Submitting a Study for Initial Review
This Quickguide provides Study Chairs with an overview of the Initial Review process.
BEFORE YOU BEGIN
- The Study Chair submits the study to the Cancer Therapy Evaluation Program (CTEP) or Division of Cancer Prevention (DCP) for scientific review. Once reviewed, an Approval on Hold (AOH) Letter is emailed to the Study Chair and the CIRB.
- After receiving the AOH Letter, the CIRB emails the CIRB initial review application and submission deadline to the Study Chair. You can also download a copy of the CIRB Initial Review Application and the Waiver of Consent Request Supplemental Form, if required.
CHAIR SUBMITS APPLICATION BY THE SUBMISSION DEADLINE
The Study Chair emails the CIRB application to the CIRB by the submission deadline, 14 days before the scheduled CIRB meeting. The completed 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 reviews the complete submission at a scheduled meeting. On rare occasions, a study qualifies for expedited initial review per the regulations. Expedited reviews are sent to the CIRB Chair for review.
CIRB SENDS STUDY CHAIR AN OUTCOME LETTER
Within seven days following the CIRB meeting, the CIRB emails an outcome letter to the Study Chair. The possible outcomes are: Approved Pending Modifications or Tabled. The letter states the board’s stipulations and recommendations for changes to the protocol. If there are questions related to the stipulations, a conference call may be arranged to discuss.
STUDY CHAIR RESPONDS TO CIRB
The Study Chair responds to the CIRB’s recommendations for study modifications by submitting the necessary revised documents within 14 days.
CIRB REVIEWS STUDY CHAIR’S RESPONSE
The CIRB reviews the Study Chair’s response via expedited review procedures or convened CIRB review. If convened review is required, the submission will be reviewed at the next CIRB meeting. At that point, 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
The CIRB issues an Approval Letter to the Study Chair within two days of the approval determination.