What is it? Why is it important?

Liability coverage is an insurance that provides the insured party (the study SP-INV and hospital) with financial protection against claims (from study participants) resulting from injuries and damages sustained from study participation.

Liability coverage must cover claims, which are submitted for up to 10 years after the end of the study, including:

  • HRO research projects: research involving measures for sampling of biological material or the collection of health-related personal data from persons
  • ClinO clinical studies: studies of medicinal products, in vitro diagnostic medical devices or combinations / transplantation of human organs, tissues and cells / other clinical studies
  • ClinO-MD clinical studies: studies with medical devices

Notification of a damaging event must be within three years after becoming aware of the event. Time-barred claims are further defined in the Swiss Code of Obligations.

What do I need to do?

As a SP-INV and Site-INV, be aware that the liability coverage of your study does not end with the study, but remains valid for a minimum of an additional 10 years.

Thus, in the event of study-related damage claims during this extended period, proceed as required.

Where can I get help?

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

References

Declaration of Helsinki – see in particular principle

  • 34 Post-Trial Provisions

SAMS Research with human subjects – see in particular chapter

  • Chapter 9 Respect of participants / liability for damage

MDR 2017 – see in particular intro-points / articles

  • Intro-point 31 Damage claims
  • Intro-point 66 Civil or criminal liability
  • Art. 10 General obligations of manufacturers
  • Art. 69 Damage compensation

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.308 HRA
  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 220 Code of Obligations
  • 810.301 HRO

HRA – see in particular article

  • Art. 19 Liability

ClinO – see in particular article and annex

  • Art. 10-14 Liability and Coverage
  • Annex 2 Policy values for liability coverage

ClinO-MD – see in particular article

  • Art. 3 Applicable provisions

Code of Obligation – see in particular article

  • Art. 60 Claims and time limits

HRO – see in particular article

  • Art. 13 Liability coverage

Swiss Code of Obligations:2021 – see in particular article

Art. 60 Right to claim damages

Abbreviations
  • CTU – Clinical Trials Unit
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • MDR – Medical Device Regulation
  • SAMS – Swiss Academy of Medical Sciences
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Completion ↦ Ethics and Laws ↦ End of Study Notification ↦ Liability Coverage
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): Completion ↦ Ethics and Laws ↦ End of Study Notification ↦ Liability Coverage

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