What is it? Why is it important?

Corrective and Preventive Actions (CAPA) are adaptations and improvements taken to eliminate causes of non-compliance. CAPAs includes a set of actions that require:

  • A root-cause analysis of the situation or the event
  • The implementation of corrective actions that allows for a non-compliant activity to return to compliance
  • The implementation of preventive actions with the aim to avoid the reoccurrence of the non-compliant event


After an audit or inspection, the SP-INV writes a CAPA plan that lists a response on how to handle non-compliance (findings) noted during the audit or inspection.

What do I need to do?

As a SP-INV:

  • Analyse findings listed in the audit / inspection report
  • Define CAPAs for each listed finding
  • Write a CAPA report to be forwarded to the audit or inspection team for approval. Include a timeline stating until when CAPAs will be implemented
  • Upon approval by the audit/inspection team, implement the CAPA plan within defined timelines
  • As applicable, update the RAF
  • In the event of a re-audit or re-inspection, the implementation of a previously approved CAPA plan can be re-evaluated


SP-INV Audits

SP-INV can audit participating study sites. Procedures are as described for regulatory inspections. Based on findings, the Site-INV writes a CAPA report including timelines. The SP-INV approve the CAPAs and supervises its implementation. Upon completion the Site-INV receives an audit certificate to be filed in the ISF.


Where can I get help?

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


ICH GCP E6(R2) – see in particular guidelines

  • 1.29 Inspection
  • 1.6 Audit
  • 5.0 Quality management

ISO 9001 – see in particular section

  • QMS Requirements (access liable to costs)
  • ISO 19011 – see in particular section
  • Guidelines for auditing management systems (access liable to costs)

EMA – Classification and analysis of GCP inspection findings


  • CAPA – Corrective and Preventive Actions
  • CTU – Clinical Trials Unit
  • EMA – European Medicine Agency
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • RAF - Risk Assessment Form
  • Site-INV - Site-Investigator
  • SP-INV – Sponsor-Investigator
Conduct ↦ Quality and Risk ↦ Regulatory Inspections ↦ Corrective and Preventive Actions

Provides some background knowledge and basic definitions

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

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

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

Starts with ethics and regulatory approval

Ends after successful study initiation

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

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

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 ↦ Quality and Risk ↦ Regulatory Inspections ↦ Corrective and Preventive Actions

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