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Submission of end of study (clinical trial or research project) to the ethics committee

Solution

When and how to notify the end of a clinical trial / research project to the Ethics Committee

 

Definitions:

When does a study (a clinical trial or a research project) end?

The end of a study involving persons is defined as the date of the ‘last participant’s final follow-up visit in Switzerland’, unless otherwise specified in the protocol.

The end of a study using only health-related personal data and/or biological material ("further use") is ‘the completion of the collection process’ (HRO Art 40 and by analogy Art 36). The period of data collection should be defined in the research project protocol.
(This also goes for research involving deceased persons and research involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths. HRO Art 43 and 46, respectively)

When should the regular end of a study be reported and to whom?

The end of a study has to be reported to the (Lead-) Ethics Committee that approved the study within 90 days of its conclusion (ClinO Art 38; HRO Art 22, 36, 40, 43 and 46).

When should the early discontinuation or early termination of a study be reported and to whom?

The (Lead-) Ethics Committee must be notified within 15 days of a discontinuation or an early termination of a clinical trial (ClinO Art 38 (2)). In a multicenter clinical trial, the Lead Ethics Committee will inform the concerned ECs.

The (Lead-) Ethics Committee must be notified within 90 days of the discontinuation or the early termination of a research project (HRO Art 22, 36, 40, 43 and 46).

Are there formal requirements for the end of trial notification?

It is recommended by the Ethics committees to fill out the «template for the notification of the end of a clinical trial or of a research project to the Ethics Committee and in case of discontinuation or interruption» (abbreviated to ‘end of study notification‘), which is available on swissethics.ch.

Direct link to the template ‘end of study notification’ here: .docx

Please ensure that the ‘end of study notification’ is filled out completely and signed before it is uploaded to BASEC. The (Lead-) Ethics Committee can request a new report if the submitted report contains errors, gaps or if it is not signed. If a different template is used, please ensure that all relevant information is submitted to the Ethics Committee in the document itself or in a cover letter.

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’ must be uploaded on screen ‘6. Lead EC: General and main site’s documents’ in category ‘39. Miscellaneous / Varia’.

2.     On the last screen ‘14. Submission Summary’ fill in / update the table 'Submission details and comments / Termination (regular or premature)' (1) and indicate the reason for the study termination. The ‘Submit’ button is located at the bottom of the page (2).

 

 

The end of a clinical trial or of a research project is acknowledged by the (Lead-) Ethics Committees. If there is no feedback within 15 days, the ‘end of study notification’ has been silently acknowledged by the (Lead-) Ethics Committee.

Note: The ‘silent acknowledgment’ does not apply to the discontinuation or interruption of the clinical trial or of the research project.

 

Reminder for clinical trials:

Final clinical study report:

A final clinical study report must be submitted within a year after completion or discontinuation of the clinical trial, unless a longer period is specified in the protocol (ClinO Art 38 (3)).

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.

The clinical study report is submitted via BASEC on screen ‘6. Lead EC: General and main site’s documents’ in category ‘41. Final report’. The clinical study report will be acknowledged by the (Lead-) Ethics Committee. This acknowledgement can be silent.

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).

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