Beginner’s Guide to IND Safety Reporting Under 21 CFR 312(c)

At the core of clinical research, the safety of all stakeholders is paramount. To guide the safe and ethical execution of research, the U.S. Food and Drug Administration (FDA) oversees extensive regulations supported by pharmacovigilance teams. Although necessary, complex safety regulations can not only be difficult to understand but also challenging to implement across your research operations. This blog outlines IND safety reporting required under FDA 21 CFR 312.32(c), challenges faced in adhering to the regulation, and strategies to ensure compliance across your research program.

What is FDA 21 CFR 312.32(c), IND Safety Reporting?

Broadly, FDA 21 CFR 312.32(c) outlines detailed requirements for sponsors to communicate potentially serious risks of an Investigational New Drug (IND) to participating principal investigators. In detail, under 21 CFR 312.32(c), the sponsor is required to notify all participating investigators in an IND safety report (i.e., 7- or 15-day expedited report) of potentially serious risks from clinical trials or any other source as soon as possible, but no later than 15 calendar days after the sponsor receives the safety information and determines that the information qualifies for reporting. Participating investigators include all investigators to whom the sponsor is providing a study drug or under any investigator’s IND (21 CFR 312.32(c)(1)). This includes all investigators participating in clinical trials under an IND, at U.S. and non-U.S. sites, for the investigational drug, and any investigators conducting a study under their own IND for whom the sponsor provides the investigational drug.

The FDA recently drafted new guidance to help sponsors comply with expedited safety reporting requirements. Subscribe to receive resources on major regulatory updates.

The Considerations of IND Safety Reporting

Sponsors are responsible for communicating and tracking IND safety reporting. As sponsors, what should you consider when ensuring necessary measures are in place to remain compliant? Especially with increasingly complex studies conducted across a global footprint, this question becomes even more essential yet difficult to execute. When establishing processes to support compliance or exploring technologies to assist your communication, consider these elements:

• How quickly is your study team alerted to serious risks in your clinical trials?
• How does your study team evaluate serious risk and determine the information qualifies for reporting?
• How does your study team compile the safety report, and how quickly and confidently can it be distributed to all your participating investigators?
• How do you record, track, or prove that the report was distributed?
• Where do you store receipt of the report?
• Where can you minimize redundant or duplicate effort across all participating investigators and multi-study programs?
• In what ways can you utilize other systems your team uses to execute IND safety reporting?

When establishing or evaluating safety reporting processes, consider the questions above to ensure your safety reporting strategy is compliant, reliable, and efficient.

Technology to Support IND Safety Reporting

To confidently ensure compliant and efficient safety reporting, it is best to implement a centralized approach that leverages pre-existing communication channels with investigators, Part 11-compliant signatures, and document storage. Systems like Advarra’s Longboat Platform, which already has an established line of communication with investigators and monitoring, ensure a tested and compliant process for dissemination, tracking, and reporting of IND safety letters.

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