What is it? Why is it important?
In order to guarantee research transparency all studies should be registered. The following registration guidelines apply
ClinO studies, irrespective of category must be registered in:
- An international public registry, namely
- In a primary registry recognised by the World Health Organization (WHO); or in the registry of the U.S. National Library of Medicine - clincialtrials.gov
- Federal database:
- SNCTP: Swiss National Clinical Trials Portal to be found on the KOFAM website
- All information must be entered in a Swiss national language
- Entered data is updated in accordance with requirements of registry in question, but at least once a year
- The SP-INV is responsible for the accuracy and completeness of all data entered in the registry.
- Registration of HRO projects is not required, but can be done to promote transparency, and thus increase the chance for journal publications
- Research projects can be registered in the “Registry of all projects in Switzerland” (RAPS) by swissethics
What do I need to do?
When and how do I register my ClinO study?
- Upon EC/RA approval or prior to study conduct
- Enter study information in an International public register and transfer the allotted ID back into BASEC (swissethics submission portal).
- By activating the data transfer button in BASEC your study information is automatically transferred to the federal database (SNCTP)
Registration of a First in Human study must be no later than 1 year after completion.
In order to allow for the automatic data transfer from BASEC to SNCTP, activate in BASEC the button with the following text:
“I agree to the automatic transfer of the relevant data into SNCTP”.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
Your local and/or lead EC can give you advice on this topic
- https://www.who.int/ictrp/network/en/ https://eudract.ema.europa.eu/
- https://submission.swissethics.ch/en/ (BASEC - Business Administration System for Ethics Committees)
- Registry of all Projects in Switzerland (RAPS) - Registry database of all projects approved by the ethics committees in Switzerland
ClinO – see in particular articles
- Art. 64-66 Registration