed informed consent before performance of any study-related procedure not part of normal medical care, indicating that that the patient is aware of the investigational nature of the study in keeping with the policies of MD Anderson Cancer Center (MDACC) and with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
1043
Eligible to give informed consent to participate in the study.
1044
Voluntary written consent must be given before performance of any study-related procedure
1045
Written informed consent has been obtained
1046
Inability to give informed consent
1047
Voluntary written informed consent
1048
All patients and/or their parents or legal guardians must sign a written informed consent
1049
Voluntary written consent must be given before performance of any study-related procedure
1050
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
1051
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
1052
All patients must be informed of the investigational nature of this study; patients or a legally authorized representative must sign and give written informed consent in accordance with institutional and federal guidelines
1053
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
1054
Written informed consent in accordance with federal, local, and institutional guidelines
1055
Written informed consent in accordance with federal, local, and institutional guidelines
1056
Lack of ability or willingness to give informed consent.
1057
Patients must sign an Informed Consent and Authorization indicating that they are aware of the investigational nature of this study and the known risks involved
1058
All patients must be informed of the investigative nature of the clinical trial and give written informed consent in accordance with institutional and federal guidelines
1059
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
1060
Willingness to consent to research biopsy
1061
Patients who give a written informed consent
1062
Written voluntary informed consent: the patient is capable of complying with the requirements of the written Informed Consent Form and complying with protocol requirements
1063
Cognitive impairment sufficient to render the patient incapable of giving informed consent
1064
Written informed consent in accordance with federal, local, and institutional guidelines
1065
Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements
1066
Written informed consent - a signed informed consent and/or assent (as age appropriate) for study participation including PK sampling will be obtained according to institutional guidelines.
1067
Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
1068
Written informed consent - a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines.
1069
Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients or their legal guardians (if the patient is < 18 years old); when appropriate, pediatric patients will be included in all discussions; this can be accomplished through one of the following mechanisms: a) the NCI, POB screening protocol, b) an Institutional Review Board (IRB)-approved institutional screening protocol or c) the study-specific protocol; documentation of the informed consent for screening will be maintained in the patient’s research chart; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for baseline values even if the studies were done before informed consent was obtained
1070
Unable to give informed consent
1071
All subjects must have the ability to understand and the willingness to sign a written informed consent; only lucid patients qualified to consent to neurosurgical procedure will be approached for participation in this study
1072
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
1073
Written informed consent in accordance with federal, local, and institutional guidelines.
1074
Signed informed consent according to institutional guidelines must be obtained; assent, when appropriate, will be obtained according to institutional guidelines
1075
Voluntary written informed consent before performance of any study-related procedure not part of routine medical care with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
1076
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
1077
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
1078
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
1079
Voluntary written consent
1080
Ability to give written informed consent.
1081
Written informed consent.
1082
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
1083
Written informed consent which is consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and local legislation.
1084
Subjects willing and able to give written informed consent to participate in the study and to adhere to the procedures stated in the protocol, or legally acceptable representative willing and able to give written informed consent on behalf of the subject for minors, unconscious adults and those incapable of consenting themselves due to their medical condition, or included as permitted by local regulatory authorities, IRB/IECs or local laws.
1085
All patients and/or their parents or legal guardians must sign a written informed consent
1086
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal regulations
1087
Written informed consent in accordance with federal, local, and institutional guidelines
1088
Capable of given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
1089
The patient is >= 18 years of age at the time of signature of the first informed consent form.
1090
Written informed consent and HIPAA authorization for release of personal health information.
1091
Inability to give informed consent
1092
Patient or patient's legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant's age is at least seven and less than eighteen years
1093
Patients must give written informed consent
1094
Parental informed consent
1095
Patient or patient's legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant's age is at least seven and less than eighteen years
1096
Because significant time will have elapsed between apheresis/tumor biopsy and the initiation of immunotherapy, all patients or their legal guardians (if the patient is < 18 years old) must sign a second informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility)
1097
All patients or their legal guardians (if the patient is < 18 years old) must sign a document of informed consent (screening protocol) prior to performing studies to determine patient eligibility; after confirmation of patient eligibility all patients or their legal guardians must sign the protocol specific informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility)
1098
Inability or unwillingness of research participant or legal guardian or representative to give written informed consent
1099
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must sign an authorization for the release of their protected health information
1100
All patients must sign an informed consent document indicating that they are aware of the investigational nature of this study
1101
Patient has given written informed consent which must be consistent with the International Conference on Harmonization, Good Clinical Practice (ICH-GCP) and local legislation.
1102
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
1103
Written informed consent following institutional and federal guidelines
1104
The patient is >= 18 years of age at the time of signature of the informed consent form.
1105
Inability to give informed consent because of psychiatric problems, or complicated medical problems.
1106
Provision of written informed consent.
1107
Patients must be capable of signing an informed consent
1108
Written informed consent in accordance with institutional and Food and Drug Administration (FDA) guidelines must be obtained from parent or legal guardian
1109
Written informed consent obtained from subject or subject’s legal representative and ability for subject to comply with requirements of the study
1110
Subjects must have given written informed consent to agree to participate
1111
Documented informed consent of the participant and/or legally authorized representative
1112
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
1113
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
1114
Written informed consent in accordance with federal, local, and institutional guidelines
1115
Subjects must have given written informed consent
1116
Informed consent and Health Insurance Portability and Accountability Act (HIPAA) signing
1117
Voluntary written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
1118
All patients must be informed of the investigational nature of the study and standard alternative therapies; all patients must sign and give written informed consent in accordance with institutional and federal guidelines
1119
Have the ability to give written informed consent
1120
All patients and/or their parents or legal guardians must sign a written informed consent
1121
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
1122
All patients and/or their parents or legal guardians must sign a written informed consent (patient assent is also recommended when applicable according to each institution’s policy)
1123
Capable of providing informed consent
1124
Women with cognitive impairment that precludes informed consent and those unable to provide consent in English
1125
Providing informed consent
1126
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information \r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
1127
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must sign an authorization for the release of their protected health information
1128
PHASE I: For patients < 18 years, parents must give informed consent and patient must give assent; patients >= 18 must give informed consent
1129
PHASE II: For patients < 18 years, parents must give informed consent and patient must give assent; patients >= 18 must give informed consent
1130
Lack of ability to give informed consent
1131
Ability to give informed consent
1132
Patient must have given written informed consent according to Food and Drug Administration (FDA) guidelines
1133
Patient or parent(s)/legal guardian(s) is able and willing to provide informed consent; assent will be obtained per local institutional policy; subjects who turn 18 during the course of the study will be consented at that time of their next visit by a member of the research staff
1134
Informed consent
1135
Subject has provided informed consent.
1136
Patients must give voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
1137
Written informed consent and any locally required authorization
1138
Subject (or legally authorized representative) has voluntarily agreed to participate by giving written informed consent in accordance with ICH GCP guidelines and applicable local regulations.
1139
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
1140
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
1141
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
1142
Ability to understand and/or the willingness of the patient (or parent or legally authorized representative, if minor) to provide informed consent, using an institutionally approved informed consent procedure
1143
Subject understands and signs the Informed Consent
1144
Capable of giving informed consent
1145
Subjects given written informed consent.
1146
Written, informed consent
1147
Patients with obvious unresectable disease prior to signing informed consent
1148
Written informed consent.
1149
People unable to read and understand the informed consent document because of language difficulties
1150
Inability or unwillingness of individual to give written informed consent
1151
Subjects must be capable of giving informed consent
1152
Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
1153
Capable of giving informed consent
1154
Subjects are capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject’s behalf
1155
The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained in accordance with the institutional policies approved by the United States (U.S.) Department of Health and Human Services; informed consent must be signed prior to registration on study
1156
Documented written informed consent of the participant
1157
Unable to give informed consent
1158
HSCT CGs: Able to give written informed consent
1159
Ability to give informed consent.
1160
Unable to give informed consent
1161
Subjects who cannot give an informed consent
1162
Cognitively unable to give informed consent
1163
Patients that consent to participate
1164
Has provided written informed consent
1165
Receiving elotuzumab and/or other study drugs at the time of signature of informed consent
1166
Treating oncologist consent
1167
Patient must give informed consent for this new study
1168
Not giving consent for study participation
1169
DCG: Is capable of providing informed consent
1170
Voluntary written consent
1171
Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17 year olds)
1172
Sign an informed consent indicating they are aware of the investigational nature of this study
1173
Providing informed consent
1174
Treating oncologist consent
1175
Medical record documentation of cognitive impairment that would preclude the ability to provide informed consent
1176
Written, informed consent
1177
Subjects are capable of giving informed consent
1178
Voluntary written consent
1179
Patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study
1180
Refusal of informed consent
1181
Must be able to give voluntary informed written consent to participate in the study; informed consent will be obtained prior to starting of remission IC (can be obtained even on the first day of remission IC if obtained before administration of chemotherapy) and before any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
1182
Voluntary written consent
1183
Documented informed consent of the participant and/or legally authorized representative
1184
Subjects are capable of giving informed consent.
1185
Written informed consent
1186
Must give written study consent
1187
Any patient with cholestasis due to suspected MHO who provides written informed consent.
1188
Ability to give informed consent
1189
Each subject must be aware of the nature of his current medical condition and must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts
1190
All patients and/or their parents or legal guardians must sign a written informed consent
1191
This protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consent
1192
Voluntary written informed consent before study entry, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
1193
This protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consent
1194
Patients who are confused and unable to give informed consent
1195
All subjects must have the ability to understand and the willingness to participate in the informed consent process, although a waiver of written informed consent is obtained for this study
1196
Patients must give informed consent
1197
All patients and/or their parents or legal guardians must sign a written informed consent
1198
All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
1199
Patients will have provided informed consent to participate, documented by their signature on the study consent form
1200
All patients and/or their parents or legal guardians must sign a written informed consent
1201
For donors < 18 years of age, their legal guardian must give informed consent, the donor must give written assent
1202
All patients and/or their parents or legal guardians must sign a written informed consent
1203
Written informed consent and assent as required by institutional guidelines
1204
Able to provide informed consent or, if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (per institutional policies) must sign consent by the baseline visit
1205
All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
1206
Properly obtained written informed consent
1207
All patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
1208
Gives written informed consent
1209
Gives written informed consent
1210
Cannot give informed consent.
1211
All patients must be informed of the investigational nature of this study and must sign and give written informed consent for aim 1 study activities in accordance with institutional and federal guidelines
1212
Men and women with literacy as demonstrated by reading and signing informed consent form
1213
Presence of relatively intact cognition defined by normal memorial delirium assessment scale (< 7/30); sign written informed consent
1214
Neurocognitive deficits that impair ability to give informed consent
1215
Inability to give informed consent
1216
Inability to provide informed consent; potential participants will be identified by our collaborating physicians
1217
All patients to give written informed consent to participate
1218
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
1219
Has the ability to read and understand subject Informed Consent Form (ICF).
1220
Ability to give informed consent
1221
Written informed consent and Health Insurance Portability and Accountability Act of 1966 (HIPAA) authorization for release of personal health information.
1222
Participants must be capable of understanding and complying with the protocol requirements and signing informed consent
1223
Have the ability to understand, and have given written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
1224
Patients with psychiatric or addictive disorders that would preclude obtaining informed consent
1225
Unable to give written informed consent
1226
Capable of providing informed consent
1227
Written informed consent obtained prior to any study-related procedure being performed;
1228
Provision of written informed consent to participate in this investigational study
1229
Patients must give informed consent according to the rules and regulations of the individual participating sites
1230
Subjects must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rules
1231
Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q questionnaires
1232
Written informed consent
1233
Legally authorized representative consent
1234
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
1235
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
1236
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
1237
Patients refusing to sign informed written consent for participation in research
1238
All patients and/or their parents or legal guardians must sign a written informed consent (patient assent is also recommended when applicable according to each institution’s policy)
1239
Diagnosis of dementia or unable to grant their own informed consent
1240
Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
1241
Willing to consent to participate
1242
The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study, as has his/her responsible caregiver, if applicable
1243
Patient must have adequate kidney function as measured by eGFR greater than or equal to 50 calculated from a standard care serum creatinine performed within 30 days prior to the PN; patient must be able to give written informed consent
1244
Informed Consent: Each patient must be aware of the neoplastic nature of his/her disease process and must willingly sign a study-specific consent prior to randomization after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts (human protection committee approval of this protocol and consent form is required)
1245
Adequately informed of the nature and risks of the study with written informed consent
1246
All patients and/or their parents or legal guardians must sign a written informed consent
1247
Written informed consent obtained in accordance with institutional policies approved by the United States (U.S.) Department of Health and Human Services
1248
Incapable of giving informed consent
1249
Parent or legal guardian consent
1250
Give written informed consent
1251
This protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consent
1252
Subject or authorized representative has provided informed consent.
1253
Participant/parent/legally authorized representative (LAR) unwilling to give written informed consent
1254
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
1255
Participants must be capable of providing written informed consent for study participation
1256
People unable to read and understand the informed consent document because of language difficulties
1257
Inability or unwillingness of individual to give written informed consent
1258
Properly obtained written informed consent
1259
Willingness to give informed consent
1260
Patients unable to give informed consent
1261
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
1262
Patients with obvious unresectable disease prior to signing informed consent
1263
Capable of giving informed consent
1264
Informed consent
1265
Voluntary written consent signed before performance of any study-related procedure not part of normal medical care
1266
Ability to sign informed consent and understand the nature of a placebo-controlled trial
1267
Subjects who are unable to give informed consent
1268
Unable to give informed consent
1269
Patients who are unable to give informed consent
1270
Subjects capable of giving informed consent
1271
Any patient/volunteer unable to give informed consent
1272
Patients do not have the ability to give informed consent
1273
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
1274
All patients and/or their parents or legal guardians must sign a written informed consent
1275
Patient or parent/legal guardian or representative has a psychiatric illness that would prevent the patient or parent/legal guardian or representative from giving informed consent and/or assent.
1276
Patient or parent/legal guardian or representative lacks the full mental capacity to understand and sign a written informed consent.
1277
Parent/legal guardian willing and capable of signing written informed consent
1278
Written informed consent in accordance with institutional and FDA (food and drug administration) guidelines must be obtained from all subjects (or patients' legal representative).
1279
DONOR: Ability to comprehend the investigational nature of the study and provide informed consent
1280
Able to perform written, informed consent
1281
Voluntarily agree to participate and read the informed consent documents
1282
Written consent
1283
Patients unable or unwilling to provide informed consent or sign a written informed consent document (ICD)
1284
Signed written informed consent (patient must be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent)
1285
Written informed consent
1286
Patient has been informed of the investigational nature of this study and has given written Informed Consent and is able to adhere to dosing and visit schedules and meet all study requirements
1287
Patient or the patient's legally authorized guardian must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects), and must sign an informed consent in accordance with the institutional policies approved by the U.S. Department of Health and Human Services
1288
Willingness to give informed consent
1289
Given written informed consent (patient and donor)
1290
Unwilling to give informed consent
1291
A willingness to follow the study protocol, as indicated by provision of informed consent to participate
1292
Voluntary written consent signed by the subject (or the subject’s legally authorized representative)
1293
Subjects consent to participate in the trial
1294
SMOKING CESSATION SUB-STUDY: Written informed consent will be obtained by trained study personnel from all participants
1295
Written informed consent in accordance with institutional guidelines
1296
Subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them
1297
Written signed informed consent; patients must be aware of their diagnosis and willingly consent after being informed of the investigational nature of the intervention, alternatives, potential benefits, side-effects, risks, and discomforts
1298
Subjects who cannot give an informed consent
1299
Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
1300
Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
1301
Willing to give written informed consent, adhere to the visit schedules and meet study requirements
1302
Patients must give written informed consent to participate in this study before the performance of any study-related procedure.
1303
Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
1304
Subject must have provided written Informed Consent
1305
Informed Consent: All patients and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
1306
Written informed consent and authorization to use and disclose health information
1307
Subject is ? 18 years of age at the time of signing the informed consent form (ICF).
1308
Provision of informed consent by primary caregiver
1309
Subject consent and authorization for the release of health information must be obtained according to local institutional guidelines
1310
Provision of informed consent
1311
Patients must be fully informed of the investigational nature of this study and must sign an informed consent in accordance within institutional and Food and Drug Administration (FDA) guidelines
1312
Inability to give informed consent
1313
Capable of informed consent
1314
Written informed consent obtained from the subject.
1315
Written informed consent obtained from the subject
1316
Patients must have an ability to understand and the willingness to sign a written informed consent document; the patient is still eligible for this study even if she declines consent for her tissue to be used for any (or all) of the correlative studies described in this document and/or if she declines consent for her tissue to go into a tissue bank for future unspecified research
1317
Signed informed consent by subject (age >= 18 years) or by parent/guardian (subject age < 18 years); information will be provided to potential subjects and their parents/guardians (as appropriate) by oral discussion with opportunity for question and answer and the written informed consent document; subjects less than 18 years of age capable of giving assent will be included in these discussions and will be asked for written assent on the same document as the parents/guardians give consent; if feasible, both parents (or guardians) will be included in these discussions and will be asked to sign the written consent document; if a second parent or guardian is unavailable, this will be explained in writing on the written consent document; if subjects age 18 years or older are unable to provide informed consent, then they will not be enrolled in this study
1318
The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization
1319
Inability to give informed consent
1320
Individuals able to give informed consent, or a signature from a designated health care proxy or legal guardian
1321
Ability to understand and the willingness of the patient, parent or legal guardian to provide informed consent
1322
Unable to give written, informed consent
1323
Patients unable or unwilling to provide informed consent or sign a written informed consent document (ICD)
1324
All subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
1325
Ability to provide informed consent; all subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed
1326
Patients must sign an informed consent, and be mentally responsible
1327
Participant will be fully informed and has personally signed and dated the written informed Consent and Health Insurance Portability and Accountability Act (HIPAA) provisions
1328
Be capable of signing and providing written consent in accordance with institutional and federal guidelines
1329
Cannot consent for himself or herself
1330
Patients must have signed an approved informed consent and authorization permitting release of personal health information; ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
1331
All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
1332
Ability to provide written informed consent in accordance with institutional policies
1333
Subjects who refuse to participate, or demonstrate inability to give informed consent
1334
All subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
1335
All subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
1336
Ability of the subject, or the legally authorized representative (LAR) if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, to understand, and the willingness to sign, a written informed consent.
1337
Patients cannot give informed consent.
1338
Patient provides written informed consent
1339
Sign written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
1340
Patient or legal parent/guardian unable to provide informed consent
1341
Psychiatric or addictive disorders that preclude obtaining informed consent
1342
Patients who cannot consent for themselves
1343
Subject or legally authorized representative signs study-related informed consent document
1344
Subject capable of giving informed consent and participating in the process of consent
1345
Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study
1346
Only individuals who can understand and give informed consent will be eligible to participate in this study
1347
Subject capable of giving informed consent and participating in the process of consent
1348
Unwilling to give informed consent
1349
Written informed consent
1350
CAREGIVER/PARENT: Caregivers (parents or legal guardians) must give informed consent
1351
All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
1352
Inability to give informed consent
1353
Patients unable or unwilling to provide informed consent or sign a written informed consent document (ICD)
1354
Valid informed consent by subject or subject’s legally authorized representative (LAR)
1355
Individuals who are not willing or capable of giving informed consent or assent (with legal guardian consent)
1356
Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines
1357
Informed consent
1358
All patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
1359
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the cancer center
1360
Inability or unwillingness of research participant, parent, or legal guardian/representative to give written informed consent
1361
EXCLUSION CRITERIA FOR OPEN-ACCESS: Inability or unwillingness of research participant, parent, or legal guardian/representative to give written informed consent
1362
All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
1363
Informed consent
1364
Have the ability to give informed consent
1365
Give written informed consent
1366
All patients or their legal guardians (if the patient is < 18 years of age) must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study; when appropriate, the minor patient will be asked for oral assent; the parent or guardian will sign the consent form on the designated line attesting to the fact that the minor has given assent
1367
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* Note: HIPAA authorization may be included in the informed consent or obtained separately
1368
Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities;
1369
Patient or patient's legally acceptable representative cognitively provides written informed consent
1370
unwilling to give informed consent;
1371
Patient provides written informed consent
1372
Patient provides written informed consent
1373
All patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
1374
Psychiatric or addictive disorders that preclude obtaining informed consent
1375
Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
1376
Patients must give written informed consent
1377
Subjects who refuse to participate, or demonstrate inability to give informed consent
1378
Patient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure
1379
LOCALIZED RCC TREATED WITH PARTIAL NEPHRECTOMY:\r\nWritten informed consent available
1380
ADVANCED RCC TREATED WITH RADICAL NEPHRECTOMY:\r\nWritten informed consent available
1381
Women who cannot consent for themselves
1382
All participants, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
1383
Inability to give informed consent
1384
Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate
1385
Provides written informed consent
1386
Patients must be able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
1387
Patients who cannot consent for themselves
1388
Patients who cannot give informed consent
1389
Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of medical information
1390
Patients will have provided informed consent to participate, documented by their signature on the study consent form
1391
Patients will have provided informed consent to participate, documented by their signature on the study consent form
1392
Inability to give informed consent
1393
Written, informed consent and assent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) guidelines
1394
Ability to understand and willingness to sign a consent and Health Insurance Portability and Accountability Act (HIPAA) authorization form
1395
Provides written informed consent document
1396
Are unwilling to give informed consent
1397
Patients who have granted written informed consent for the study
1398
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of University of Michigan (UM) hospital
1399
Unable to give informed consent
1400
Written informed consent will be obtained from patients
1401
Subjects, or their legal guardian, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
1402
Subject has provided written informed consent with HIPAA authorization
1403
Provides written informed consent
1404
Written informed consent
1405
All patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
1406
Subjects incapable of giving informed written consent, for the following reasons:\r\n* Inability to adhere to the experimental protocols for any reason\r\n* Inability to communicate with the research team\r\n* Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders\r\n* Prisoners or other individuals deemed to be susceptible to coercion
1407
Provides written informed consent
1408
Patients incapable of giving informed written consent, for the following reasons:\r\n* Inability to adhere to the experimental protocols for any reason\r\n* Inability to communicate with the research team\r\n* Limited ability to give informed consent due to mental disability, altered mental status, confusion, cognitive impairment, or psychiatric disorders\r\n** Patients scoring 14.5 or lower on the University of California at San Diego (UCSD) Brief Assessment of Consent Capacity (UBACC) Capacity to Consent Questionnaire will be excluded\r\n* Prisoners or other individuals deemed to be susceptible to coercion
1409
Written informed consent
1410
Subjects incapable of giving informed written consent, for the following reasons:\r\n* Inability to adhere to the experimental protocols for any reason\r\n* Inability to communicate with the research team\r\n* Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders\r\n* Prisoners or other individuals deemed to be susceptible to coercion
1411
Written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines
1412
Ability to provide informed consent; all subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed
1413
Written informed consent
1414
Patient having provided his/her written informed consent to participate in the trial prior to any study-related procedure being conducted
1415
Inability to give informed consent
1416
Provides written informed consent
1417
Informed consent cannot be obtained either from the patient or legal representative
1418
Provides written informed consent and willing to comply with protocol requirements
1419
Ability of subject or legally authorized representative (LAR) (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of this study
1420
Provides written informed consent
1421
Written informed consent
1422
Inability to give informed consent in person
1423
Informed consent was obtained.
1424
All patients must give written informed consent
1425
Patient gives informed or surrogate consent
1426
Patient ability to read and comprehend the informed consent document
1427
Written informed consent signed by all patients and/or their parents or legal guardians (both parents/guardians if reasonably available)
1428
Written informed consent.
1429
Ability to understand informed consent and signing of written informed consent prior to initiation of protocol therapy
1430
Ability to give informed consent
1431
Inability to give informed consent.
1432
Valid informed consent by subject
1433
Able to give voluntary written informed consent
1434
Provides written informed consent
1435
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
1436
Subject has provided written informed consent to participate in the study
1437
Subject has provided written informed consent to participate in the study
1438
Unable to give informed consent
1439
Have the ability to understand and to give written informed consent as assessed by the participant’s primary care physician or medical oncologist
1440
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
1441
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
1442
Patients must have capacity to consent
1443
Unable to give informed consent
1444
Patient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure
1445
Individuals who are unable to give informed consent
1446
Informed Consent: Written informed consent must be obtained from subject or parent/legal guardian prior to enrollment. Assent, when appropriate, will be obtained according to institutional guidelines
1447
Patients who have initiated treatment for unresectable or metastatic melanoma at\n             medical practice (e.g. community-based, office-based, hospital-based, academic\n             setting)within 21 days before informed consent for this study OR in the case where\n             treatment has not yet been initiated, documentation that the treatment strategy was\n             determined before informed consent for this study, and treatment must be initiated\n             within 28 days after informed consent
1448
Subjects incapable of giving informed written consent
1449
Patients are capable of giving informed consent
1450
Provision of written informed consent
1451
Patients are capable of giving informed consent
1452
Men and women ? 18 years of age, at the time of signing the ICD (Informed Consent Document).
1453
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participants at any time without prejudice to future medical care.
1454
Subjects participating in another clinical investigation at the time of signature of the informed consent.
1455
Ability to understand the nature of this trial and give written informed consent.