April 2016

What are the regulatory requirements for submitting Investigational New Drug (IND) safety reports?

The phrase “IND safety reports” originates in FDA regulations 21 CFR 312 – Investigational New Drug Application.  The regulations require that the sponsor of an IND (who may or may not be a study investigator) submit IND safety reports to the FDA and to participating investigators conducting studies involving the IND product.

IRBs are required by FDA and DHHS human subjects protection regulations to review “unanticipated problems involving risks to participants or others.”  IND safety reports do not necessarily meet the definition of an unanticipated problem.  Often, however, sponsors send IND safety reports to investigators and instruct the investigators to submit them to the IRB.  The IND safety reports concern a product under study and such reports may not necessarily apply to events that occurred in the protocol conducted at JHM. 

Is an investigator required to review IND safety reports?

Yes.  Investigators should review all IND safety reports sent by the sponsor.

When must a JHM PI submit IND safety reports to the JHM IRBs?

The JHM PI must submit IND safety reports to the JHM IRBs only in the following cases:

1. When the report meets the definition of an unanticipated problem (see Policy 103.6(b)); or,
2. When an IND safety report triggers a sponsor-required change to the research protocol or consent form; or
3. When the sponsor indicates the safety information must be reviewed by the IRB to determine that either a change in research is required or currently enrolled subjects should be informed of the new information.

How must a JHM PI submit IND safety reports to the JHM IRB?

If the report constitutes an unanticipated problem (item number 1 above), the PI must submit a Further Study Action for Protocol Event Report in eIRB, including a copy of the IND safety report.  

If the report falls under either item number 2 or item 3 above, the PI must submit a Further Study Action for Change in Research in eIRB and include a copy of the IND safety report.  

If the IND safety report does not represent an unanticipated problem or does not contain information that requires a change to the protocol or consent form, the report does not have to be submitted.  It should be kept by the investigator with the other regulatory documents provided by the sponsor.

If a sponsor requires submission of all IND safety reports to the JHM IRB, how should they be submitted?

If a sponsor requires submission of all IND safety reports to the JHM IRB, submit the information using the “Submit IND Safety Report” activity in eIRB.  The IND safety reports will be acknowledged but will not be reviewed by the JHM IRB.  The system will generate an automatic receipt and acknowledgment email.  The email acknowledgment is not confirmation of IRB review and approval of the IND safety reports.

After a study has been terminated, must a JHM PI submit IND Safety Reports to the JHM IRB?

No. Investigators do not submit IND Safety Reports received after a study has terminated.

The attached IND Safety Report Flow Chart outlines the reporting options explained above.