OVERVIEW
This Quickguide provides instructions to Study Chairs/Coordinating Centers for submitting Recruitment/Participant Materials for review. Recruitment/Particitpant materials may include, but are not limited to, the following:
- Recruitment Material
- Brochures
- Posters or Flyers
- Videos
- Participant Facing Materials
BEFORE YOU BEGIN
- Cancer Therapy and Evaluation Program (CTEP) studies: The Study Chair/Coordinating Center emails the appropriate CIRB requesting a submission of recruitment materials. The CIRB will send a notification email and link to the online CIRB Amendment Review Application in IRBManager.
- Division of Cancer Prevention (DCP) studies: the materials must be submitted to the DCP Protocol Information Office (PIO) for an Approval On Hold (AOH). After receiving the AOH Letter, the CIRB will send a notification email and link to the online Amendment Review Application in IRBManager.
- Recruitment Videos: Submission of draft materials and/or scripts for videos to the CIRB for approval prior to initiating video production is required since changes stipulated by the CIRB could be costly to make after production. A final version of the video must be submitted to the CIRB for review and approval by using the online CIRB Participant Recruitment Materials Final Video Submission Form. Here is sample word version - CIRB Participant Recruitment Materials Final Video Submission Form.
STEPS
COORDINATING CENTER SUBMITS APPLICATION
The Coordinating Center completes the Amendment Review Application via IRBManager and submits it to the CIRB along with all draft recruitment/participant materials to be reviewed. Complete submission includes: CIRB Amendment Review Application and draft recruitment/participant materials.
The Coordinating Center should contact the designated CIRB Committee directly with questions about the application process.
- Adult CIRB- Late Phase Emphasis: adultcirb@emmes.com
- Adult CIRB- Early Phase Emphasis: earlyphasecirb@emmes.com
- Cancer Prevention and Control CIRB: CPCCIRB@emmes.com
- Pediatric CIRB: pediatriccirb@emmes.com
CIRB REVIEWS SUBMISSION
The CIRB Operations Office determines if the material qualifies for expedited review or if it requires full board review. Expedited reviews are sent to the CIRB Chair or Vice Chair and full board reviews are reviewed at a convened meeting.
CIRB SENDS STUDY CHAIR/COORDINATING CENTER AN OUTCOME LETTER
The CIRB emails the Study Chair and Coordinating Center an outcome letter summarizing the board’s determination. Possible outcomes are: Approved, Approved Pending Modifications, Approved with Query or Tabled.
COORDINATING CENTER RESPONDS TO CIRB
If required, the Coordinating Center responds to the CIRB’s requests for study modifications or query by submitting the necessary revised documents within 14 days of the outcome letter date.
CIRB REVIEWS COORDINATING CENTER’S RESPONSE
The CIRB reviews the Coordinating Center’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
The CIRB issues an Approval Letter to the Study Chair and Coordinating Center within two days of the determination.
SUBMISSION OF FINAL VIDEO
After the CIRB has approved draft video materials and the final video is produced it must be submitted to the CIRB for approval via submission of the CIRB Participant Recruitment Materials Video Submission Form. This form which contains a link to the video location (e.g., Group website) will be posted on the CTSU web site and can be accessed as needed.
The final video receives a review by the CIRB and the CIRB emails the Study Chair an outcome letter summarizing the board’s determination. Possible outcomes are: Approved, Approved Pending Modifications, Approved with Query or Tabled.