INSTRUCTIONS: Study Amendment Form

• Note: No human subjects research activity proposed in the amendment request may proceed until CPHS approval is received. Investigators should submit Amendment requests at least four to six weeks prior to the time they wish to initiate study modifications to allow adequate time for review and approval.

• If the Amendment request is part of a Renewal/Continuation application, the CPHS Cover Sheet should include all information pertaining to both renewal and amendment(s) of the study.

• Complete points 1 through 8 to provide information regarding proposed amendments

• If amendment of the protocol, consent documents, and/or study instruments is involved, the request will need to include two copies of the relevant materials that incorporate the proposed revisions, one copy with changes highlighted.