A representative from a regulatory authority shows up unannounced at a research site.

Regulatory authorities have the legal right to inspect clinical trial records, including identifiable information, even if the study has been closed out. After verifying the inspector's credentials, the site personnel must grant access to all requested documents to ensure compliance with regulations.

According to GCP guidelines, regulatory authorities have the right to access trial-related documents and data during inspections.

"Investigators must grant access to study records when requested by regulatory authorities as part of their inspection rights."

Objectives:

Ensure compliance with inspection requirements.

Maintain transparency with regulatory authorities.