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.

Multi-centre studies:

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

Service providers:

  • 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)

More

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)

Ask yourself:

  • 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?

More

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

External LinksSwissethics - see in particular

  • Template for clinical study agreement

References

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
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • IMP – Investigational Medicinal Product
  • Site-INV – Investigator
  • SP-INV – Sponsor-Investigator
Concept ↦ Management ↦ Resources ↦ Partners
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Concept ↦ Management ↦ Resources ↦ Partners

Please note: the Easy-GCS tool is currently under construction.