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Acing an Audit

  • Cara East
Chapter

Abstract

The research study team may be notified about an impending audit by telephone or in writing. In turn, the research site should notify all involved parties, including the sponsor, CRO, and IRB. Sponsor audits are done to be certain that the site is collecting accurate information which may be crucial for FDA approval. IRB audits instead focus on subject safety, welfare, privacy, and confidentiality. An FDA audit can occur randomly or be triggered if the site is a top enrolling site, if the site is recommended to the FDA by the sponsor or CRO, if the site has had prior quality issues, or if there are public health issues concerning that research. An FDA audit, also called an inspection, follows very specific protocols of which the site should be informed. An audit is a time to hone the clinical research skills and appreciate the clarity that an audit can bring.

Keywords

Audit Inspection Form 482 For-cause audit Note to file Good clinical practice (GCP) NAI (no action indicated) VAI (voluntary action indicated) OAI (official action indicated) Form 483 

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Cara East
    • 1
  1. 1.Baylor Soltero CV ResearchBaylor University Medical CenterDallasUSA

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