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.
Submitting IND Safety Reports
Sterling IRB requires investigators to promptly report all events that may constitute unanticipated problems involving risk to subjects or others and new or updated safety information relating to the study or study product. All IND safety reports that may represent an unanticipated problem involving risks to subjects or others must be submitted to Sterling IRB within 10 business days of receipt.
For multisite studies, Sterling requires the sponsor to submit IND safety reports that may represent an unanticipated problem involving risks to subjects or others on behalf of the investigators. Investigators should not submit any IND safety reports to Sterling if reports are being submitted on their behalf.
For single-site studies, it is the principal investigator’s responsibility to submit all IND safety reports that may represent an unanticipated problem involving risks to subjects or others.