A regulatory inspection represents an official examination conducted by government authorities to verify compliance with laws, regulations, and standards governing clinical research. Unlike sponsor-conducted audits, inspections carry regulatory authority and may result in official findings that affect drug approvals, require mandatory corrective actions, or lead to enforcement proceedings. Regulatory agencies including the FDA, EMA, and national authorities worldwide have the power to conduct inspections at any time.

Inspections may be routine, scheduled as part of normal regulatory oversight, or may be triggered by specific concerns such as unusual data patterns, complaints, or safety signals. Pre-approval inspections typically occur before regulatory approval decisions and focus on verifying that submitted data accurately represents trial conduct. Post-approval inspections monitor ongoing compliance and may focus on marketed product trials or expanded access programs. For-cause inspections are initiated in response to specific concerns about potential non-compliance.

Preparation for inspections is an ongoing process, not a last-minute activity. Sites and sponsors must maintain complete, accurate, and accessible documentation throughout the trial to ensure readiness for inspection at any time. When an inspection is announced, the inspected party should ensure that key personnel are available, that requested documents can be provided promptly, and that appropriate workspace is available for inspectors. Following the inspection, official findings must be addressed through formal responses that describe corrective and preventive actions taken.