Registration in the Swiss National Clinical Trials Portal (SNCTP)
The Federal Act on Research involving Human Beings (HRA) and the Ordinance on Clinical Trials in Human Research (ClinO) provide that research projects must be registered and published in a WHO primary register or on clinicaltrials.gov as well as in the supplementary federal database in the form authorised by the responsible ethics committees. These registrations have to be made before the clinical trial starts*.
The Swiss National Clinical Trials Portal (SNCTP) is the supplementary federal database for research projects carried out in Switzerland. The online-platform BASEC allows the automatic transfer of the information entered on Screen 4 “SNCTP” of the research application form, into the SNCTP. Changes to the “SNCTP” Screen are also automatically transferred to the SNCTP.
A project will be transferred if the following conditions are met:
- It has to be a clinical trial as defined by the Ordinance on Clinical Trials in Human Research (ClinO);
- The project must be approved by the competent Ethics Committee and by Swissmedic (for clinical trials of category B and C) and/or by the Federal Office of Public Health (FOPH, for clinical trials involving radiation sources, gene therapy, clinical trials of genetically modified or pathogenic organisms, and clinical trials of the transplantation of human organs, tissues and cells);
- The sponsor of the clinical trial must agree* to the automatic data transfer from BASEC into the SNCTP, by ticking the corresponding answer to the question on screen 4. SNCTP of the research application form. The information must be entered in one of the Swiss national languages (German, French or Italian).
- The Applicant has entered a registry name and registry number on the submission form. (Can be done as an update after first submission, if the number is not know at the time of first submission).
*The sponsor can postpone the registration of Phase I clinical trials up to one year after the completion of the clinical trial (ClinO art. 65).
If the sponsor doesn’t agree to the automatic transfer in the first submission to the ethics committee, the corresponding box on screen 4 “SNCTP” has to be updated after the approval is received and before the start of the clinical trial (phase 2 and 3 trials), or not later than 1 year after the completion of the clinical trial (phase I trials).
Registration and update of pre-BASEC projects
Clinical studies that were submitted to the EC between the entry into force of the HRA (1.1.2014) and the introduction of BASEC (1.1.2016) must be registered in SNCTP by using the following form. This form must be sent by email to: email@example.com. Please also use this form for any updates to the SNCTP-fields.