Submitting a Study for Amendment Review
BEFORE YOU BEGIN
- The Study Chair submits the study amendment to the Cancer Therapy Evaluation Program (CTEP) or Division of Cancer Prevention (DCP) for scientific review. Once approved by CTEP or DCP, an Approval on Hold (AOH) Letter is emailed to the Study Chair and the CIRB.
- After receiving the AOH Letter, the CIRB emails the Study Chair the CIRB amendment application, and the submission deadline for the next CIRB meeting. You can also download a copy of the CIRB Amendment Review Application and the Waiver of Consent Request Supplemental Form, if required.
STUDY CHAIR SUBMITS APPLICATION
The Study Chair emails the CIRB application to the CIRB by the submission deadline, 14 days before the scheduled CIRB meeting. Complete submission includes: CIRB application, protocol, model consent form, and, as applicable, Investigator's Brochure, recruitment material, and patient reported outcomes.
CIRB REVIEWS SUBMISSION
The CIRB Operations Office determines if the amendment review qualifies for expedited review or if it requires full board review. Expedited reviews are sent to the CIRB Chair and full board reviews are reviewed at a convened meeting.
CIRB SENDS STUDY CHAIR AN OUTCOME LETTER
Within seven days of meeting, the CIRB emails the Study Chair an outcome letter summarizing the board’s determination. Possible outcomes are: Approval, Approved Pending Modifications or Tabled.
CIRB REVIEWS STUDY CHAIR’S RESPONSE
The CIRB reviews the Study Chair’s response either by expedited review or convened CIRB review. If convened CIRB review is required, the submission will be reviewed at the next CIRB meeting and an approval will be issued or additional modifications will be required. If additional modifications are required, the process repeats at step 3.
CIRB ISSUES APPROVAL
Following approval, the CIRB issues an Approval Letter to the Study Chair within two days of the determination.