Audit
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A systematic and independent examination of study related activities and documents to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedure (SOP)(s), Good Clinical Practice (GCP), and the applicable regulatory requirements. ICH E6 Guideline for GCP, 1.6 Audits are not done continuously the way that monitoring is performed during a study, but instead are compliance snapshots in time.
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