What is it? Why is it important?

Based on given criteria, the HRA ordinances (ClinO. CinO-MD, HRO) assign studies to different risk categories. The aim of study categorisation is to ensure that study participants are protected from anticipated study risks.

Categories are:

  • Either category A, B, or C
  • Given different risk levels with category A studies having the lowest and category C having the highest risk.

Based on the risk category, different requirements apply, such as:

  • Documents required for EC/RA submission
  • Study relevant templates (e.g. study protocol, PIS / ICF)
  • Approval procedures

What do I need to do?

As a SP-INV, define the risk category of your study:

  • Consider the aim of your study and your study design (e.g. new drug, placebo controlled), including the type of data or biological material that needs to be collected
  • Check the HRA ordinances, which outline the conditions that must be met for each category (e.g. ClinO, HRO, ClinO-MD)
  • Use the KOFAM online tool, which helps you to determine the risk category of your study
  • If still in doubt, submit your questions to your responsible EC through BASEC They can provide useful advice

The risk category for your study will be review and approve by EC. If required, the EC will adapt the risk category of 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

  • BASEC: the portal for EC submission

References

KOFAM: Coordination portal for human research – see in particular – see in particular

  • Online wizard for risk categorisation

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.301 HRO
  • 810.305 ClinO
  • 810.306 ClinO-MD

ClinO – see in particular articles

  • Art. 19 Categorisation of medicinal products
  • Art. 20 Categorisation of in vitro diagnostic MD and products
  • Art. 21 Categorisation of transplant products
  • Art. 22 Categorisation of gene therapy and genetically modified or pathogenic organisms
  • Art. 49 Categorisation of transplantation of human organs, tissues and cells
  • Art. 61 Categorisation of other clinical studies

ClinO-MD – see in particular article

  • Art. 6 Categorisation of clinical trials

HRO – see in particular article

  • Art. 7 Categorisation
Abbreviations
  • BASEC – Business Administration System for Ethics Committees
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials for Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • KOFAM – Coordination portal for human research
  • MD – Medical Device
  • PIS – Patient Information Sheet
  • SP-INV – Sponsor Investigator
Concept ↦ Ethics and Laws ↦ Study Categorisation ↦ Procedures
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): Concept ↦ Ethics and Laws ↦ Study Categorisation ↦ Procedures

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