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An inspection or audit can be requested even though the study has ended, and all its documents have been archived.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?
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