FDA clarifies reporting of adverse events in clinical trials

By Nick Taylor

- Last updated on GMT

Related tags: Clinical trial, Fda

The FDA has issued a final rule and draft guidance that clarifies what clinical trial safety information must be submitted to the agency.

Implementation of the final rule expands the safety information that must be submitted within 15 days of an issue arising. The US Food and Drug Administration (FDA) believes the changes will expedite its review of critical safety information and better protect clinical trial participants.

In a final rule​ and accompanying draft guidance​ the FDA states sponsors must now report: findings from clinical or epidemiological studies that suggest a significant risk to trial participants; and serious suspected adverse reactions that occur at a rate higher than expected.

Serious adverse events that occur during bioavailability and generic bioequivalence studies must also be reported within 15 days of the issue arising. Unexpected fatal or life-threatening suspected adverse reactions must be reported to the FDA within seven calendar days.

Clarify and harmonise

Unnecessary reporting of perceived adverse events is a drain on resources for the FDA, investigators and institutional review boards (IRBs). Having recognised some common mistakes in reporting adverse events the FDA has clarified its position.

In its documentation the FDA addresses when a single event should be reported and when sponsors should wait until a number of similar events have occurred.

Unnecessary reports of individual serious adverse events include: experiences that were probably linked to the underlying disease; issues that commonly occur in the study population independent of drug exposure; and those that were study endpoints.

Finally, revisions to definitions and reporting standards have been made to make them more consistent with the International Conference on Harmonization (ICH) and World Health Organization (WHO). This ensures harmonised reporting of globally conducted clinical trials.

Related news

Show more

Related products

show more

Laboratory Solutions for COVID-19 Clinical Trials

Laboratory Solutions for COVID-19 Clinical Trials

Q2 Solutions | 10-Jun-2020 | Clinical Study

As a leading laboratory services organization for trials across the globe, we are proud to partner with clients to support COVID-19 clinical trials. Our...

Parents as Gatekeepers for Children with Cancer

Parents as Gatekeepers for Children with Cancer

PRA Health Sciences | 08-Jun-2020 | Technical / White Paper

The RACE for Children Act will require new drugs intended for adult cancer treatment to also be studied in pediatric cancers when the molecular target...

Related suppliers

Follow us


View more