Your Easy Guide to Clinical Studies

The termination/discontinuation or interruption of a study must be notified to the Ethics Committee (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

As SP-INV notify:

• EC by:
  • Submitting a notification form of study discontinuation or interruption via BASEC (e.g. the EC submission portal)
• Swissmedic by:
  • Completing a “FO submission form” available on the Swissmedic website (e.g. the Swissmedic submission portal)
  • 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.

External Links

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

Swiss Law

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