Your Easy Guide to Clinical Studies

In order to guarantee research transparency all studies should be registered. The following registration guidelines apply.

 

Studies (e.g. ClinO, ClinO-Others, ClinO-MD), irrespective of risk-category must be registered in:

• An international public registry, namely in:
  • A primary registry recognised by the World Health Organization (WHO), or
  • The registry of the U.S. National Library of Medicine - clincialtrials.gov
• A federal database (supplementary database), such as the SNCTP (Swiss National Clinical Trials Portal) to be found on the KOFAM website. Note: all information must be entered in a Swiss national language

 

The SP-INV is responsible for the accuracy and completeness of all data entered in the registry.

 

Registration of HRO projects is not required. Still, project registration promotes research transparency, and increases the chance for journal publication. Research projects can be registered in the “Registry of all projects in Switzerland” (RAPS) by swissethics.

As a SP-INV, familiarize yourself with how to register your study. Procedures include to:

• Register the study upon EC/RA (e.g. Swissmedic) approval but prior to study conduct. An exception are first in human studies that must be registered no later than 1 year after completion.
• Enter study information in an international public registry 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)
• Enter and update study information in accordance with requirements of the registry in question, but at least once a year

 

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”

External Links

Swissethics – see in particular

• BASEC: EC submission portal

• RAPS: EC approved projects in Switzerland
• SNCTP: FOPH Swiss national clinical trial portal

Declaration of Helsinki – see in particular principle

• 36 Publication of research results

SAMS Research with human subjects – see in particular chapter

• Chapter 11 Publication of study results

Swiss and international registries:

• KOFAM (SNCTP) - Swiss National Clinical Trials Portal
• ClinicalTrials.gov
• WHO – ICTRP Registry Network
• EudraCT – Clinical Trials Database

Swiss Law

HRA - see in particular article

• Art. 56 Registration

ClinO – see in particular articles and annex

• Art. 64 Approved registers and data to be entered
• Annex 5
  • 1. Data to be entered in a register
  • 2. Data to be entered in the supplementary database
• Art. 65 Time of registration
• Art. 66 Responsibility
• Art. 67 Portal: public access to clinical trials in Switzerland

ClinO-MD - see in particular article

• Art. 41 Registration
• Art. 42 Publication of results