What is it? Why is it important?

Based on the planned study, different laws, regulations, directives and guidelines apply.

For interventional studies with an Interventional Medicinal Product (IMP) including other types of studies (e.g. transplantation, surgery, psychology, physiotherapy), the following laws and guidelines apply:

  • Declaration of Helsinki
  • ICH GCP E6(R2)
  • FADP
  • HRA
  • ClinO
  • TPA

For medical device studies, the following laws and guidelines apply:

  • Declaration of Helsinki
  • ISO 14155
  • FADP
  • HRA
  • ClinO-MD (with references to ClinO)
  • MedDO

For research projects involving the sampling of biological material or collection of health-related personal data (including further use), the following laws and guidelines apply:

  • Declaration of Helsinki
  • ICH GCP E6(R2) recommended as applicable
  • FADP
  • HRA
  • HRO

Also consider the following not legally binding documents:

  • Declaration of Taipei
  • ISO 20387 Biobanking

What do I need to do?

Know what applicable laws, regulations, directives and guidelines apply to your study.

Where can I get help?

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

References

ICH GCP E6(R2)

World Medical Association – see in particular current declarations

  • Declaration of Helsinki 2013 Ethical principles for medical research involving human subjects
  • Declaration of Taipei 2016 on ethical considerations regarding databases and biobanks

ISO (access liable to costs) – see in particular sections

  • 14155:2020 Medical device
  • 20387:2018 Biobanking

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 235.1 FADP
  • 810.30 HRA
  • 810.301 HRO
  • 812.213 MedDO
  • 812.21 TPA
Abbreviations
  • CTU – Clinical Trials Unit
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • FADP – Federal Act on Data Protection
  • FEDLEX – Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMP – Investigational Medicinal Product
  • ISO – International Organization for Standardization
  • MedDO – Medical Devices Ordinance
  • TPA – Therapeutic Products Act
Concept ↦ Ethics and Laws ↦ Study Planning ↦ Laws and Guidelines
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 Planning ↦ Laws and Guidelines

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