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)
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
- 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 multi-centre study must be submitted to the EC.
For more information refer to Protocol in this Study Guide.
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
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
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