CIRB Requirements for Study Chair Response Content and Format
Dear CIRB Stakeholders,
The CIRB Operations Office is now providing a set of instructions for use by Study Chairs when preparing and submitting revised documents in response to a board determination of Approval Pending Modification (APM) or Tabled. The purpose of the new instructions is to ensure consistency in both the content and formatting of Study Chair Responses (SCR). These new instructions will be made available via a weblink which will be included in each APM or Tabling email along with the CIRB’s outcome letter. The Study Chair Response instructions are also available on the CIRB website.
Specifically, please note the following:
- Change Memos and tracked changes must be cumulative to inform the Protocol Information Office (PIO) of all the changes upon final approval from the CIRB. Maintain the Change Memos and tracked changes that were included in the initial submission to the CIRB from PIO to ensure they are cumulative.
- Include ONLY changes related to the CIRB stipulations. Studies managed by CTEP PIO with additional changes will require a new review and approval from CTEP PIO prior to CIRB review and will result in a review delay which is highly discouraged. For DCP PIO managed studies, DCP PIO does not allow any changes other than those requested by the CIRB.
Please contact the appropriate CIRB Central Inbox with any questions: