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 (___)__________.