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, such as the Swiss Clinical Trials Portal of Human Research in Switzerland (HumRes). Please note:
  • All information must be entered in a Swiss national language
  • Study registration is not done on the "HumRes" website. The study will be automatically uploaded on the "Human Research" website once the study has been entered and registered in BASEC (i.e. the Business Administration System of the Swiss Ethics Committee).

As a SP-INV, you are responsible for the accuracy and completeness of all data entered in the registry

 

Procedures include to:

• Register the study upon EC/RA (e.g. Swissmedic) approval but prior to study conduct. 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 (i.e. the swissethics submission portal). 
• Enter and update study information in accordance with registry requirements, but at least once a year

 

Registration of HRO projects is not required. Still, project registration promotes research transparency. HRO projects can be registered in the RAPS registry (i.e. the registry database of all projects approved by the Ethics Committees in Switzerland)

External Links

Swissethics – see in particular

• BASEC: EC submission portal
• RAPS: EC approved projects in Switzerland

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:

• HumRes – Coordination portal of human resarch in Switzerland
• 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