What is the policy for reporting IND Safety reports?
The IRB should be notified of an IND Safety Report within 10 working days. Per ICH Guidelines, in some instances the sponsor may choose to submit the IND safety reports directly to the IRB. Unless the sponsor has made arrangements to submit IND Safety reports on behalf of all sites for a study, each Investigator must forward copies of all IND Safety Reports to the IRB. This ensures a timely review so that a risk assessment is made to determine if a change in the informed consent document is needed. After this review all investigators receive a written notice acknowledging the review.
