What is it? Why is it important?
Partners are the inclusion of additional study sites, or external service providers needed for the successful planning and conduct of a study.
Additional study sites are usually recruited in order to have access to:
- Study required expertise (e.g. hospital departments from another region in Switzerland, general or specialist practitioner
- An increased number of study participants
Service providers can either be:
- 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 with partners, the delegation of tasks including respective responsibilities must be clearly defined. For this purpose a contract should be set-up and mutually approved.
What do I need to do?
As a SP-INV, assess the need for partners with respect to required:
- Expertise (e.g. radiological assessments, specialised analysis, pharmacy for the preparation of IMP and/or placebo)
- Participating study sites in order to gain expertise and access to an additional number of participants (e.g.)
- Services (e.g. project management, statistics, data management, monitoring, study nurse)
- During which phase(s) do I need support (e.g. study set-up, conduct, and/or completion)?
- Do study staff members already have the needed expertise, or can I train them on required services?
- How does the involvement of partners affect my study budget?
Final study budget depends on study design and type (e.g. ClinO, ClinO-MD, Other clinical trials, HRO). The level of partner involvement and the extent of their provided services will significantly affect the budget. Contact service providers for a cost estimate, and ensure these expenses are included.
Example of partner involvement inflating study costs
- Inclusion of additional study sites in a multi-centre study
- Inclusion of different language regions, requiring the translation of study documents (e.g. Informed Consent Form, Patient Information)
- Selection of national or international vendors or service providers (e.g. laboratories, study material)
- Outsourced required study services, (e.g. project management, data management, monitoring, statistics, storage and handling of biological samples)
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