What is it? Why is it important?
The end of a study must be notified to EC and, if applicable, Swissmedic within:
- 90 days for HRO studies
- 90 days for ClinO studies
- 15 days for ClinO-MD studies
For international studies, study end date corresponds to the date when the last participating study site has ended the study.
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)
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 article
- Art. 38 Notification and reporting upon completion, discontinuation or interruption of a clinical trial
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 of a research project
- Art. 36 Notification requirements
- Art. 40 Notifications