Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

In 2019, nearly a quarter of the FDA’s clinical trial inspections resulted in citations for noncompliance.

To avoid the same fate, you need to understand how the agency conducts inspections, know what issues commonly trip up other organizations and develop an inspection-readiness plan that closes any gaps before they are discovered. You need to know:

• How the FDA initiates an inspection


• What documents the agency will review


• How to respond to a Form 483


• Common causes of inspection observations (e.g., failure to follow the investigational plan; safety reporting failures; inadequate case report forms)


• Consequences of noncompliance

Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs brings together all the guidances, statistics and instructions you need to successfully get through an FDA inspection. In addition to explaining the inspection process under the FDA’s Bioresearch Monitoring Program (BIMO), which sets out a precise routine for each kind of inspection, the guide provides you with:

• The Compliance Program Guidance Manual (CPGM) documents the FDA uses to train its staff to conduct GCP inspections;


• Information sheets and guidances on such subjects as:
• Informed consent
• Investigator responsibilities for protecting trial participants
• Form 1572 - Statement of investigator
• Inspection of clinical investigators
• Inspection of IRBs


• The latest BIMO statistics that show trends in the FDA’s inspection program.

You’ll also learn about:

• Types of questions FDA investigators might ask


• The FDA’s inspection routine


• Financial conflict-of-interest rules


• Records IRBs are required to maintain


• Records principal investigators must maintain


• What sanctions the FDA can impose on noncompliant investigators

The Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs guideprovides you with all the resources you need to pass your next inspection with flying colors.

Who Will Benefit

• Clinical trial investigators
• Clinical trial site staff
• CRAs
• CRCs
• IRB management
• Regulatory compliance staff