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

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  • 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.

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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

Your local and/or lead EC can give you advice on this topic

External Links

  • https://clinicaltrials.gov
  • https://www.who.int/ictrp/network/en/ https://eudract.ema.europa.eu/
  • https://submission.swissethics.ch/en/ (BASEC - Business Administration System for Ethics Committees)
  • www.kofam.ch
  • https://www.kofam.ch/en/snctp-portal/
  • Registry of all Projects in Switzerland (RAPS) - Registry database of all projects approved by the ethics committees in Switzerland

Swiss Law

ClinO – see in particular articles

  • Art. 64-66 Registration
Abbreviations
  • BASEC - Business Administration System for Ethics Committees
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Author
  • HRO – Human Research Ordinance
  • ID – Identity
  • KOFAM – Koordinationsstelle Forschung am Menschen
  • RAPS - Registry of all Projects in Switzerland
  • SNCTP - Swiss National Clinical Trials Portal
  • SP-INV – Sponsor-Investigator
Set-Up ↦ Management ↦ Registration ↦ Research Transparency
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Set-Up ↦ Management ↦ Registration ↦ Research Transparency

Please note: the Easy-GCS tool is currently under construction.