INSTRUCTIONS: Study Renewal/Continuation Form

• Note: If a renewal application is not approved by the CPHS expiration date, all human subjects research activity on this protocol must cease. The Lead Investigator is responsible for ensuring that renewal applications are submitted at least six weeks prior to the study expiration date to allow adequate time for review and re-approval.

• Complete points 1 through 9 to provide information regarding study status and a summary of study findings from the past year.

• If “yes” to any questions under point 10, Proposed Study Amendments, complete and attach the CPHS Study Amendment Form as appropriate. (If amendment of the protocol, consent documents, or study instruments is involved, the request will need to include two copies incorporating the proposed revisions, one copy with changes highlighted.)