Ability to understand and the willingness to sign a written informed consent document; NOTE: consent documents can be signed up to days prior to registration; if > days has elapsed since patient signed the consent document, s/he must re-consent (new signature) before proceeding to register onto study
Evidence of a personally signed informed consent document.
Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment
Signed informed consent document and assent when appropriate
Capability to understand and comply with the protocol requirements as and signed informed consent documents
Signed informed consent document(s)
Have signed an informed consent document
Signed informed consent document(s)
Patient has signed the informed consent document agreeing to the use of the study drug, domperidone
Signed written pre-registration informed consent document
ENROLLMENT: Signed informed consent and if applicable pediatric assent.
Signed informed consent document
Patient has the ability and willingness to provide informed consent and has signed the informed consent document
Signed informed consent document
Signed informed consent document and assent when appropriate
Signed informed consent prior to the start of systemic therapy; in the event of enrollment of a minor patient, an attempt to obtain assent from the patient must be documented, and parental consent must be signed
A signed informed consent document (ICD)
Signed informed consent document
The subject has the capability of understanding the informed consent document and has signed the informed consent document
Able to understand and comply with the protocol requirements and has signed the informed consent document.
Signed document of assent obtained if child >= years of age