Sign up to receive these free articles weekly

No. 8: June 28-July 2, 2010

Question: Who is responsible for an IND annual report?

Scenario: Dr. Rogers is the sponsor of an Investigational New Drug (IND) for a marketed drug to treat a disease for which the drug was not approved. The disease is one that could place the patient population at increased risk.

As the anniversary of the effective date of the IND approaches, Dr. Rogers is reminded by the regulatory affairs support function in the clinical research office that the IND annual report is due. Dr. Rogers had completed his study last year and submitted the final report for that study to the Food and Drug Administration (FDA).

The IND remains active because a research fellow wants to modify the protocol and continue to study the drug for the same disease. This modified protocol was reviewed and approved by the Institutional Review Board (IRB) and submitted to the FDA under Dr. Rogers’ IND.

Issue: An IND annual report is due as long as the IND is active. If the study has not started because it has not been funded, or the study is complete and there is no further activity under that IND, the FDA still requires an annual report.

Solution: IND annual reports are the responsibility of the IND sponsor — in this case Dr. Rogers. The research fellow should write the report, and Dr. Rogers should submit it to the FDA.

Lesson Learned: An IND sponsor-investigator such as Dr. Rogers must understand his regulatory obligations. In this case Dr. Rogers must comply with both the regulations for an IND sponsor as well as the regulations for an investigator.

Pertinent Rule/Regulation: The Code of Federal Regulations describes IND responsibilities for sponsors and investigators [21 CFR 312]. Specifically, the annual report requirements are in 21 CFR 312.33.

Comments by Harvey M. Arbit, PharmD, MBA, the president of Arbit Consulting, LLC. He specializes in FDA regulatory affairs related to investigator-initiated IND and IDE research.

Agree? Disagree? Submit your comments