Completion↦Ethics and Laws↦Inspections and Audits↦Procedures
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Inspections can occur even after the study has ended and all its documents have been archived.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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
Declaration of Helsinki – see in particular principle
- 34 Post-Trial Provisions