What is it? Why is it important?

Once the study is finalised, a study site can still be:

  • Audited by the SP-INV
  • Inspected by Swissmedic
  • Reviewed by EC

Inspections can occur even after the study has ended and all its documents have been archived.

Reasons for a post-audit or a post-inspection include:

  • A re-evaluation of the study data (e.g. open questions remain, suspicion of study misconduct, IMP registration)
  • A re-evaluation of the study safety data (e.g. needed for the Clinical Study Report (CSR) or additional requests from EC and/or Swissmedic)

What do I need to do?

As a SP-INV and Site-INV:

  • Ensure to archive the study so that all documents are readily available for a post-inspection or post-audit
  • In the event of a post-inspection or post-audit, follow the same procedures as would be expected during an audit or inspection during study conduct

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

Declaration of Helsinki – see in particular principle

  • 34 Post-Trial Provisions
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CSR – Clinical Study Report
  • CTU – Clinical Trials Unit
  • EC / RA – Ethics Committee / Regulatory Authorities
  • IMP – Investigational Medicinal Product
  • SP-INV – Sponsor Investigator
Completion ↦ Ethics and Laws ↦ Inspections and Audits ↦ Procedures
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): Completion ↦ Ethics and Laws ↦ Inspections and Audits ↦ Procedures

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