What is it? Why is it important?
The discontinuation or interruption of a study must be notified to EC, and if applicable Swissmedic within:
- 90 days, for HRO studies
- 15 days, for ClinO and ClinO-MD studies
- 24 hours, for ClinO-MD studies where study termination was due to safety reasons
What do I need to do?
As SP-INV notify:
- EC by:
- Submitting a notification form of study discontinuation or interruption via BASEC
- Swissmedic by:
- Completing a “FO submission form” available on the Swissmedic website
- Submitting the document(s) by post, both in paper and electronic form (CD)
With study / research project discontinuation or interruption, provide details and rational as to why the study was stopped.
File notification forms in the TMF.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
Swissethics – see in particular
- Templates and Checklists / Notifications / Template: Notification of the completion or discontinuation of the clinical trial or research project
Swissmedic – see in particular
- BW101_10_003e procedures to follow once the study is finished, or has been interrupted prematurely
- FO-template: BW101_10_019e_FO confirmation electronic submission
FEDLEX – laws are available online under numbers
- 810.305 ClinO
- 810.306 ClinO-MD
- 810.301 HRO
ClinO – see in particular articles
- Art. 38 Notification and reporting upon completion, discontinuation or interruption of a clinical trial
- Art. 57 Transplant studies -notifications and reporting
- Art. 62 Other studies - applicable provisions
ClinO-MD – see in particular article
- Art. 36 Reporting the conclusion, termination or interruption of a clinical trial
HRO – see in particular article
- Art. 22 Notification upon completion or discontinuation