What is it? Why is it important?

Once a study is completed it can still be:


An inspection or audit can be requested even though the study has ended, and all its documents have been archived.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. to clarify remaining open questions, suspicion of study misconduct, application for market approval)
  • A confirmation or re-evaluation of the study`s safety data (e.g. needed for the Clinical Study Report, due to requests issued by the Ethics Committee (EC), regulatory authorities such as Swissmedic)

What do I need to do?

As a SP-INV and Site-INV:

  • Ensure to archive study documents in such a manner that they 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 of an audit or inspection during study conduct


Where can I get help?

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


Declaration of Helsinki – see in particular principle

  • 34 Post-Trial Provisions
  • 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

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Completion ↦ Ethics and Laws ↦ Inspections and Audits ↦ Procedures

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