Update to CIRB Instructions for Study Chair Response’s Content and Format
Dear CIRB Stakeholders,
The CIRB Operations Office has updated the Study Chair Response (SCR) instructions to provide additional clarity regarding formatting requirements when submitting a SCR to the CIRB. These changes were made in collaboration with the CTEP and DCP Protocol Information Office (PIO).
These instructions should be followed when preparing and submitting revised documents in response to a CIRB determination of Approval Pending Modification (APM) or Tabled. The purpose is to provide a tool to promote consistency in both the content and formatting of SCR submissions to the CIRB.
Primary changes to the document include changes required in the change memos as well as updating specific requirements for formatting which may vary between the CTEP and DCP PIOs.
The Study Chair Response instructions are available on the CIRB website and are also provided in each of the CIRB’s APM or Tabling outcome emails along with the official outcome letter.
In addition to updating the content of the SCR Instructions, the CIRB is now providing sample Change Memos on the CIRB website as a tool for the sites to utilize when developing a SCR.
Please contact the appropriate CIRB Central Inbox with any questions:
- Adult CIRB – Early Phase Emphasis
- Adult CIRB – Late Phase Emphasis
- Cancer Prevention and Control CIRB
- Pediatric CIRB
NCI CIRB Operations Office