Submission of end of study (clinical trial or research project) to the ethics committee
When and how to notify the end of a clinical trial / research project to the Ethics Committee
Index:
1. Definitions
2. When should the regular end of a study be reported and to whom?
3. When should the premature discontinuation or premature termination of a study be reported and to whom?
4. How to notify the end of a study to the Ethics Committee
5. Reminder for clinical trials
1. Definitions
When does a study (a clinical trial or a research project) end?
The completion of a study involving persons in Switzerland is defined as the date of the ‘last participant’s final follow-up visit in Switzerland’, unless otherwise specified in the protocol (ClinO Art. 38, ClinO-MD Art. 36).
The global completion of a multinational study is marked by the last participant’s final follow-up visit, in the absence of provisions to the contrary in the protocol (ClinO Art. 38, ClinO-MD Art. 36).
The completion of a research project with persons under HRO is marked by the last collection of health-related personal data or the last sampling of biological material, in the absence of provisions to the contrary in the protocol (HRO Art. 6a). The period of data collection should be defined in the research project protocol.
The completion of a research project under Chapters 3-5 HRO is is not explicitly defined in the ordinance. The project is therefore considered terminated when all activities related to the project have been completed (the publication of the research project results is excluded).
2. When should the regular end of a study be reported and to whom?
- Notification of regular completion of the clinical trial (ClinO):
The completion of a clinical trial must be submitted to the (Lead-) Ethics Committee that approved the clinical trial or the research project within 30 days of its conclusion in Switzerland (ClinO Art. 38).
The (Lead-) Ethics Committee is notified within 90 days of the global completion of a multinational clinical trial.
The “notification of trial completion” is submitted electronically through BASEC on screen 6 (Lead EC: General and main site’s documents). See chapter 4 below.
- Notification of regular completion of the clinical trial of medical device (ClinO-MD):
The completion of a clinical trial of medical devices has to be submitted to the (Lead-) Ethics Committee that approved the clinical trial within 15 days of its conclusion (ClinO-MD Art. 36).
The “notification of trial completion” is submitted electronically through BASEC on screen 6 (Lead EC: General and main site’s documents). See chapter 4 below.
- Notification of regular completion of the research project (HRO):
The completion of a research project must be submitted to the (Lead-) Ethics Committee that approved the clinical trial or the research project within 90 days of its conclusion in Switzerland (HRO Art. 22, 36, 40, 43 and 46)
The “notification of the project completion” is submitted electronically through BASEC on screen 6 (Lead EC: General and main site’s documents). See chapter 4 below.
3. When should the premature discontinuation or premature termination of a study be reported and to whom?
- Premature termination of the clinical trial (ClinO):
The (Lead-) Ethics Committee must be notified within 15 days of a premature termination of the clinical trial (ClinO Art 38, Abs. 2). In a multicenter clinical trial, the Lead Ethics Committee will inform the concerned ECs.
- Premature termination of the clinical trial of medical device (ClinO-MD):
The (Lead-) Ethics Committee must be notified within 15 days of a premature termination of the clinical trial of medical device (ClinO-MD Art 36, Abs. 3). In a multicenter clinical trial, the Lead Ethics Committee will inform the concerned ECs.
If the discontinuation is for safety reasons, the notification to the (Lead-) Ethics Committee must be made within 24 hours (ClinO-MD Art. 36, Abs. 4).
- Premature termination of the research project (HRO):
The (Lead-) Ethics Committee must be notified within 90 days of a premature termination of the research project (HRO Art. 22, 36, 40, 43 and 46). In a multicenter clinical trial, the Lead Ethics Committee will inform the concerned ECs.
4. How to notify the end of a study to the Ethics Committee
The notification of the end of a study must be done in BASEC exclusively.
1. The completed ‘end of study notification’ is done on screen ‘6. Lead EC: General and main site’s documents’ in the 'section for subsequent notifications and submissions / Notification of completion, discontinuation or interruption of the clinical investigation / performance study'. Fill in all the fields, as appropriate.
2. On the last screen ‘14. Submission Summary’ fill in / update the table 'Submission details and comments', tick the checkbox 'Termination (regular or premature)'.
3. The ‘Submit’ button is located at the bottom of the page.
If there is no feedback from (Lead-) Ethics Committee within 15 days, the ‘end of study notification’ has been silently acknowledged.
Note: The ‘silent acknowledgment’ does not apply to the discontinuation or interruption of the clinical trial or of the research project.
6. Reminder for clinical trials
Final clinical study report:
A final clinical study report should be submitted to the (Lead-) Ethics Committee within a year after completion or discontinuation of the clinical trial, unless a longer period is specified in the protocol (ClinO Art. 38, Abs 3; ClinO-MD Art. 37 Abs 1, 2).
In multinational clinical trials, the clinical study report should be submitted within a year after the global completion or discontinuation of the multinational clinical trial.
For a ClinO clinical trial the clinical study report is submitted via BASEC on screen 6 (Lead EC: general and main site’s documents) and category 41. Final report.
For a ClinO-MD clinical trial the report is submitted on screen 6 and category 37. Final report.
Note: In case of premature termination of a clinical trial of medical device, the clinical study report will be submitted to the (Lead-) Ethics Committee within 3 months (ClinO-MD Art. 37, Abs 1).
Note: It is not required to submit the clinical study report for research projects that fall within the scope of the Human Research Ordinance (HRO).