What is it? Why is it important?

Study insurance provides financial protection for the SP-INV including compensation for participants should they suffer harm as a result.

Insurance:

  • Is required for all studies
  • Is either covered through the insurance of the hospital or an additional third-party insurance is required
  • Must cover any claims arising from a period for up to 10 years after study completion.

The SP-INV is responsible to provide applicable study insurance.

More

If required, the SP-INV is responsible to provide financial compensations to study participants, including Site-INVs or its institution against claims arising from the study.

Exceptions are claims that arise from Site-INV malpractice and/or negligence.

What do I need to do?

Based on your study, make yourself familiar with insurance requirements at your institution.

Address issues such as:

  • Does your hospital provide insurance that covers clinical studies? If not provided by the hospital, you need to acquire additional third-party insurance
  • Include in your EC/RA submission package a certificate of insurance which covers patients claims including patient injuries and damage to properties for the entire trial
  • When submitting your study to the EC/RA include proof of insurance (e.g. third-party insurance certificate)

For more information refer to Ethics and Laws in this Study Guide.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Insurance template

References

ICH GCP E6(R2) – see in particular guidelines

  • 5.8.1 Insurance
  • 8.2.5 Essential documents

ISO 14155:2020 Medical devices - see in particular section (access liable to cost)

  • 5.6.2. Ethics submission (access liable to costs)

Declaration of Helsinki – see in particular principle

  • 15 Subject compensation

Swiss Law

HRA – see in particular article

  • Art. 19 and 20 Coverage

ClinO – see in particular articles

  • Art. 13 Requirement for liability coverage
  • Art. 14 Protection of the injured party
  • Annex 3 - 1.14/2.15/3.13/4.7 Ethics application

HRO – see in particular article

  • Annex 2 - 1.6/8.8 Ethics application
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • EC/RA - Ethics Committee / Regulatory Authorities
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ISO – International Organization for Standardization
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Management ↦ Insurance
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): Development ↦ Management ↦ Study Management ↦ Insurance

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