Documentation of Informed Consent Study Title: ___________________________________________________________ ______________________________, ___________________, was evaluated for Patient Name MR Number or Study ID # participation in protocol # _____________. Prior to signing the informed consent form, the purpose, procedures, risks, and benefits of the trial were explained and ample time was given for consideration. Alternatives to participation in the protocol were outlined and the patient/legally authorized representative was given the opportunity to ask questions, which were satisfactorily answered. The patient/legally authorized representative signed consent on ____/_____/________ Month Day Year at ______ AM/PM and was given a signed copy of the consent for his/her files. Consent was signed prior to starting any protocol treatment or procedure. The patient/legal authorized representative agrees to comply with the requirements of the study. Eligibility will be determined after completion of protocol screening requirements. The patient/legal authorized representative was informed of the unknown risks to an unborn child and advised of reliable birth control methods that are acceptable for the study requirements to prevent pregnancy or impregnating a partner while on study. □ Yes □ No □ N/A Notes: __________________________________________________________________ Signature of Consenter: _______________________________ Date: _______________ For questions regarding the study, contact the Principal Investigator,______________, at (___)__________.