Submitting a Study for Initial Review
This Quickguide provides Coordinating Centers with an overview of the Initial Review process.
BEFORE YOU BEGIN
- The Study Chair/Coordinating Center 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 notification and link to complete the online Initial Review Application in IRBManager to the Coordinating Center. A Word version of the CIRB Initial Review Application is also available, if required.
COORDINATING CENTER SUBMITS APPLICATION BY THE SUBMISSION DEADLINE
The Coordinating Center completes the application via IRBManager 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.
The Coordinating Center should contact the designated CIRB Committee directly with questions about the application process.
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 or Vice Chair for review.
CIRB SENDS STUDY CHAIR/COORDINATING CENTER AN OUTCOME LETTER
Within seven days following the CIRB meeting, the CIRB emails an outcome letter to the Study Chair and Coordinating Center. The possible outcomes are: Approved, Approved with Query, Approved Pending Modifications or Tabled. The letter states the board’s stipulations for changes to the protocol and/or query. If there are questions related to the stipulations, a conference call may be arranged to discuss.
COORDINATING CENTER RESPONDS TO CIRB
The Coordinating Center responds to the CIRB’s ,odifications and/or query by completing the application via IRBManager and submitting the necessary revised documents within 14 days. For more information please refer to the Study Chair Response instructions. A sample Change Memo is also available as a reference.
CIRB REVIEWS COORDINATING CENTER’S RESPONSE
The CIRB reviews the Coordinating Center’s response via expedited review procedures or convened CIRB review. If convened review is required, the submission will be reviewed at the next available 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 and Coordinating Center within two days of the approval determination.