What is it? Why is it important?

Study Registries are web-based platforms where detailed information about studies is published.

Like clinicaltrials.gov a registry has the aim to:

  • Provide patients, their families, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies.

Sharing scientific information is an important mean to further clinical research with the goal to provide improved treatment options to the general population.

What do I need to do?

During set-up phase and upon EC and RA approval the study was registered in:

  • An international public WHO registry, and
  • The federal database (SNCTP).

Upon study completion, discontinuation or interruption, applicable updates must be made in these registries.

Registries have clear requirements regarding type of information that must be published and made available to the public (e.g. included participants, study design and methods used, results including their interpretation).

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

  • https://clinicaltrials.gov
  • https://who.int
  • https://eudract.eme.europa.eu/
  • https://submisstion.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)

References

HRA – see in particular article

  • Art. 56 Registration
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethic Committee
Completion ↦ Management ↦ Publishing ↦ Study Registries
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): Completion ↦ Management ↦ Publishing ↦ Study Registries

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