IND Safety Reports
IND Safety Reports are communications from a sponsor that provide important safety information about an investigational drug. These reports may describe events that occurred at other study sites or in other studies using the same drug.
IND Safety Reports are communications from a sponsor that provide important safety information about an investigational drug. These reports may describe events that occurred at other study sites or in other studies using the same drug.
Even if the event did not occur in your study, it may still have implications for the safety of your participants.
Key Requirement
Per current FDA guidance, all IND safety reports must be submitted to the IRB.
FDA considers information that meets IND safety reporting criteria to be an unanticipated problem involving risk to participants or others. Therefore, investigators are required to submit these reports to the IRB under 21 CFR 312.66.
This requirement applies regardless of whether the investigator believes the report is relevant to their specific study.
What This Means for Investigators
When you receive an IND safety report from a sponsor:
- Review the report to determine whether it impacts your study and if the event could qualify as a potential unanticipated problem (UP) for your own study or as new information (NI) that may affect the rights, safety, or welfare of participants or their willingness to enroll or continue participation in the study.
- Assess whether any actions are needed, such as:
- Updating the consent form
- Modifying the protocol
- Informing participants
- Submit the IND safety report to the IRB via a Reportable New Information (RNI) submission within 7 calendar days in accordance with Policy 801. Include your assessment of whether the information impacts your study.
- Submit the actual IND safety report (e.g., MedWatch report or equivalent safety report), not just the sponsor's cover letter or notification that a safety report was issued.
- In the RNI form, select the option that best reflects your assessment:
- Unanticipated Problem
- New Information
- IND Safety Report (that does not meet the definition of New Information or an Unanticipated Problem)
- One RNI submission may be used for:
- A single IND safety report that affects multiple protocols in the same manner, or
- Multiple IND safety reports related to the same event.
If your protocol is overseen by a non-NIH IRB, you do not need to submit IND safety reports to the NIH IRB unless the report relates to an event that occurred at an NIH site or otherwise directly affects the NIH site.
In addition, if there are no longer any participants enrolled on the study (i.e. your study is in data analysis) at the NIH site, IND safety reports that do not constitute a UP or NI for the NIH site do not need to be submitted to the NIH IRB.
Even when a report does not require changes to the study, investigators remain responsible for reviewing all IND safety reports and determining whether additional actions are needed to protect participants.
Key Takeaway
When NIH is the reviewing IRB, investigators must submit all IND safety reports received from a sponsor to the IRB within 7 calendar days via an RNI submission, unless an exception described above applies.
Investigators remain responsible for reviewing each report, determining its impact on their study, and taking any actions necessary to protect participants and maintain compliance with IRB requirements.