Was betrifft es? Warum ist das wichtig?

The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) “other clinical studies” which do not include the use of:

 

These studies use or implement other types of medical, psychological, or physiological interventions or procedures (e.g. surgery, psychotherapy, physiotherapy, behavioural sciences, diet and nutrition).

 

For other clinical studies, risk-categories A or C apply, with A having a low and C a high risk.

Mehr

Risk-categorisation in “other clinical studies”:

Risk-Category A: if the study

  • Entails only minimal risks and burdens; or
  • Is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria

 

Risk-Category B if the study:

  • Entails more than minimal risks and burdens; and
  • Is not recognised as standard as specified under category A

 

In particular, minimal risks and burdens may be associated with:

  • Surveys and observations
  • Peripheral venous or capillary blood sampling and skin punch biopsies of limited extent
  • Non-invasive interventions removing or collecting bodily substances, in particular, saliva, urine and stool samples
  • Taking swabs
  • Magnetic resonance imaging scans without a contrast medium
  • Ultra-sound examinations or electrograms
  • Accompanying examinations involving ionising radiation, provided the effective dose is below 5 mSv per research project and person concerned, without using a contrast medium and:
    • The radiopharmaceutical is used in accordance with authorisation or are exempt from authorisation, or
    • Using an authorised MP in accordance with instructions for use

Was muss ich befolgen?

As a SP-INV planning “other clinical studies”, you are required to know and comply with the requirements defined in the ClinO ordinance:

  • Familiarise yourself with the organisation of the various chapters and sections
  • Focus on the articles that are relevant to your study

 

Prior to implementation, “Other clinical studies” require the approval of the Ethics Committee (EC). Submit your application dossier to EC who provides a reply, after acknowledgement of receipt of the formally correct application documents, within:

  • 30 days for monocentric studies
  • 45 days for multi-centre studies

 

"Other clinical studies” are exempt from submission and approval by regulatory authorities (e.g. Swissmedic, FOPH).

Wo kann ich Hilfe anfordern?

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

  • Templates and checklists
    • Study protocols / Other clinical trials

References

HumRes: Coordination portal for human research in Switzerland

Swiss Law

ClinO – see in particular articles and annex

  • Art. 2 Definition of minimal risks and burdens
  • Art. 61 Categorisation of other clinical studies
  • Art. 62 Procedures and deadlines EC
  • Annex 3 Application documents to EC
Abkürzungen
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • HumanRes – Human Research Switzerland
  • MD – Medical Device
  • MP – Medicinal Product
  • mSv – Millisievert
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Other Clinical Studies
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): Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Other Clinical Studies

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