What is it? Why is it important?
- 90 days for ClinO studies
- 15 days for ClinO-MD studies
- 90 days for HRO research projects
For international studies with foreign authorities, study end date corresponds to the date when the last participating study site has ended the study (i.e. the last participant has had his/her last study visit).
Even though the study has ended, liability coverage against claims from study participants due to injuries sustained from study participation must remain operational for up to 10 years after study end.
The notification of any sustained injuries must be submitted within three years of becoming aware of the event. Time-barred claims are further defined in the Swiss Code of Obligations.
What do I need to do?
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. swissmedic submission portal)
- Submitting the document(s) by post, both in paper and electronic form (CD)
File notification forms in the study TMF.
As a SP-INV and Site-INV, be aware that the liability coverage of your study does not end with the study, but remains valid for a minimum of an additional 10 years.
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
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: Working instructions Guideline Amendments Clinical Trials
- FO-template: BW101_10_019e_FO confirmation electronic submission
Declaration of Helsinki – see in particular principle
- 34 Post-Trial Provisions
SAMS Research with human subjects – see in particular chapter
- Chapter 9 Respect of participants / liability for damage
MDR 2017 – see in particular intro-points / articles
- Intro-point 31 Damage claims
- Intro-point 66 Civil or criminal liability
- Art. 10 General obligations of manufacturers
- Art. 69 Damage compensation
HRA – see in particular article
- Art. 19 Liability
ClinO – see in particular articles and annex
- Art. 10-14 Liability and Coverage
- Art. 38 Notification and reporting upon completion, discontinuation or interruption of a clinical trial
- Annex 2. Policy values for liability coverage
ClinO-MD – see in particular article
- Art. 3 Applicable provisions
- Art. 36 Reporting the conclusion, termination or interruption of a clinical trial
HRO – see in particular article
- Art. 13 Liability coverage
- Art. 22 Notification upon completion or discontinuation of a research project
- Art. 36 Notification requirements
- Art. 40 Notifications
Code of Obligation – see in particular article
- Art. 60 Claims and time limits
Swiss Code of Obligations:2021 – see in particular article
- Art. 60 Right to claim damages