What is it? Why is it important?

An audit is resolved once the SP-INV (or auditing part) approves the CAPA report suggested by the auditee.

The auditee (e.g. Site-INV) can request from the auditors an audit certificate, which includes:

  • The name of the site
  • The name of the audited study
  • The product under investigation (e.g. IMP chemical name)
  • Date of the audit
  • Main content of the audit
  • Name and title of auditors
  • Name and workplace of the auditee

During an inspection, Swissmedic or other relevant RAs (e.g. FDA, EMA) may request access to an audit certificate.

What do I need to do?

As SP-INV:

  • Review the audit report and CAPAs proposed by the auditee (e.g. Site-INV)
  • Decide whether proposed CAPAs are sufficient to correct and prevent the re-occurrence of findings that were established during the audit
  • Upon agreement and accepting the CAPA report, ask auditors to prepare an audit certificate
  • Sign and date the audit certificate
  • The timely implementation of suggested CAPAs can be re-assessed during a post-audit

As a Site-INV:

  • If necessary, request an audit certificate from the SP-INV
  • File the audit report and the audit certificate in the ISF
  • Ensure all CAPAs are implemented within the suggested timeline

More

A SP-INV can repeat an audit for any reason.

The decision to re-conduct an audit should be balanced against:

  • The relevancy of detected finding(s) from a previous audit
  • The submission requirements of the study (e.g. Swissmedic for category B or C studies)
  • Number of participants
  • 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)
  • Costs associated with a re-audit

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

  • 4.9.7 Investigator records
  • 5.1.2 Sponsor general
  • 5.19.3 Auditing procedure
  • 5.20 Noncompliance
Abbreviations
  • CAPA – Corrective and preventive Actions
  • CTU – Clinical Trials Unit
  • EMA – European Medicines Agency
  • FDA – Food and Drug Administration
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISF – Investigator Site File
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Ethics and Laws ↦ Inspections and Audits ↦ Audit Certificate
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 Certificate

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