IND Safety Report Submission Guidelines

* 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.

1. General Information

One of the primary responsibilities of an Institutional Review Board (IRB) is to monitor the safety and welfare of participants at research sites that are acting under its jurisdiction. In recent years, especially in the case of larger multi-center studies, the reporting of adverse events that are external to an IRB's jurisdiction (e.g., IND Safety Reports) has begun to outweigh the reporting of internal adverse events (i.e., those taking place at the sites acting under the IRB's jurisdiction).

While the Sponsor is required to collect all IND Safety Reports for a given protocol, only a small subset of those reports should be submitted to the IRB. 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 human subjects, and reported to the IRB, only if it were unexpected, related or possibly related to participation in the research, and serious.

The excess reporting of IND Safety Reports to the IRB has the potential to limit the IRB's ability to adequately monitor the safety and welfare of participants at sites that are acting under its jurisdiction. 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.

2. 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 multi-site studies, Sterling acknowledges that the Sponsor is in a better position to process and analyze the significance of adverse event information from multiple sites and to make a determination about whether an adverse event is an unanticipated problem. Accordingly, Sterling requires the Sponsor to submit IND Safety Reports 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.

3. Acknowledgement of IND Safety Reports

Acknowledgements for submitted IND Safety Reports will typically be sent out on a semi-monthly basis.

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