What is it? Why is it important?

Based on the HRA law, relevant study documents must initially be submitted and approved by health authorities prior to being implemented in a study.

 

Applicable health authorities include:

 

Extend of documents that must be submitted, including which health authority to submit to is based on the:

More

Ethics Committee: All studies and their respective documents must be submitted and approved by EC, irrespective of the respecitve ordinance applicable to the study, study type (mono- multicentre), study risk-category, and study set-up (e.g. study design, use of placebo, blinded study)

 

Swissmedic: The following studies and their respective documents must be submitted and approved by Swissmedic:

 

FOPH: In addition to Swissmedic the following studies must submit their documents to the FOPH:

  • ClinO studies with:
    • Gene therapy, genetically modified pathogenic organisms
    • Transplantation of human organs, tissues and cells, and with risk-category B and C
    • Studies with radiation sources exceeding 5mSv/year for participants, and with risk-category C
  • HRO studies with radiation sources exceeding 5mSv/year for participants

What do I need to do?

As a SP-INV and based on your study, make yourself familiar with which documents must be submitted to Ethics Committee (EC), RA (e.g. Swissmedic), and FOPH respectively.

 

Ethics Committee submission:

  • Study documents are uploaded on BASEC, the EC electronic submission portal
  • Create a personalized BASEC login
  • Upload all EC required documents (e.g. also listed in the ClinO, ClinO-MD, HRO ordinances)

 

Swissmedic submission:

  • Pepare a CTA dossier
  • Include documents according to given guidelines

 

FOPH additional submission:

  • Upload all FOPH required documents as listed in the ClinO and HRO ordinances

More

When submitting to health authorities, submission to EC, Swissmedic and FOPH, can be done concurrently, as applicable.

Based on the law, each study is risk-categorized (e.g. risk category A, B, C).

Upon submission remember to register your study (e.g. ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP), on the federal Human Research (HumRes) website).

Study registration is not done on the "Human Research" website, but will be automatically uploaded on the "Human Research" website once the study has been registered in BASEC (i.e. the Business Administration System of the Swiss Ethics Committee).

Where can I get help?

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

External Links

Swissethics – see in particular

  • BASEC (the EC submission portal) list of required documents for EC submission
  • RAPS: EC approved projects in Switzerland

Swissmedic – see in particular

  • Guidelines for CTA dossiers submitted

BAG – see in particular

  • Transplantationsgesetz, SR 810.21
  • Transplantationsverordnung, SR 810.211
  • Xenotransplantationsverordnung, SR 810.213
  • Strahlenschutzgesetz
  • Strahlenschutzverordnung

Study Registration

Swiss Law

ClinO – see in particular article and annexes

  • Art. 23 Coordination and information in authorisation procedures
  • Annex 3 Application documents to EC
  • Annex 4 Application documents to Swissmedic and FOPH
  • Annex 3, Chapter 6 FOPH application for studies involving radiation sources

ClinO-MD – see in particular annex

  • Annex 1 Application documents for study approval

HRO – see in particular articles and annex

  • Art. 23 Assessment, notification and reporting on the use of radiation sources
  • Annex 2 Based on study application documents to be submitted to the responsible EC and FOPH
Abbreviations
  • BAG – Bundesamt für Gesundheit
  • BASEC - Business Administration System for Ethics Committees
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Device
  • CTU – Clinical Trials Unit
  • CTA – Clinical Trial Application
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • HumRes – Human Research in Switzerland
  • OrgO-HRA - Ordinance on Organisational Aspects of the Human Research Act
  • RA - Regulatory Authorities
Development ↦ Documents ↦ Required Documents ↦ Document Submission
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): Development ↦ Documents ↦ Required Documents ↦ Document Submission

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