Module 5 Presentations

05/07/2024

Audit (ICH GCP § 5.19)

A systematic and independent examination of trial related activities and documents to determine whether evaluated trial activities were conducted and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standards operating procedures, GCP and the applicable regulatory requirements.”

The Organisation for Professionals in Regulatory Affairs

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Auditing versus Monitoring

• Monitoring

Routine activity

•

• Carried-out by a member of the clinical team

• Equivalent to QUALITY CONTROL step

• Auditing

• Only done for a sample of sites / studies

• Auditors independent of the clinical team

• Part of sponsor’s QUALITY ASSURANCE activities

The Organisation for Professionals in Regulatory Affairs

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