What is it? Why is it important?

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. laboratory, pharmacy)

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

  • Suspicion of misconduct (e.g. non-compliance with the study protocol)
  • Mismanagement issues (e.g. poor handling of IMP/MD, biological material, delegation of staff responsibilities)
  • Findings during site monitoring (e.g. loss of data, protocol compliance issues, poor ISF filing)

More

The decision to conduct an audit is weighed against study risk criteria, such as the ongoing:

  • Safety of study participants
  • Quality of study data

High priority circumstances include:

  • Detected irregularities during study monitoring (e.g. non-compliance issues with the study protocol)
  • Higher risk studies (e.g. Swissmedic category B or C studies)
  • Inclusion of study participants (e.g. large recruitment numbers, vulnerable population)
  • Study type and complexity (e.g. multi-centre, blinded and randomised studies)
  • The risk level of the study (e.g. first-in-man, placebo controlled studies)

What do I need to do?

When preparing for an audit, the SP-INV:

  • Notifies the Site-INV of the upcoming audit
  • Provides the Site-INV with the purpose and scope of the audit
  • Selects independent auditors (e.g. independent from the study)
  • Prepares, in collaboration with auditors, an audit agenda and an audit plan (e.g. how to conduct the audit and its focus)
  • If applicable, requests site-specific documents for review, prior to the site audit

The Site-INV:

  • Prepares the study team
  • Reviews site documents to ensure they are complete, up to date, and correctly filed (e.g. ISF)
  • Reviews local processes to ensure they are properly implemented (e.g. IMP/MD handling, processing of biological material)
  • Reviews study training and responsibilities (e.g. Site-Delegation-Log)

For more information refer to QM and Risks in this Study Guide.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guidelines

  • 4.1.4 Investigator general
  • 4.9.7 Investigator records
  • 5.1.2 Sponsor general
  • 5.19 Audit
  • 5.20 Noncompliance
Abbreviations
  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISF – Investigator Site File
  • IMD – Investigational Medical Device
  • IMP/MD – Investigational Medicinal Product
  • QM – Quality Management
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Ethics and Laws ↦ Inspections and Audits ↦ Audit Conduct
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Ethics and Laws ↦ Inspections and Audits ↦ Audit Conduct

Please note: the Easy-GCS tool is currently under construction.