Notification of the first visit of the first participant

Article 38, paragraph 1a of the Ordinances on Clinical Trials in Human Research (ClinO) requires that the investigator shall notify the ethics committee, within 30 days, of the first visit of the first participant in the clinical trial in Switzerland.

The date of the enrolment of the first participant is defined as the date on which the first participant or the person that has been designated as the legal representative signs the first informed consent.

How do I notify the first visit of the first participant in Switzerland?

1. Go to screen 6 Lead EC, section for subsequent notifications and submissions, point 51, and fill in the 3 fields.
   
2. If applicable, go to screen 4. HumRes, and update the status of recruitment in Switzerland.
   
3. Go to screen 14 Submission Summary and tick the box 5.1 notification of the first visit of the first participant in Switzerland, and if applicable tick the box 4.3 changes to HumRes
   
4. Submit the form (the “submit” button is at the bottom of screen 14).