What is it? Why is it important?

A contract is a written, dated, and signed document between two or more involved parties. The contract defines what tasks have been delegated, its applicable responsibilities, including any financial aspects.

Partner agreements can be with

  • Service Providers:
    • Hospital internal services: such as pathology, radiology, laboratories, and pharmacy
    • Hospital external services: such as vendors providing selected study services, materials, and expertise (e.g. monitoring, statistician, data manager, insurance companies)
  • Multicentre studies: studies with more than one study site from same or separate language region(s)

More

Contract development can include many players:

  • The SP-INV of the study
  • Hospital legal department
  • Hospital management
  • Partner representative (e.g. additional study sites, laboratories, monitoring, data management, statistics)
  • Partner legal department

What do I need to do?

Prepare a contract which might include:

  • Type of service requested
  • Nature of collaboration
  • Respective tasks and responsibilities
  • Expected timeline of provided services including milestones
  • Financial agreement including a payment plan
  • Confidentiality
  • If applicable, publication rights
  • Legal dispute

A contract is reviewed and approved by the:

  • Hospital legal department and its management
  • Partner and its legal department

The main contract between SP-INV and grant provider or Site-INV in a multicentre study must be submitted to the EC.

For more information refer to Protocol in this Study Guide.

More

Based on a payment plan, pay-out can be implemented in a step-like arrangement such as after a given goal-set (e.g. upon EC/RA approval, inclusion of a set number of participants).

Plan adequate time for contract development, as there are many players involved and time required until contract approval can be lengthy. Consequently, evaluate and decide early on the need for outsourcing study services.

Where can I get help?

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

External Links

Swissethics – see in particular

  • 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
  • 5.9 financing

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

  • 6.9 Agreements
  • 9.3 Outsourcing
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA - Ethics Committee / Regulatory Authorities
  • CH-GCP – International Council for Harmonisation - Good Clinical Practice
  • INV – Investigator
  • ISO – International Organization for Standardization
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Management ↦ 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 ↦ Management ↦ Study Management ↦ Contract

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