What is it? Why is it important?

The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) studies with Medicinal Products (MP). A MP tested in a study, is named an Investigational MP (IMP).

The study set-up and intervention type will decide the risk-category of the study (e.g. risk categories A, B, or C apply, with A having the lowest and C the highest risk).

 

IMP studies are categorised as follows:

Category A: The IMP

  • Is authorised in Switzerland and used:
    • In accordance with the prescribing information (PI)
    • In indication or dosage different from PI but a) within the same ICD disease group b) the disease is self-limiting and the IMP dosage is lower than in PI • Is recognised as standard guidelines prepared in accordance with international quality criteria
  • Is recognised as standard guidelines prepared in accordance with international quality criteria

 

Category B: the IMP is:

  • Authorised in Switzerland; and
  • Not used as specified in category A

 

Category C: the IMP is:

  • Not authorised in Switzerland.

More

In justified cases (if possible or necessary), and under consideration of the participants’ safety and health, a risk-category C study may be assigned to a different risk category.

 

IMP studies are categorised as follows:

  • With marketing authorisation used or assembled in a way different from the approved form (e.g. formulated, packaged)
  • Used for an unapproved indication (e.g. for the treatment of alternative diseases, a change in administration mode)
  • Used to gain further information about an approved use

What do I need to do?

As a SP-INV planning an IMP study, you are required to know and comply with the requirements defined in the ClinO ordinance.

 

Based on the risk-category of your study, submit your application dossier to:

  • The Ethics Committee (EC, application dossier) who grants authorisation of risk-category A, B, and C studies, and provides a reply within:
    • 30 days for monocentric studies
    • 45 days for multi-centre studies
  • Swissmedic (e.g. application dossier) who grants authorisation of risk-category B and C studies, and provides a reply within:
    • 30 days after acknowledgement of receipt of the complete application dossier
    • A potential additional 30 days for first in human studies, or for IMPs manufactured in a new process
    • Risk-category A studies are exempt from Swissmedic authorisation

 

A Swissmedic submission and an EC submission must be made in parallel.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Templates and checklists
    • Study protocols / Clinical trials

References

ICH GCP E6(R2) – see in particular article

  • Art. 1.33 Investigational product definition

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 IMP studies
  • Art. 26 Procedures and deadlines EC
  • Art. 27 Procedures and deadlines EC in multi-centre clinical trials
  • Art. 33 Procedures and deadlines Swissmedic
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRA – Human Research Act
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ICD – International Classification of Diseases
  • KOFAM – Coordination portal for human research
  • Classification of Diseases
  • IMP – Investigational Medicinal Product
  • MP – Medicinal Product
  • PI – Prescribed Information
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Medicinal Product Studies
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
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
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 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 Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
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