Your Easy Guide to Clinical Studies

An audit is a systematic examination of study activities conducted by the SP-INV to verify study compliance.

 

The SP-INV can perform an audit at:

• A participating study site
• A study partner or service provider (e.g. data management, statistic, laboratory, laboratory, pharmacy)

 

The SP-INV can initiate an audit at a study site based on:

• Mismanagement issues and poor study oversight (e.g. poor handling of IMP / IMD and Biological Material, staff training and responsibilities)
• Findings during site monitoring (e.g. loss of data, protocol compliance issues, poor ISF filing)
• Suspicion of misconduct (e.g. non-compliance with the study protocol)

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When preparing for an audit, the SP-INV:

• Notifies the Site-INV/partner/service provider of the upcoming audit
• Provides the auditee with the purpose and scope of the audit
• Selects independent auditors (i.e. independent from the study or service) to perform the audit
• Prepares, in collaboration with auditors, an audit agenda and an audit plan (i.e. audit focus and how to conduct the audit)
• If applicable, requests documents for review, prior to the audit

 

In the event of a site audit, the Site-INV:

• Prepares the study team
• Reviews site documents / quality processes to ensure they are complete, up to date, and correctly filed (e.g.study essential documents, ISF)
• Reviews local quality processes to ensure they are properly implemented (e.g. handling IMP / IMD and Biological Material)
• Reviews study training and responsibilities (e.g. Site-Delegation-Log)

References

ICH GCP E6(R3) – see in particular guidelines

• 2.3.5 Investigator responsibilities
• 2.12.14 Investigator records
• 2.3.5 Sponsor responsibilities
• 3.9 Sponsor Oversight
• 3.11.2 Audit
• 3.12 Noncompliance