Your Easy Guide to Clinical Studies

A contract is a written, dated, and signed document between two or more parties. The contract delineates delegated tasks, outlines corresponding responsibilities, and defines the financial aspects.

 

Partner contracts are establised with:

• Outsourced service providers:
  • Hospital internal services (e.g. pathology, radiology, laboratories, pharmacy)
  • Hospital external services, such as vendors providing selected study services, materials, and expertise (e.g. laboratories, monitoring, statistics, data management, insurance companies)
• Study sites of a multicentre study: are studies with more than one study site (i.e. irrespective of language region)

 

Contract development can include many players:

• The SP-INV of the study
• Hospital legal department
• Hospital management
• Partner representatives (e.g. additional study sites, laboratory, monitoring, data management, statistical services)
• Partner legal department

As a SP-INV, consider the following aspects when drafting the contract:

• Type of service requested
• Nature of the collaboration
• Respective tasks and responsibilities
• Expected timeline of provided service, including milestones
• Financial agreement, including a payment plan. Pay-outs can be planned in a step-like manner, such as after reaching a study milestone (e.g. upon Ethics Committe (EC) approval or after inclusion of a set number of participants).
• The confidentiality agreeement
• Publication rights
• The handling of legal disputes

 

A contract is reviewed and approved by the:

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

 

Allow ample time for contract development. Given the involvement of multiple parties, approval may take a considerable amount of time.

 

Signed contracts between the SP-INV and the grant provider(s) or the Site-INV(s) in a multi-centre study must be submitted to the Ethics Committee (EC).

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 (access liable to cost) - see in particular sections

• 6.9 Agreements
• 9.3 Outsourcing