Audit is a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analysed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practices (GCP), and the applicable regulatory requirements. Investigator sites, Sponsor, CRO, ERB are liable to get audited. The auditors are independent individuals appointed by sponsors/regulatory authorities to conduct a systematic and in-depth examination of trial conduct, and compliance with Protocol, SOPs, GCP, GLP, GPP and the applicable regulatory requirements. An audit is separate from routine Monitoring or quality control functions.

This topic describes: Investigational site audits, Clinical department process audits, Data management audits, Safety department audits, GCP laboratory audits and Sponsor central file audits.

Auditors Roles and Responsibilities

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