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Audit SOP for Clinical Research by Jaime Hinojosa is a document available to read on EtoBox.

What is Audit SOP for Clinical Research about?

This standard operating procedure outlines the steps for preparing for, conducting, and following up on sponsor, CRO, or FDA audits of clinical research conducted at a site. It describes notifying staff of upcoming audits, reserving workspace and assembling required documentation for review, answering auditor questions during the audit, and documenting any observations or findings that need follow up after the audit is completed. The purpose is to ensure compliance with regulations and guidelines for clinic

Author

Jaime Hinojosa

Language

EN