Your Easy Guide to Clinical Studies

Partners are the inclusion of additional study sites, or external service providers needed for the successful planning, conduct, and archiving of a study.

 

Multi-centre studies:

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.

 

Contracts between a SP-INV a grant provider or partners are submitted to Ethics Committee (EC) for approval. This includes contracts between the SP-INV and Site-INV in a multi-centre study.

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 the Investigational Medicinal Product (IMP) and/or placebo)
• Additional participating study sites, to gain needed expertise and access to an increased number of participants
• Selected services (e.g. project management, statistics, data management, monitoring, study nurse)

 

Ask yourself:

• During which study 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 amount of partners involved, 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.

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External Links

swissethics - see in particular

• Template for clinical study agreement

References

ICH GCP E6(R3) – see in particular guidelines

• 3.6 Agreements
• 3.5 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