Serious or Not, Notify FDA of All Trial Safety Events, Guidance States
Trial sponsors should notify the FDA about all adverse events brought to their attention by data monitoring committees (DMC), regardless of whether the safety issue is “serious” or not, according to new guidance.
The agency supports the additional reporting even though it runs counter to regulations. Sponsors are legally required only to expedite reports of DMC recommendations regarding serious adverse events (SAE) in clinical studies, the April 20 guidance notes.
The Office of Management and Budget is reviewing the guidance now under the Paperwork Reduction Act, and it should be published within the next few months if approved.
Complying with clinical trial regulations can be difficult for any devicemaker. FDAnews has a quick reference guide sure to help out in any clinical trial situation.
Effective Techniques for Monitoring Medical Devices in Clinical Trials will help you:
- Quickly distinguish between unanticipated adverse device effects (UADE), adverse events and procedural complications from operator error;
- Understand the relationship between good clinical practice (GCP) and the monitoring of your medical device trials;
- Accurately apply risk management principles to GCPs; and
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