The term “IND safety report” is being used here to represent all types of external adverse events reports, including, but not limited to, IND safety reports, MedWatch reports, and safety updates.
One of the primary responsibilities of an independent institutional review board (IRB) is to monitor the safety and welfare of participants at research sites that are acting under its jurisdiction.
Only those IND safety reports that may, in the opinion of the sponsor/CRO/SMO or principal investigator, represent an unanticipated problem involving risks to subjects or others should be reported to Sterling IRB. Generally, an adverse event observed during the conduct of a study would be considered an unanticipated problem involving risk to subjects or others, and reported to the IRB, only if it were unexpected, related or possibly related to participation in the research, and serious.
The Office for Human Research Protections (OHRP) has composed a guidance for sponsors, principal investigators, and IRBs that can be used to determine which IND safety reports need to be submitted to the IRB.