Dear Sir or Madam,

You are receiving this reminder from swissethics because your clinical trial /research project(s) with persons with the BASEC ID(s) : has/have an expected study end date in BASEC which is at least 6 months in the past, but you have not notified the (Lead-) Ethics Committee if the study/studies is/are completed or still ongoing.

Therefore:

  • If the clinical trial / research project is still ongoing, you must notify the study period extension as a substantial amendment to the (Lead-) Ethics Committee. Additionally, do not forget update the expected study end date in BASEC on screen 2 (Project details).
  • If the clinical trial / research project is completed or was discontinued or interrupted, you must notify the  (Lead-) Ethics Committee in BASEC, accordingly. To do so you need to fill in and upload the following form on screen 6 (Lead EC: General and main site’s documents) in the category 39 “Miscellaneous and Varia”.

While reminding you about your legal obligations to notify the end of study and significant changes to the Ethics Committees (see below the applicable articles), we thank you in advance for your attention on the above and for an immediate corrective action.

Sincerely yours,
swissethics

 

Applicable ordinances:

Regular end of study (clinical trial and research project):
The end of a study (clinical trial or research project) has to be submitted to the (Lead-) Ethics Committee that approved the clinical trial

or the research project within 90 days of its conclusion (ClinO Art 38; HRO Art 22, 36, 40, 43).

Study discontinuation or early termination:
The (Lead-) Ethics Committee must be notified within 15 days of a discontinuation or early termination of the clinical trial (ClinO Art 38, Abs. 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 research project (HRO Art 22).