What is CGIRBs policy for reporting IND Safety reports?
Copernicus Group IRB should be notified of an IND Safety Report within 5 business days. The regulations state that the Investigator is responsible for communicating directly with CGIRB; nonetheless, in some instances the investigator may allow the sponsor to submit IND safety reports directly to CGIRB (on the investigator’s behalf) to make the process more efficient for investigators and for CGIRB. Unless the sponsor has made arrangements to submit IND Safety reports on behalf of all sites for your study, you must forward copies of all IND Safety Reports to CGIRB. This ensures a timely review so that a risk assessment is made to determine if a change in the subject information and consent form document is needed. After this review all investigators receive a written notice acknowledging the review. Submit UnAnticipated Problems (UAP) including but not limited to SAEs, Protocol Deviations and IND Safety Reports to one of the following: UAP Email: uap@cgirb.
