10/12/2021

The US Food and Drug Administration (FDA) released a draft guidance, “Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices” in September 2021. It combines recommendations from the 2009 procedural final guidance, “Adverse Event Reporting to IRBs - Improving Human Subject Protection” and the investigator responsibilities for adverse event reporting portion of the final guidance from 2012, “Safety Reporting Requirements for INDs and BA/BE Studies”. This draft guidance clarifies how investigators can comply with their regulatory safety reporting requirements and understand when safety data may show reportable issues including serious adverse events (SAEs) or unanticipated adverse device effect (UADE).

The draft recommendations for investigators to comply with their responsibilities include:

1) Investigational New Drug application (IND) studies and how to identify safety data that could signal an unanticipated problem (SAE) that might be a risk to study participants, therefore requiring prompt reporting to an IRB per regulatory requirements.

2) Investigational Device Exemption (IDE) studies and how to identify safety data that would trigger reporting an UADE to sponsors and IRBs per regulatory requirements.

Although the IND safety reporting requirements in 21 CFR 312.32 apply to sponsors, the FDA believes that it is important for investigators to understand the sponsor’s responsibilities to comply with their own responsibilities and to support the data needed by the sponsor. Sites work directly with study participants and are the key to identifying potential safety risks or issues.

Read our blog “FDA IND Safety Reporting: New Draft Guidance” for more information about the sponsor focused draft guidance. This “merged 2021 draft guidance” is a combination of the sponsor portion of the final guidance from 2012, “Safety Reporting Requirements for INDs and BA/BE Studies” and an updated version of the draft guidance from 2015, “Safety Assessment for IND Safety Reporting,” which was withdrawn due to concerns summarized in the referenced blog. Until both draft guidances become finalized, the 2012 and 2009 guidance documents remain in effect.

What are your thoughts on the draft guidance? Does it support sites in understanding their responsibilities? Submit comments HERE through November 29, 2021.

- The Clinical Pathways Team

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