Development↦Management↦Study Management↦Contract
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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