Patient must be able to provide study-specific informed consent prior to study entry
Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable ICH guidelines and local and regulatory requirements prior to the performance of any study specific procedure.
Provision of informed consent prior to any study specific procedures
Patient must be able to provide study specific informed consent prior to study entry
The patient or legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
Patient must provide study specific informed consent prior to study entry, including the mandatory pre-treatment plasma EBV DNA assay
Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review
Patient must provide study-specific informed consent prior to study entry
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
The patient must provide study-specific informed consent prior to study entry
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Patient must provide study specific informed consent prior to study entry
Signed informed consent prior to study specific procedures.
Willingness and ability to consent to participate in study
Prior to any study specific activities, the patient must be aware of the nature of his/her disease and willingly consent to the study after being informed of study procedures, the experimental therapy, possible alternatives, risks and potential benefits
Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator
Written informed consent must be obtained prior to any screening procedures
Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Provision of signed and dated, written informed consent prior to any study specific procedures
Subjects must provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up \r\n* Note: informed consent may be obtained prior to start of the specified screening window\r\n* Note: procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study such as bone scan) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
Signed written informed consent obtained prior to performing any study procedure, including pre-screening and screening procedures.
Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study.
Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure; specifically able to comply with the PK assessment schedule during the first 2 treatment cycles.
Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
Signed informed consent prior to the performance of any study-specific procedures, including fresh tumor biopsies.
Ability to provide written informed consent which must be obtained prior to any screening procedures and according to local guidelines
Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
Patients must provide study specific informed consent prior to study entry
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: Subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by the IRB, prior to the initiation of any screening or study-specific procedures
Written informed consent must be obtained prior to any screening procedures other than procedures performed as part of standard of care.
Subject is able to understand and willing to sign the ICF, according to institutional standards, prior to the initiation of any study related procedures;
Subject has any medical, psychiatric, addictive or other disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures
Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures.
Patients must sign an informed consent prior to registration and before undergoing any study-specific procedures indicating that they are aware of the investigational nature of this study
Willingness and ability to provide written informed consent prior to any study?related procedures and to comply with all study requirements.
Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements
Provide written informed consent prior to any study-specific screening procedures
Written informed consent must be obtained prior to any screening procedures and according to local guidelines
Neurological or psychiatric disorders which may influence understanding of study and informed consent procedures.
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Subject or legal representative has ability to read, understand and provide written informed consent for study related procedures
Male or female ? 18 years of age. 4. Weigh ? 35 kg. 5. ECOG performance score 0-2, inclusively. 6. Negative ?-hCG test in women of childbearing potential. 7. Able to understand and comply with the requirements of the study and to provide written informed consent.
Patient must provide study specific informed consent prior to study entry
Patient must provide study specific informed consent prior to study entry
Written informed consent obtained prior to any study-specific procedures not considered part of routine medical care.
Written informed consent for screening and trial participation procedures including biological material transfer and handling.
The subject or the subject's legally acceptable representative provides written, informed consent prior to the initiation of any study procedures.
Provided written informed consent prior to any study-specific procedures.
Able to understand the study procedures and agree to participate in the study by providing written informed consent
Male or female, ? 18 years old with the ability to understand and provide signed and witnessed informed consent, and agree to comply with protocol requirements
Provide written informed consent prior to any study related procedure. (In the event that the patient is re-screened for study participation or a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed.)
Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements
Subject must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-specific assessments/procedures being conducted.
The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for study treatment and for submission of tumor samples as required by NSABP B-59/GBG 96-GeparDouze for baseline correlative science studies.
Signed written informed consent granted prior to initiation of any study-specific procedures.
Patient has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements
Written informed consent obtained prior to any study-specific procedures not considered part of routine medical care
Patient has signed the informed consent prior to any screening procedures being performed and is able to comply with the protocol requirements
Written informed consent obtained prior to any study-specific procedures not considered part of routine medical care
Understands and is willing to sign an informed consent form (ICF) prior to initiation of any study-specific procedure.
History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
The patient must provide study-specific informed consent prior to study entry
Patient must sign informed consent form to indicate patient's understanding study's purpose and procedures and willingness to participate. Should patient be incapable of giving consent, the patient's legally authorized representative (as defined by local regulation) must give consent. However, should patient, in any manner, choose not to participate this takes precedence and will be respected.
Patient must provide study-specific informed consent prior to study entry
Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable International Conference on Harmonization (ICH) guidelines and local and regulatory requirements prior to the performance of any study specific procedure.
The patient must provide study-specific informed consent prior to study entry
Has read and understands the informed consent form and has given written informed consent prior to any study procedures
Ability to provide and understand written informed consent prior to any study procedures
Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, and analyses. If a patient declines to participate in any voluntary exploratory research and/or genetic component of the study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspects of the study.
History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Able to provide signed and dated informed consent before initiation of any study procedures.
Provide signed, written informed consent prior to the initiation of any study-specific procedures
Able to provide written informed consent prior to the performance of any study-specific procedures.
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Provide written informed consent obtained prior to the initiation of study procedures
Patient must sign study specific informed consent prior to study entry
Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Written informed consent must be obtained prior to any screening procedures
Patient must consent to the study and provide a signed and dated, written informed consent document prior to any study-specific procedures, sampling, or analyses.
Able to understand and give written informed consent and comply with study procedures.
The patient has signed informed consent prior to initiation of any study-specific procedures or treatment.
Patients must sign a study-specific informed consent prior to study entry
Written informed consent provided prior to the initiation of study procedures
Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator
Patient must provide study-specific informed consent prior to study entry
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF)
Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
The patient or the patient’s legal representative is able to understand the risks of the study and provide signed informed consent and authorization to use protected health information (in accordance with national and local privacy regulations)
All patients must sign study specific informed consent prior to study entry
Patients must provide written informed consent prior to any study procedures
Patient must sign study specific informed consent prior to study entry
Any medical, psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures
Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
Patient must give study-specific informed consent on an IRB-approved consent prior to any research-related procedures or study treatment.
Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.
The ability to provide written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time
Able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the Investigator, to comply with all the requirements of the study.
Ability to understand the purpose and risks of the study and provide signed and dated informed consent
Is able to provide written informed consent (in English) to participate in the study and able to understand the procedures and study requirements
Provide written informed consent prior to any study-specific screening procedures.
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Have signed an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
Provision of informed consent prior to any study specific procedures
Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
Patients must sign a study-specific informed consent form prior to study entry
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
The subject must sign a written informed consent form prior to the initiation of any study procedures. Adult subjects unable to provide written informed consent on their own behalf will not be eligible for the study
Provision of written informed consent prior to any study-specific procedures
Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
After being fully informed about their illness and the investigative nature of the protocol (including foreseeable risks and possible toxicities), is willing and able comply with the protocol and to provide written, ethics committee-approved informed consent form before performance of any study-specific procedures or examinations
Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease
Subject has provided informed consent prior to initiation of any study-specific activities/procedures;
Any medical, psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures
Signed, informed consent must be obtained prior to any study specific procedures
Ability to understand and willingness to provide written informed consent signed and dated prior to admission to the study in accordance with International Conference on Harmonisation (ICH)-Good Clinical Practices (GCP) guidelines and to the local legislation
Willing to and capable of providing written informed consent prior to any study related procedures
Patient has any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures
Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements
Ability to provide a signed and dated consent or have a legally authorized representative to provide written and signed consent prior to the initiation of any research related procedures
Have signed an informed consent document indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study.
Provision of informed consent prior to any study specific procedures.
Written informed consent obtained from the subject prior to performing any protocol-related procedures
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
Have signed an informed document prior to any study-specific procedures or treatment
The patient or legally authorized representative must provide study-specific informed consent prior to study entry
The patient must provide study-specific informed consent prior to study entry
Voluntary written consent prior to the performance of any research related procedures
Understand the study requirements and the treatment procedures, and is willing to comply with all specified follow-up evaluations, and provides written informed consent before any study-specific tests or procedures are performed.
Willingness and ability to consent for self to participate in study
Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study.
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
The patient must provide study-specific informed consent prior to study entry; no durable power of attorney or next of kin can provide initial consent
Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Must have voluntarily agreed to participate and have signed the informed consent, and are willing to complete all study procedures.
Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluation
Participants must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease
Understand and voluntarily sign an informed consent document prior to conducting any study related assessments or procedures
Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Signed informed consent obtained prior to initiation of any study-specific procedures and treatment;
Subjects must sign a written informed study consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
Significant medical psychiatric cognitive or other conditions that may compromise the patient ability to understand the patient information to give informed consent to comply with the study protocol or to complete the study
Provide written, informed consent to participate in the study and follow the study procedures
Voluntary written consent prior to the performance of any research related procedures
Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure
Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.
Willing and able to provide written informed consent prior to performance of any study-specific procedures
Voluntary written consent prior to the performance of any research related procedures
Signed, informed consent must be obtained prior to any study specific procedures
Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses; including access to all archival tumour tissue (diagnostic and/or most recent samples)
Be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the subject before completing any study-related procedures.
Has any medical or psychiatric disorder that compromises the ability of the subject to give written informed consent, and/or comply with the study procedures.
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent for (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Be willing and able to understand and give written informed consent and comply with all study related procedures
Patients must sign informed consent form (ICF) and show ability and willingness to comply with the requirements of the study protocol
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Unwilling or unable to participate in all required study evaluations and procedures or unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
The patient/legal representative must be able to read and understand the informed consent form (ICF) and must have been willing to give written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the United States of America [USA]; European Union Data Privacy Directive in the European Union [EU]) before any study-specific procedures, including screening evaluations, sampling, and analyses
Written informed consent obtained prior to any screening procedures
Provision of signed and dated, written Informed Consent Form (ICF) prior to any trial-specific procedures, sampling, or analyses. If a patient declines to participate in the voluntary pharmacogenetics component of the trial, he/she will not be excluded from other aspects of the trial.
Capable of giving written informed consent prior to any study-specific procedures
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the study treatment regimen and follow-up, must be obtained and documented according to the local regulatory requirements
Ability to understand and the willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures
Written informed consent/assent prior to any study-specific procedures
Patients must provide study specific informed consent prior to study entry
Provide signed and dated informed consent prior to any study specific procedures.
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
Written informed consent must be obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI)
Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Patient must be aware of the neoplastic nature of his/her disease and willingly sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
Patient must capable of, and provide, study specific informed consent prior to study entry
Able to understand the potential risks, benefits, and requirements of the study and are willing to provide informed consent; an informed consent form for this study that is signed by the patient or his/her legally authorized representative is required prior to enrollment
Able to understand the potential risks, benefits, and requirements of the study and are willing to provide informed consent; an informed consent form for this study that is signed by the patient or his/her legally authorized representative is required prior to enrollment
Patients must have given written, signed and dated informed consent prior to registration on the study; NOTE: no study-specific screening procedures may be performed until consent has been given
Have signed an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
Signed written informed consent granted prior to initiation of any study-specific procedures
Provision of informed consent prior to any study specific procedures
Ability to provide written informed consent for the protocol must be obtained prior to any screening procedures; if consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
The patient must sign an informed consent form (ICF) indicating that s/he understands the purpose of, and procedures required for, the study and is willing to participate
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Written informed consent and any locally-required authorization (e.g.,) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Provide written, informed consent to participate in the study and follow the study procedures
Patient is willing to participate to the study, has the ability to adhere to the study visit schedule and other protocol procedures, and has the ability to understand and signs an informed consent form
Ability to give written, informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator
Signed informed consent prior to the start of any study specific procedures.
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study; written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization will be obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
All patients must sign study specific informed consent prior to study entry or within 1 week of first treatment, provided other criteria were met
Able and willing to provide written informed consent prior to performing any study-related procedures and to comply with the study protocol, including patients must be willing and able to use the electronic patient-reported outcome (ePRO) device
Written informed consent for the protocol must be obtained prior to any screening procedures
Provision of informed consent prior to any study specific procedures
Must be willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent
Provision of informed consent prior to any study specific procedures
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nAbility of subject to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluations
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nAbility of subject to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluations
Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures
Patient signs study specific informed consent prior to study enrollment
Ability to understand and willingness to sign the consent form written in English\r\n* Note: the consent form must be signed prior to the conduct of any trial-specific procedure
Patient must have the ability to understand the requirements of the study and provide informed consent.
Willingness and ability to consent for self to participate in study
Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
Written informed consent must be obtained prior to any screening procedures
Did the patient provide study-specific informed consent prior to study entry
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments
Patient must be able to provide study specific informed consent prior to study entry
Provide informed consent and agree to all assessments and study procedures
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Ability to understand and willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures
Sign (or their legally-acceptable representatives must sign) an informed consent document in accordance with institutional and federal guidelines indicating that they understand the investigational nature of and procedures required for the study, including biomarkers, and are willing to participate in and comply with the guidelines of the study
Capable of providing informed consent and complying with trial procedures.
Signed informed consent prior to the start of any study specific procedures.
Patient (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study
Provision of written informed consent prior to any screening procedures
Has provided written informed consent prior to completing any study procedures
Patient must be able to provide study specific informed consent prior to study entry
Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.
Patient must sign study specific informed consent prior to study entry
Patient must be informed of the investigational nature of this study in accordance with institutional and federal guidelines and have the ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the study
Have the ability to understand the requirements of the study, provide written informed consent which includes authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments.
Patient must be able to provide study-specific informed consent prior to study entry
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Capable of understanding the informed consent and complying with the protocol and signed the informed consent document prior to any study-specific screening procedures or evaluations being performed
Patient must provide study-specific informed consent prior to study entry
Patient must provide study specific informed consent prior to study entry
Subject must sign a study specific informed consent prior to study entry
Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.
Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed
Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice
Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subject‘s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
Adult subjects ?18 years of age who are able to understand study procedures, comply with them, and provide written informed consent before any study-specific procedure.
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
Written informed consent must be obtained from all patients prior to any study procedures
Unwilling or unable to participate in all required study evaluations and procedures; unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Patient must be able to provide study-specific informed consent prior to study entry
Signed and dated written ICF by the patient or legally acceptable representative prior to any study-specific procedures
Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);
Patient must give informed consent and sign an approved consent form prior to any study procedures.
Written informed consent must be obtained prior to any procedures unless considered standard of care.
Voluntary written consent prior to the performance of any research related procedures
Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
Patients must give study specific informed consent prior to enrollment
Signed, written informed consent must be obtained and documented according to ICH-GCP, the local regulatory requirements, and local data protection laws prior to study-specific screening procedures.
Patient or legally acceptable representative has granted written informed consent before any study specific procedures (including special Screening tests) are performed
Capable of providing informed consent and complying with trial procedures.
Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
Patients must be willing and able to give written informed consent prior to any protocol-specific procedures being performed and comply with the protocol requirements for the duration of the study.
Written informed consent prior to initiation of any study-related procedures;
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
101 Subject has provided informed consent prior to initiation of any study-specific activities/procedures OR subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated 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.
The patient or a legally authorized representative must provide study-specific informed consent and authorization permitting release of personal health information prior to study entry
Has read and understands the informed consent form (ICF) and has given written ICF prior to any study procedures
Provision of informed consent prior to any study specific procedures.
Must be willing to provide informed consent prior to any study specific procedures
Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
Inclusion Criteria:\n\n        Subjects who meet the following criteria will be eligible to participate in the Long-Term\n        Follow-Up study:\n\n          1. All adult and pediatric subjects who received at least one GM T cells infusion in a\n             previous Celgene sponsored or Celgene alliance partner sponsored study, and have\n             discontinued, or completed the post-treatment follow-up period in the parent treatment\n             protocol, as applicable.\n\n          2. Subject (and, parental/legal representative, when applicable) must understand and\n             voluntarily sign an Informed Consent Form/Informed Assent Form prior to any\n             study-related assessments/procedures being conducted.\n\n          3. Subject is willing and able to adhere to the study visit schedule and other protocol\n             requirements.\n\n        Exclusion Criteria:
Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Has read and understands the informed consent form and has given written informed consent prior to any study procedures.
Ability to understand and voluntarily sign informed consent prior to undergoing any study-related assessments or procedures, as well as adhere to the study visit schedule and other protocol requirements
Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.
Ability to understand and willingness to sign informed consent form prior to initiation of the study\r\nand any study procedures
Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA]) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
Patient must sign study specific informed consent prior to study entry
Has provided written informed consent, and has the willingness and ability to comply with all study procedures
RENAL & BLADDER: Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study
BLADDER: Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study
Written informed consent obtained from subject prior to any protocol related procedures
Voluntary written consent prior to the performance of any research related procedures
Unwilling or unable to participate in all required study evaluations and procedures or unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Provision of informed consent prior to any study specific procedures.
Signed written informed consent and Health Insurance Portability and Accountability Act (HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF
Patient has signed the informed consent form prior to the performance of any screening procedures and is able to comply with protocol requirements.
Ability to sign informed consent form; informed consent form for this study must be signed prior to the performance of any study-specific procedures and initiation of any study therapy
Signed informed consent prior to initiation of any study?specific procedure or treatment, including consent to provide blood samples for correlative studies and to obtain a tumor biopsy during the study
Patient has signed the Informed Consent Form (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements
The patient or a legally authorized representative must provide study-specific informed consent prior to study registration
The subject must be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the subject before completing any study-related procedures.
Adult subjects ?18 years of age who are able to understand and comply with study procedures, and provide written informed consent before any study-specific procedure.
The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration
Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry, including consent for mandatory tumor tissue, serum, and blood submission for immune correlatives (all patients) and p16 analysis (oropharyngeal cases only)
Patient must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for epidermal growth factor receptor (EGFR) analysis and for oropharyngeal cancer patients, human papilloma virus (HPV) analysis
Subjects must be able to understand the nature of this trial and provide written informed consent, prior to any study specific procedures; patients with Impaired Decision Making Capacity (IDMC) who have a close caregiver or legally authorized representative (LAR) may be considered eligible for this study at the treating physician’s discretion, provided that the physician is reasonably sure that the possible risks and benefits of the study are clear and that the patient will take the drug as prescribed
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
The patient must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Patient must have provided study specific informed consent prior to study entry
Must sign study-specific consent form
Patient or appointed surrogate decision-maker or legally authorized representative must have ability to understand the purpose and risks of the study and willingness to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study\n             specific evaluation
All patients must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with Institutional guidelines and good clinical practice (GCP) indicating that they understand the purpose of and procedures required for the study and are willing to participate prior to the beginning of any specific study procedures
Patient must be able to provide study-specific informed consent prior to study entry
Patient has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirement
Written informed consent must be obtained prior to any screening procedures and according to local guidelines
Written informed consent must be obtained prior to any screening procedures and according to local guidelines
The patient or a legally authorized representative must provide study-specific informed consent authorization permitting release of personal health information prior to study entry
The patient must provide study-specific informed consent prior to study entry, including consent for mandatory submission of tissue for required, central p16 review
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
Patient must provide study specific informed consent prior to study entry
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Patient must provide study specific informed consent prior to study entry
Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
Provision of fully informed consent prior to any study specific procedures
Participants must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
Patient must provide study specific informed consent prior to study entry
The patient must provide study-specific informed consent prior to study entry
Patient must provide study-specific informed consent prior to study registration
The patient must provide study specific informed consent prior to study entry
Patients must sign a study-specific informed consent prior to study entry
Patient must provide study specific informed consent prior to study entry
Age ? 18 years of age at the time of signing the Informed Consent Form. 2. Understand and voluntarily provide written consent to the Informed Consent Form prior to conducting any study related assessments/procedures.
Ability to understand and the willingness to participate in clinical research and comply with protocol procedures as evidenced by their signature on the informed consent form
Signed written informed consent and assent forms (if applicable) must be obtained prior to any study procedures
Written informed consent must be obtained prior to any screening procedures
Subject or his/her legally authorized representative or guardian understands and voluntarily signs an informed consent document prior to any study related assessments/procedures are conducted (except as noted in Section 6).
Able to understand and comply with the protocol and study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure is performed.
Provide written, informed consent to participate in the study and follow the study procedures
The patient has signed informed consent prior to initiation of any study-specific procedures or treatment.
The patient has signed informed consent prior to initiation of any study-specific procedures or treatment.
Patients must sign study specific informed consent prior to study entry
Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
Written informed consent by the patient (or legal representative) prior to admission to this study. In addition any locally required authorization (Health Insurance Portability and Accountability Act in the USA [HIPAA], obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator
Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted
Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for EGFR and for oropharyngeal patients, HPV analyses
Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
Understand and voluntarily sign a biomarker-specific component of the informed consent form prior to any study-related procedures conducted.
Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures;
Signed written informed consent before performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
Subject has provided informed consent prior to initiation of any study-specific activities/procedures
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 must be willing to comply with all study requirements and procedures.
Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
Understand and voluntarily sign an ICD (Informed Consent Document) prior to any study related assessments/procedures are conducted.
Understand and voluntarily sign and date an informed consent document prior to any study related assessments/procedures are conducted.
Have the ability to understand the requirements of the study, provide written informed consent, which includes authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments.
Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA) prior to study-specific screening procedures.
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
The patient must signed an informed consent form indicating that she/he understands the purpose of and procedures required for the study and is willing to participate in the study.
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
Willingness and ability to consent for self to participate in study
Patients must sign a study-specific consent form prior to study entry
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration
Voluntary written informed consent of the patient (both to participate in the study and to provide biopsy samples) obtained before any study-specific procedure.
The patient or a legally authorized representative must provide study-specific informed consent and authorization permitting release of personal health information prior to study entry
written informed consent obtained prior to any study-related procedures.
Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements (inclusive of 2 biopsies, one at baseline and if they qualify, one pre-randomization for part 2B)
Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
Written informed consent and any locally required authorization (eg, HIPAA) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Each participant (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Consent is to be obtained prior to the initiation of any study related tests or procedures that are not part of standard of care for the participant's disease
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Agree to study specific informed consent and HIPAA authorization for release of personal health information
The patient must provide study-specific informed consent prior to study entry
Patient must provide study specific informed consent prior to study entry
Ability to understand and the willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures
The signed informed consent form prior to the performance of any study related procedures that are not considered part of standard of care
Following receipt of verbal and written information about the study, patients must provide signed informed consent before any study-related activity is carried out.
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
Patient must capable of and provide study specific informed consent prior to study entry
Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Ability to provide written informed consent prior to participation in the study and any related procedures being performed
Patient must be able to provide study-specific informed consent prior to study entry
Patient must be able to provide study-specific informed consent prior to study entry
Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
The patient has signed informed consent prior to initiation of any study-specific procedures or treatment.
Provide written, informed consent to participate in the study and follow the study procedures
Be able to understand the study procedures, agree to participate in the study program, and voluntarily provide written Informed Consent
Ability to provide and understand written informed consent prior to any study procedures
Ability to understand the purpose of the study, provide signed and dated informed consent, and able to comply with all procedures
Patient has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements.
Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures required, including possibility of onset of exocrine pancreatic insufficiency with subsequent requirement for life-long pancreatic enzyme replacement
Ability to understand the nature of this study protocol, comply with study and/or follow-up procedures, and give written informed consent
Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted
Participant understands and voluntarily signs an informed consent document prior to any study related assessments or procedures are conducted.
Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
Patient must be able to provide study-specific informed consent prior to study entry
Provision of informed consent prior to any study specific procedures
Written informed consent must be obtained prior to any screening procedures
Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements.
Provided informed consent prior to initiation of any study-specific activities/procedures
Patients must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to adhere with treatment and follow-up
Patient provides signed and dated informed consent prior to initiation of any study procedures.
The patient must provide study-specific informed consent prior to study entry
Patients must be willing and able to comply with the protocol and provide written informed consent prior to study specific screening procedures
Provision of informed consent prior to any study specific procedures, sampling, and analysis.
Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures
Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent
Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
Must provide study-specific informed consent prior to study entry
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments
Any medical, psychiatric, addictive or other disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures.
Provision of informed consent prior to any study specific procedures, sampling and analyses.
Patient must sign a study-specific consent form prior to registration
Ability to understand and the willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures
Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).
Have signed an informed consent document indicating that the subjects understand the purpose of and procedures required for the study and are willing to participate in the study
Signed, informed consent must be obtained prior to any study specific procedures
Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures
Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
Provision of signed and dated written informed consent prior to any study specific procedures.
The patient (when applicable) or patient's parent(s) or legal guardian(s) understand(s) and voluntarily signed an informed consent document prior to any study-related assessments/procedures being conducted. Where locally applicable, the patient also understands and voluntarily provides his/her assent prior to any study-related assessments/procedures being conducted.
Have signed an informed consent document indicating that the subjects understands the purpose of and procedures required for the study and are willing to participate in the study
Patients must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up
Provide written, informed consent to participate in the study and follow the study procedures
The subject must provide study-specific informed consent prior to study entry
Participants must be willing and able to review, understand, and provide written consent before starting any study-specific procedures or therapy.
Have signed an informed consent document indicating that the subjects understands the purpose of and procedures required for the study and are willing to participate in the study
Provision of signed, written and dated informed consent prior to any study specific procedures
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Patients must sign an informed consent prior to registration and before undergoing any study-specific procedures indicating that they are aware of the investigational nature of this study
Signed, informed consent must be obtained prior to any study specific procedures.
All patients must be able to provide informed consent indicating that they are aware of the investigational nature of the study; patients must provide an authorization for the release of their protected health information
Written informed consent granted prior to initiation of any study-specific screening procedures, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
Informed consent must be obtained prior to study initiation
Subjects must provide written informed consent within one month prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up\r\n* Note: informed consent will be obtained after establishing the diagnosis of high risk, localized prostate cancer, and may be obtained prior to start of the specified screening window\r\n* Note: procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study such as bone scan) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
Subjects willing and able to comply with all aspects of the protocol for the duration of the study and provide written informed consent before any study-specific screening procedures are performed, with the understanding that the subject may withdraw consent at any time without prejudice
Written informed consent must be obtained prior to any study-related procedures
Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.
Have signed an informed consent document indicating that the subjects understands the purpose of and procedures required for the study and are willing to participate in the study
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH), Good Clinical Practice(GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures.
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Provision of signed, written and dated informed consent prior to any study specific procedures
Written informed consent obtained prior to any screening procedures performed
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Patient must be able to provide study-specific informed consent prior to study entry
Signed informed consent prior to the start of any study specific procedures.
Written informed consent obtained prior to any screening procedures
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI)
Have given written informed consent prior to any study procedures
Patient or designated individuals with durable medical power of attorney must give written informed consent prior to any study-specific procedures being implemented
Signed, informed consent must be obtained prior to any study specific procedures.
Provide signed informed consent after receipt of oral and written information about the study and before any study-related activity is performed
Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
Patients must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to adhere with treatment and follow-up
Informed consent must be obtained in writing for all patients prior to performing study/screening procedures and prior to registration into the study
Written informed consent obtained from the patient prior to performing any study-related procedures, including screening visits; available computed tomography (CT) scans, bone scans, and labs performed as standard of care prior to signing consent can be used to fulfill eligibility requirements if they were performed within 4 weeks of the first dose of AVX901; available multi gated acquisition scan (MUGA), echocardiogram, and electrocardiogram (EKG) performed as standard of care prior to signing consent can be used to fulfill eligibility requirements if they were performed within 8 weeks of the first dose of AVX901
The patient has a psychiatric, addictive, neurological or other disorder that compromises the ability to give informed consent or comply with study requirements
Subjects must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up
Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up \r\n* Procedures conducted as a part of routine clinical management of the subject (e.g., blood count, imaging study) and obtained prior to signed informed consent may be utilized for screening or baseline purposes provided these tests are obtained as specified in the protocol)
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Before any study procedures are performed, subjects (or their legally acceptable representatives) 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
Patient (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study
Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up; procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
Patients must provide study-specific informed consent prior to study entry
Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to undergoing study screening procedures
Have given written informed consent prior to any study-specific procedures
Subjects willing and able to comply with the study protocol for the duration of the study and provide written informed consent prior to any study-specific screening procedures with the understanding that the subject may withdraw consent at any time without prejudice.
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Have given written informed consent prior to any study-specific procedures
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
EXPANSION COHORT ONLY: Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
Signed written informed consent granted prior to initiation of any study-specific procedures
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Each patient must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease.
Provision of written signed informed consent prior to any study specific procedures;
Have signed an informed document prior to any study-specific procedures or treatment
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent. The subject must provide study specific informed consent prior to any protocol procedures that are not a part of standard care, including consent for assessment of HLA-A2 status, mandatory tissue submission for MAGE-A3 analysis and correlative studies.
Written informed consent and any locally-required authorization obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
Ability to understand and the willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures
Ability to understand and willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures
Written informed consent and HIPAA authorization (applies to covered entities in the USA only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
Subject understands and voluntarily signs an informed consent document prior to conducting any study related assessments/procedures
The patient must provide study-specific informed consent prior to study entry
Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study-specific evaluation
Able to provide signed and dated informed consent prior to initiation of any study procedures.
Written informed consent before any study-specific procedure is performed
Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
DONOR: Ability to understand and provide informed consent for all study procedures including partial liver transplant and bone marrow harvest
DONOR: Ability to understand and provide informed consent for all study procedures including liver transplant and bone marrow harvest
Willingness and ability to provide written informed consent prior to any study-related procedures and comply with all study requirements.
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Signed informed consent indicating that patients are aware of the investigational nature of this study, in keeping with the policies of MD Anderson Cancer Center (MDACC), must be obtained prior to any study specific procedures
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations).
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
Patient must provide study specific informed consent prior to study entry
Written informed consent must be obtained prior to any screening procedures
Provision of informed consent prior to any study specific procedures
Ability and willingness to give informed consent and ability to return to the study clinic during the study period
Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up
Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up
Any condition that would interfere with the ability to give informed consent or comply with the study protocol
Able to understand and give written informed consent and comply with study procedures.
Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice
Patient must provide study specific informed consent prior to study entry, including consent for mandatory screening of tissue
Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities
Patients must provide study-specific informed consent prior to study entry
Patient has been informed about the nature of the study and has agreed to participate in the study and signed the informed consent form prior to participation in any study-related activities
Patients must sign a study-specific informed consent form prior to study entry
Understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted.
Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments
Able to understand and give written informed consent and comply with study procedures.
Patient must provide a signed and dated written informed consent prior to registration and any study-related procedures
Have signed an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
Signed written informed consent obtained prior to performing any study procedure, including screening procedures.
Provide written informed consent prior to any study procedures.
Willing and able to provide written informed consent prior to performance of any study-specific procedures
Willing to adhere to protocol specific requirements 12. Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out. 13. Clinically significant toxic effects of prior therapy (expect hydroxyuria) resolved to Grade ? 1 before the start of study.
Ability to understand and voluntarily sign informed consent prior to undergoing any study-related assessments or procedures, as well as adhere to the study visit schedule and other protocol requirements
Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
Following receipt of verbal and written information about the study, patients must provide signed informed consent before any study-related activity is carried out.
Have signed an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
Written informed consent and any locally required authorization (e.g., HIPAA in the USA) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
The patient must sign specific informed consent prior to study entry
Understand and voluntarily provide written consent to the Informed Consent Form prior to conducting any study related assessments/procedures.
Ability to provide written informed consent, comply with protocol visits and procedures, take oral medication, and not have any active infection or chronic comorbidity that would interfere with therapy
Ability to read, understand and provide written consent to participate in the study
A written and voluntarily signed informed consent must be obtained from the patient or legally authorized representative, in accordance with local regulations, before the initiation of any study related procedures. The patient or legally authorized representative must be able to read and understand the informed consent form (ICF).
Subject 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 and date an Institutional Review Board-approved Informed Consent Form (including Health Insurance Portability and Accountability Act authorization, if applicable) before performance of any study specific procedures or tests.
Capable of providing informed consent and complying with trial procedures.
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
DONOR: Ability to understand and provide informed consent for all study procedures including kidney transplant and bone marrow harvest
Capable of providing informed consent and complying with trial procedures.
Informed consent given prior to study-specific screening procedures
Have signed written informed consent prior to the initiation of any study-specific procedures
Patients must have a written informed consent obtained prior to the initiation of study procedures
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments.
Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.
Significant medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol, or to complete the study
Patients must be capable of providing informed consent and must be willing to provide written informed consent prior to the start of any study-specific procedures.
PART I: Participants who have no language barrier, are cooperative, and can give informed consent before entering the study after being informed of the medications and procedures to be used in this study may participate
PART II: Participants who have no language barrier, are cooperative, and can give informed consent before entering the study after being informed of the medications and procedures to be used in this study may participate
Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.
Provide written informed consent prior to any study-specific procedures
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for required assessments.
Have the ability to understand the requirements of the study, provide written informed consent which includes authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments.
A written and voluntarily signed informed consent must be obtained from the patient or legally authorized representative, in accordance with local regulations, before the initiation of any study related procedures. The patient or legally authorized representative must be able to read and understand the informed consent form (ICF).
A signed informed consent must be obtained prior to any study-specific procedures.
Patients must sign study-specific informed consent and authorization for the release of their protected health information prior to registration; patients must be registered in the prior to treatment with study drug
Patients must be female, be ? 18 years of age, be able to understand the study procedures, and agree to participate in the study by providing written informed consent.
Written informed consent prior to completing any study-specific procedure
Able to understand the study procedures and agree to participate in the study by providing written informed consent Cohort Specific Inclusion Criteria:
On a stable parental study regimen (at least one cycle for the regimen at the dose/schedule that is to be given in the Treatment Extension study must have been given prior to the patient's discontinuation from the parental study). Signed written informed consent.
Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Signed written informed consent from either the subject, or their legally acceptable representative if the subject is incapable of giving their own consent, prior to performing any study-specific tests or procedures.
The patient must provide study specific informed consent prior to study entry
Have signed an informed consent document indicating that the subjects understands the purpose of and procedures required for the study and are willing to participate in the study
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations
Able to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements and for 3 months after last dose.
Give written informed consent prior to any study-specific procedures.
Willing and able to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures
Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study and follow-up procedures.
Provision of informed consent prior to any study-related procedures
The patient or their legally acceptable representative must be capable of giving written informed consent prior to performing any study-specific tests or procedures.
Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up; procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol; Note: it is not necessary that informed consent be obtained within the protocol-specified screening window
Written informed consent has been obtained prior to the performance of any protocol-specific procedure.
The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.
Ability to understand and to sign an informed consent form; a signed informed consent must be obtained prior to any study specific procedures
Participant or legal guardian, in the opinion of the investigator, is capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent; a signed informed consent must be obtained prior to any study specific procedures
Subjects must have provided written, informed consent prior to any study procedures: collection of blood and lymph node (LN) tissue specimens for this protocol
Able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject's privacy regulations).
Written informed consent has been obtained prior to the performance of any protocol-specific procedure.
The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.
Before any study-specific procedure is performed, the appropriate written informed consent must be obtained
Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Must give study specific informed consent prior to enrollment. For re-administration, patients must be re-consented.
Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study
Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
Written informed consent prior to any study specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice
Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
Ability to provide written informed consent for the protocol must be obtained prior to any screening procedures; if consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Patient must provide study specific informed consent prior to study entry
The patient must provide study-specific informed consent prior to study entry/screening
Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trial
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
PATIENT EXCLUSION: Unable to provide informed consent or complete study procedures as determined by clinical or study staff
CAREGIVER EXCLUSION: Unable to provide informed consent or complete study procedures as determined by clinical or study staff
102 Subject or subject's legally acceptable representative has provided informed consent/assent prior to initiation of any study-specific activities/procedures.
Signed and dated informed consent form (by the patient or a legally acceptable representative as per the local regulations) obtained prior to initiation of any study-specific procedure and treatment.
Have signed an informed consent document indicating that the subjects understand the purpose of and procedures required for the study and are willing to participate in the study
Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
Patient must provide study specific informed consent prior to study entry.
Written informed consent must be obtained prior to any procedures
Able to give informed consent, and comply with study procedures
Severe cognitive dysfunction impairing ability to provide informed consent or consume study drug
All patients must be informed of the investigational nature of this study and must sign a study specific informed consent in accordance with institutional and federal guidelines prior to study entry
In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment
In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment
Provides consent for his/her own treatment and procedures
Consent to the study; and
Informed consent must be obtained prior to any study-related procedures; consent will be obtained from a parent or guardian of eligible subjects, or the patient if >= 18 years old; oral assent will be obtained from minor subjects >= 7 years old, unless more stringent requirements are imposed by a site’s local institutional review board
With sufficient ability to communicate in English in order to provide informed consent and complete study procedures and materials
Patient must be informed of the investigational nature of this study in accordance with institutional and federal guidelines and have the ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the study
Subject must sign a study specific informed consent prior to study entry
Significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits the patient’s ability to participate in the informed consent procedures
Written informed consent prior to any study-related procedures
Patients must provide study specific informed consent prior to study entry
Provision of informed consent prior to any study-related procedures
Patients must sign a study-specific informed consent prior to study entry
Patients must provide study-specific informed consent prior to registration
Have an understanding of study procedures
Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to any study specific procedures
Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed
Each subject must sign an informed consent form indicating that he or she understand the purpose of and procedures required for the study and are willing to participate
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Patient is unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations; a legal representative can consent on behalf of a patient who is able to understand the purpose and risk of the study but not able to provide a signature on the ICF and authorization to use PHI due to neurologic deficits (e.g. motor or language deficits)
Patients must provide study specific informed consent prior to study entry
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures
Ability to understand and the willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures
Written informed consent before any study-specific procedure is performed
Written informed consent prior to any study-related procedures
Subjects must give written informed consent to participate in study. Consent must be obtained prior to the performance of any study-specific, non-institutional standard procedures. A copy of the signed informed consent will be retained in the subject's chart.
Patients must provide study-specific informed consent prior to study entry
Before any study-specific procedure, the appropriate written informed consent must be obtained from the subject or a legally accepted representative.
Patients must sign an informed consent before data collection, screening, or initiation of study procedures
Provide signed informed consent and agree to comply with all protocol-specified procedures (e.g., providing saliva samples; participating in five one-hour group sessions over a period of 22 days) and follow-up evaluations
Subject capable of providing written informed consent prior to initiation of any study procedures; subjects able to understand and comply with planned study procedures and be available for all study visits
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Individuals who have the ability to understand and willingness to sign an informed consent before initiation of study procedures, after the nature of the study is explained to them and they have asked any questions
Provide informed consent and agree to all assessments and study procedures.
Voluntary written consent prior to the performance of any research related procedures
Provide informed consent and agree to all assessments and study procedures
Provide informed consent and agree to all assessments and study procedures
Participant is able and willing to comply with study procedures, and signed and dated informed consent is obtained
Understand and voluntarily sign an informed consent document prior to any study-related assessments or procedures conducted.
Understand and voluntarily sign a biomarker-specific component of the informed consent document prior to any study-related procedures conducted.
Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
Provision of written informed consent and assent, when applicable, for tumor resection, stereotactic surgery, tumor biopsy, sample collection, and/or treatment with study drug prior to undergoing any study-specific procedures
Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Documented, signed, dated informed consent obtained prior to any study specific procedures being performed
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
SPECIFIC TO STUDY PART #1
SPECIFIC TO STUDY PART #2
Patient must sign study-specific informed consent prior to study entry
Patients who in the judgment of the investigators and/or consenting professional, are able to understand the purpose of the study and provide informed consent will be included
Subject must provide written informed consent prior to any study-related procedures being performed
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures
Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures
The subject is able and willing to comply with study procedures and provide signed and dated informed consent
The subject is able and willing to comply with study procedures and provide signed and dated informed consent
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures
Unwilling or unable to provide informed consent; only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study; individuals who are considered to be mentally disabled will not be recruited for this study; all subjects must understand and be able to give informed consent; we will not be using specific methods to assess decisional capacity; economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation; all individuals will be told that their choice regarding study participation will in no way change their access to clinical care; this should negate any undue influence or coercion; children, fetuses, neonates, or prisoners\r\nare not included in this research study; the menopausal status of the study participant will be reviewed during the screening process by examining the patient’s chart, women of childbearing potential will have a serum or urine pregnancy test at the time of screening
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures
Patient or the patient’s legally authorized representative must provide written informed consent prior to registration and any study-related procedures
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures
The subject is able and willing to comply with study procedures and provide signed and dated informed consent
Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures
Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures
INCLUSION CRITERIA (NEXT 60 PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER): Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures
Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures
Provision of informed consent prior to any study-related procedures
Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up; procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol \r\n* Note: it is not necessary that informed consent be obtained within the protocol specified screening window
The subject's parent(s)/legal guardian(s) understand(s) and voluntarily signed an informed consent document prior to any study-related assessments/procedures being conducted. Where locally applicable, the subject also understands and voluntarily provides his/her assent prior to any study-related assessments/procedures being conducted
Patient must sign study-specific informed consent prior to study entry
Subjects able to provide informed consent and agree to comply with study procedures
Women competent to sign study specific written informed consent
Patient, or the patient’s legally acceptable representative, must provide a signed and dated written informed consent prior to registration and any study-related procedures
Patient must provide written authorization to allow the use and disclosure of their protected health information; NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration
Patients competent to sign study specific informed consent
Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent.
The subject must sign a written informed consent form prior to the initiation of any study procedures. Adult subjects unable to provide written informed consent on their own behalf will not be eligible for the study.
Unwilling or unable to participate in all required study evaluations and procedures; unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Willing to and capable of providing written informed consent prior to any study related procedures
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
Valid written informed consent signed by the patient prior to any study-specific procedures
Ability to give informed consent and to comply with study procedures
The subject is able and willing to comply with study procedures and provide signed and dated informed consent
has the ability to read, understand and provide written informed consent for the initiation of any study related procedures (or legal representative)
Psychiatric or addictive disorders that impair subject’s voluntary ability to participate in informed consent or protocol procedures
Subject must sign a study specific informed consent prior to study entry
Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
Subject or his or her legal representative has the ability to read, understand and provide written informed consent for the initiation of any study related procedures
Patient or the patient’s legally acceptable representative must provide written informed consent prior to registration and any study-related procedures
Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
Provide written informed consent prior to any study-specific screening procedures
BIODISTRIBUTION COHORT: Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures
DYNAMIC COHORT: Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures
Provision of signed and dated written informed consent prior to any study specific procedures, sampling analysis
Has voluntarily consented to participate and provided written informed consent prior to any protocol-specific procedures
Ability to understand the investigational nature of the study and provide informed consent
The patient must have capacity to be able to sign a study-specific informed consent prior to study entry
Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
Patient must provide study specific informed consent prior to study entry
Patients who have provided informed consent for the long term follow up study prior to their study participation .
Understand and provide written informed consent prior to initiation of any study-specific procedures.
Written informed consent must be obtained prior to any baseline/screening procedures.
Written informed consent obtained prior any study-specific procedure (patient or parent(s) or legal representative)
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
Ability to understand purpose and risks of the study and provide signed and dated informed consent, and authorization to use protected health information
Signed and dated informed consent document obtained prior to initiation of any study-specific procedure and treatment (by the subject or a legally acceptable representative as per the local regulations).
Subject must understand and voluntarily sign an ICD prior to any study-related assessments/procedures being conducted.
Subject's legally acceptable representative has provided informed consent/assent when the subject is legally too young to provide informed consent/assent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
Ability to understand and the willingness to sign a written informed consent. A signed informed consent, including consent for biomarker analyses, must be obtained prior to any study-specific procedures
Willingness and ability to consent for self to participate in study