Was betrifft es? Warum ist das wichtig?

The "Human Research Switzerland (HumRes)" portal is the Federal Office of Public Health’s (FOPH) website for the public on human research in Switzerland.

The website provides information by focusing in three main aspects:

  1. More information on human research. addresses the public and persons who want to know what research is, and how to potentially participate in a clinical study or research project
  2. Study search: is a search tool where users can search for studies, and find out whether a study is still recruiting participants and who to contact.
  3. Frequently asked questions: answers are provided to the public and researchers, especially regarding information on study submission requirements

Was muss ich befolgen?

As a SP-INV or project-leader you are required to register your study on the "Human Research" website, and make appropriate updates during study conduct, and document the completion or interruption of your study.

Study registration is not done on the "Human Research" 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).

Wo kann ich Hilfe anfordern?

Your local Research Support Centre can assist you with experienced staff regarding this topic

  • Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch

  • Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch

  • Bern, Department of Clinical Research (DCR), dcr.unibe.ch

  • Geneva, Clinical Research Center (CRC), crc.hug.ch

  • Lausanne, Clinical Research Center (CRC), chuv.ch

  • St. Gallen, Clinical Trials Unit (CTU), h-och.ch

  • Zürich, Clinical Trials Center (CTC), usz.ch

Experienced staff at your local CTU can provide you with support on this topic

External Links

Swissethics  – see in particular  

BASEC – The Business Administration System for the Ethics Committees

References

HumRes – Coordination portal for human research in Switzerland

Swiss Law

HRA – see in particular article

  • Art. 56 Registration

ClinO – see in particular chapter

  • Chapter 5 Registration
Abkürzungen
  • BASEC – Business Administration System for Ethics Committees
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • HRA – Human Research Act
  • HumRes – Human Research Switzerland
  • SP-INV – Site Investigator
Basic ↦ Ethics and Laws ↦ Human Research Coordination Portal ↦ Human Research in Switzerland
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Drug or Device
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Human Research Coordination Portal ↦ Human Research in Switzerland

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