Clinical trials & research: FDA inspection preparation

Prepare for a clinical research inspection by defining the study, the inspected party, the applicable requirements, and who controls each record. This work differs from manufacturing-site preparation and from the role of an FDA field investigator.

Connect site, sponsor, and vendor records

Map record locations and authorized access, responsibilities for retrieval and explanation, and how changes are retained. Practice with permitted training records. Do not expose unrelated participant information or assume a vendor holds a version without checking.

Use official inspection context

FDA’s Processes and Practices Applicable to Bioresearch Monitoring Inspections guidance, issued December 2025, provides relevant source context. Assess its scope for your activity and read the complete current document.

Learn in focused steps

Clinical research learning hub · Short guides · In the Warroom: clinical research edition · Clinical trial webinar interest · All proposed programs

Request a scoped inspection-preparation discussion. Scope, availability, and expertise are agreed for the actual project; no inspection outcome is promised.