What is it? Why is it important?

Study insurance:

  • Is required for studies
  • Guarantees participant compensation, should they suffer harm as a result of the study
  • Is either covered through a hospital/institution or an additional third-party insurer
  • Must cover claims arising from a period for up to 10 years after study completion

A contract:

  • Is an agreement between two or more involved parties (e.g. SP-INV and Site-INV or other relevant partners)
  • Defines and assigns delegated study tasks and responsibilities, including relevant financial aspects
  • Is dated and signed by all involved parties

More

The SP-INV must:

  • Guarantee adequate finances from study planning until its completion
  • Document financial aspects in a contract and in agreement with involved parties (e.g. external and internal partners, collaborating Site-INV(s) and their institution(s)
  • Provide each contract partner with an original fully signed contract
  • Provide insurance against claims arising from the study. An exception would be claims arising from malpractice or negligence

What do I need to do?

As a SP-INV:

  • Find out the insurance requirements of your study
  • Acquire a third-party insurer, if the hospital does not provide adequate insurance
  • Set-up contract(s) detailing any collaborating and financial aspects
  • Ask your legal department to review and approve the contract(s)
  • As applicable, forward contract(s) to the Site-INV(s) and applicable partner(s) for approval
  • File the fully signed contract and insurance certificate in the TMF

As a Site-INV:

  • File the insurance certificate of the study in the ISF
  • Review the contract provided by SP-INV
  • Forward the contract to your hospital legal department for review and approval
  • Return the fully signed contract(s) to the SP-INV and file a copy in the ISF

More

Based on the number of determined contract hard copies, ensure prior to filing that:

  • All relevant persons have dated and signed all available hard copies (e.g. the SP-INV, hospital/institution CEO, department director, Site-INV, other relevant partners).
  • The legal department retains a signed hard copy of the contract

When submitting your study to EC and if applicable RA for approval, ensure to include a signed contract including the study’s insurance certificate.

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
  • Clinical study agreement template

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.17 Contract definition
  • 4.5.1 Site contract
  • 4.9.6 Financial Agreement
  • 5.8.1 Insurance
  • 5.9 Financing
  • 8.2.5 ED – Insurance Statement

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

  • 5.6.2 Ethics submission
  • 6.9 Agreements
  • 9.3 Outsourcing

Declaration of Helsinki – see in particular principle

  • 15 Subject compensation

Swiss Law

HRA – see in particular articles

  • Art. 19 Liability
  • Art. 20 Coverage

ClinO – see in particular articles and annex

  • 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 annex

  • Annex 2 - 1.6/8.8 Ethics application
Abbreviations
  • CEO – Chief Executive Officer
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • ISF – Investigator Site File
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
Development ↦ Documents ↦ Required Documents ↦ Insurance and Contract
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 ↦ Documents ↦ Required Documents ↦ Insurance and Contract

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