What is it? Why is it important?
Partners are additional study sites or external service providers needed for the successful planning and conduct of a study.
Additional study sites recruited in order to get increased access to study relevant expertise and study participants, such as:
- Hospital departments from another region in Switzerland
- General or specialist practitioner
- Hospital internal partners: department of pathology, radiology, laboratories, pharmacy and (local) clinical trials units
- Hospital external partners: vendors providing selected services, materials, expertise (e.g. monitoring, statistician, data manager, insurance companies)
When working together with partners, the delegation of respective responsibilities must be clearly defined.
Agreements should be documented in a mutually approved contract. Negotiations can be very time consuming. Services can only start once the agreement is signed.
Contracts between SP-INV and grant provider or partners have to be submitted to EC for approval. This would also be the case in a multicentre study. Here the contract is between the SP-INV and each Site-INV.
What do I need to do?
In addition to existing resources and infrastructure, assess the need for partners, such as:
- Expertise (e.g. project management, statistics, data management)
- Collaborations, (e.g. study sites, preparation of IMP and/or placebo)
- Services (e.g. monitoring, study nurse)
- Facilities (e.g. offices, patient rooms, laboratories, storage of biological material)
- During which phase(s) do I need support (e.g. study set-up, conduct, and/or completion)?
- Can I train current staff to provide required services?
- How will it affect my budget?
Final study budget depends on study design, type of partner(s) involved and their location, such as:
- Multi- versus mono-centre studies may include several EC regions
- Inclusion of different language regions, which requires translation of ICF and study documents, and possibly different EC regions
- Selection of national or international vendors or service providers (e.g. laboratories, study material) will increase or decrease cost depending applicable fees and extent of requested services
- Type and amount of required hired services, (e.g. project management, monitoring, analysis of biological samples, statistical analysis)
- Requirement for handling and storage of biological material (e.g. shipment, storage surveillance)
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
- Template for clinical study agreement
ICH GCP E6(R2) – see in particular guidelines
- 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 costs)
- 6.9 Agreement(s)
- 9.3 Outsourcing of duties and functions