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 contracts are establised with:

  • Outsourced 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. laboratories, monitoring, statistician, data manager, insurance companies)
  • Study sites in multicentre studies: studies with more than one study site from the same or separate language region(s)


Contract development can include many players:

  • The SP-INV of the study
  • Hospital legal department
  • Hospital management
  • Partner representatives
  • Partner legal department

What do I need to do?

As a SP-INV, 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. Pay-out can be planned in a step-like manner, such as after reaching a given study milestone (e.g. upon Ethics Committe (EC) approval, inclusion of a set number of participants).
  • A confidentiality agreeement
  • If applicable, publication rights
  • The handling of legal dispute


A contract is reviewed and approved by the:

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

Plan adequate time for contract development, as there are many players involved. Time required until contract approval from all involved partners is therefore often lengthy.


Contracts between SP-INV and grant providers or Site-INV(s) in a multi-centre study are submitted to the EC for review and approval.

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


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 (access liable to cost) - see in particular sections

  • 6.9 Agreements
  • 9.3 Outsourcing
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC - Ethics Committee
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • Site-INV – Site Ivestigator
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Management ↦ Contract

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Study Management ↦ Contract

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