What is it? Why is it important?

The aim of a Scientific Publication (SP) is to:

  • Make scientific discoveries and progress available to the research community
  • Make study results available to the general public
  • Provide data for further research


Researchers have an ethical obligation to make their study results public, whether they are positive, negative or inconclusive. Unpublished research is unethical and a waste of invested resources, scientific experience, and study participants who were exposed to potential risks.


Study outcome should be:

  • Published in a national- or international study registry (as a minimum in a registry recognized by the World Health Organization (WHO), such as the ClinicalTrials.gov). Valuable “lessons learned” should also be communicated
  • Reported in a clear, comprehensive, unbiased and honest manner

What do I need to do?

As a SP-INV:

  • Update the study on any selected internationally recognised public registries


For a scientific publication:

  • Decide authorship and author positions early on. Ensure authors have no potential conflict of interest
  • Try to publish your research results in a scientific peer-reviewed journal that targets applicable research communities. Grant data access to all those who may benefit from your study results
  • Include experts able to support you with the publication write-up (e.g. statistician, medical reviewer)
  • Adhere to publication agreements defined at study start (e.g. selection of publication partner(s), contribution and authorship, adherence to publication guidelines such as the ICMJE)
  • Consider informing study participants and/or their communities about your study results


Preferably publish in journals where research results are:

  • Available online providing open access licenses aimed at promoting reuse
  • Free of cost with less copyright restrictions

Avoid “predator”-journals – which are of poor quality

Where can I get help?

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

External Links

Swissethics – see in particular

  • RAPS Registry, a database of all projects approved by the ethics committees in Switzerland


Swiss and international registries:

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



Declaration of Helsinki – see in particular principle

  • 36 Registration and Publication and Dissemination of results

SAMS Research with human subjects – see in particular chapter

  • Chapter 11 Publication of study results

ICMJE – See in particular

  • Clinical trials recommendation


Swiss Law

HRA – see in particular article

  • Art. 56 Registration

ClinO – see in particular articles

  • Art. 64 - 67 Registration

ClinO-MD – see in particular

Art. 41 Registration

  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EudraCT – European Union Drug Regulating Authorities Clinical Trials Database
  • CTU – Clinical Trials Unit
  • HRA – Human Research Act
  • ICMJE – International Committee of Medical Journal Editors
  • KOFAM – Coordination Portal for Human Research
  • RAPS – Registry of all Projects in Switzerland
  • SAMS – Swiss Academy of Medical Sciences
  • SP-INV – Sponsor Investigator
  • RA – Regulatory Authorities
  • WHO – World Health Organization
Completion ↦ Management ↦ Publishing ↦ Scientific Publications

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Completion ↦ Management ↦ Publishing ↦ Scientific Publications

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