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:

  • Ethics Committee (EC)
  • Swissmedic
  • Federal Office of Public Health (FOPH)

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

  • Respective ordinance that applies to the study (e.g. ClinO, ClinO-MD, HRO)
  • Study type (e.g. interventional versus observational studies, transplantation products, investigations involving ionising radiation)
  • Study risk-category (e.g. A,B,C, with A having a low risk and C a high risk)
  • Study set-up (e.g. multi- versus mono-centre studies)

More

EC*: All studies and their respective documents must be submitted and approved by EC, irrespective of ordinance, study type, study risk, and study set-up

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

  • ClinO studies with risk-category B and C
  • ClinO-MD studies with risk-category C
  • Therapeutic and transplant products with risk-category B and C
  • Studies with gene therapy, genetically modified pathogenic organism, and ionising radiation, with risk-category B and C

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?

Based on your study, make yourself familiar with which documents must be submitted to EC, RA (Swissmedic), and FOPH respectively.

EC 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

For more information refer to Ethics & Law in this Study Guide.

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). Access KOFAM that provides assistance in the risk categorisation of human studies.

Upon submission remember to register your study.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Instruction for EC submission

Swissmedic – see in particular

  • Guidelines for CTA dossiers submitted

References

BASEC – see in particular

  • List of required documents for submission

KOFAM is the SNCTP portal for human research for study registration and risk categorisation

BAG – see in particular

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

ClinicalTrials.gov – see in particular

  • Submit Studies

Swiss Law

OrgO-HRA – see in particular article

  • Ch. 1 Research and EC
  • Ch. 2 Coordination Office

HRA – see in particular article

  • Art. 2 Scope of the 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
  • KOFAM – Koordinationsstelle Forschung am Menschen
  • OrgO-HRA - Ordinance on Organisational Aspects of the Human Research Act
  • RA - Regulatory Authorities
  • SNCTP – Swiss National Clinical Trials Portal
Development ↦ Documents ↦ Required Documents ↦ Document Submission
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): Development ↦ Documents ↦ Required Documents ↦ Document Submission

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