What is it? Why is it important?

Based on given criteria, the HRA ordinances (ClinO, ClinO-MD, HRO) assign studies to different risk-categories. The aim of study risk 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 presenting the lowest and category C presenting the highest risk.


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

  • Documents required for Ethics Committee (EC) / Regulatory Authority (e.g. Swissmedic) submission
  • Study relevant templates (e.g. study protocol, PIS / ICF)
  • Approval procedures (e.g. risk-category B and C studies must in addition to EC also seek Swissmedic approval)
  • Study insurance (e.g. higher risk studies require more extensive coverage)
  • Safety reporting (e.g. is more extensive for high risk studies)
  • Extent of study monitoring (e.g. is more extensive for high risk studies)

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 (i.e.. ClinO, ClinO-MD, HRO)
  • 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 reviewed and approved 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


KOFAM: Coordination portal for human research – see in particular 

  • Online wizard for risk categorisation

Swiss Law

ClinO – see in particular articles

  • Art. 19 Categorisation of clinical trials of medicinal products
  • Art. 20 Categorisation of clinical trials of products under Article 2a paragraph 2 TPA
  • Art. 21 Categorisation of clinical trials of transplant products
  • Art. 22 Categorisation of clinical trials of gene therapy and genetically modified or pathogenic organisms
  • Art. 49 Categorisation of clinical trials 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 investigations

HRO – see in particular article

  • Art. 7 Categorisation

IvDO – see in particular

  • Art. 14 Classification
  • 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
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • IvDO – Ordinance on In Vitro Diagnostic Medical Devices
  • KOFAM – Coordination portal for human research
  • MD – Medical Device
  • PIS – Patient Information Sheet
  • SP-INV – Sponsor Investigator
  • TPA – Therapeutic Products Act
Concept ↦ Ethics and Laws ↦ Study Categorisation ↦ Procedures

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
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 Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Concept ↦ Ethics and Laws ↦ Study Categorisation ↦ Procedures

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