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 might affect the willingness of subjects 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 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.
- In the RNI form, there are 3 options you can choose from that would be relevant to your assessment of the IND safety report: Unanticipated Problem, New Information, or IND safety report (that does not meet the description of new information or unanticipated problem). Select one of these options based on the assessment of the PI.
- The RNI form is event specific. You may use one RNI form to submit an IND safety report that is relevant to multiple protocols, if the assessment is the same across all protocols. You may also use one RNI form to submit multiple IND safety reports that pertain to the same event.
- If your protocol is overseen by a non-NIH IRB, you do not need to submit the IND safety report via RNI per NIH Policy 801, unless the report relates to an event that occurred at an NIH site, or directly impacts the NIH site.
Even though all IND safety reports must be submitted, investigators are still responsible for evaluating how the information affects their study and participants.
Key Takeaway
When NIH is the Reviewing IRB, all IND safety reports received from a sponsor must be submitted to the IRB within 7 calendar days via RNI submission.
Investigators remain responsible for reviewing each report, determining its impact on their study, and taking appropriate action to protect participants.