Your Easy Guide to Clinical Studies

The end of a study must be notified to the Ethics Committee (EC) and if applicable Swissmedic (e.g. ClinO risk-category B and C studies; ClinO-MD risk-category C studies).

 

Timelines are

• 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.

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.

 

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: Working instructions Guideline Amendments Clinical Trials
• FO-template: BW101_10_019e_FO confirmation electronic submission

References

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

Swiss Law

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