Tuesday, March 9, 2010

Time Frames of SAE Reporting - Clinical Trials

SAE (Serious Adverse Event) Reporting is critical to patient safety and is required by FDA while a drug is under clinical research and development. SAE reporting and time frames are required by FDA and are reviewed and approved by an independent Investigational Review Board (IRB) for each clinical study protocol. SAE Reporting and agreed time frames must be in compliance with FDA patient safety guidelines and developed for each investigational drug, device, dosing regimen and therapeutic indication under study. For example -

  • Events occurring before taking study drug are not reportable unless related to study procedures.

Dosing during study:

  • All SAEs are reportable.

Post-dosing (regardless of the drug relationship):

  • All SAEs are reportable from the first dose of the study drug until 28 days following discontinuance of the study drug regardless of relationship to the drug.

Post-dosing (drug related):

  • All SAEs that are believed to be drug related must be reported regardless of time elapsed since the last study drug dose, even if the clinical trial is stopped or on clinical hold.

Pregnancy reporting:

  • Dosing during study/post-dosing - Pregnancy occurring in patients treated with the study drug or which occurs up to 90 days after the last dose of the study drug are reportable as SAEs.
  • Pregnancy occurring in the female partner of a male patient in a clinical trial whose last dose of study drug was within 90 days of conception is also reportable.

Expedited SAE reporting includes:

  • AEs which are serious and unexpected and classified as drug related qualify for expedited reporting to the FDA.
  • Information that may influence the benefit/risk assessment of a study drug or that would be sufficient to consider changes in the study drug regimen, administration or in the overall conduct of the clinical drug investigation and protocol design.

As always, early planning, early reporting is a must with SAEs.

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