What is it? Why is it important?

Outsourced services are specific study tasks that have been delegated to study partners (e.g. Site-INV(s), laboratories, study monitoring). Partners must be qualified by education and training to perform these study services.

 

It is the responsibility of the SP-INV to:

  • Select qualified partners
  • Ensure services are based on quality standards. If applicable, request quality certificates (e.g. certified laboratories, ISO certified service providers)
  • As applicable, ensure that services are performed according to the study protocol, required guidelines (e.g. GCP, ISO 14155, ISO 20916), and regulatory requirements (e.g. Swiss law)
  • Perform regular checks in order to ensure ongoing compliance and quality of rendered services (e.g. perform an audit or monitoring isit at partner sites)

What do I need to do?

As a SP-INV, carefully select potential partners needed for the implementation of your study.

 

Based on yours study ask yourself:

  • What kind of services need to be outsourced?
  • Does the hospital provide applicable services? Check availability of hospital internal service providers. These providers might already have relevant study experience, have shorter communication lines and can be more cost effective (e.g. local CTU)
  • What is the cost-benefit ratio among providers? Hired services cost money. Remember to make appropriate budgetary adjustments.
  • How can the quality of outsourced services be evaluated and guaranteed? Plan audits at partner institutions in order to verify the correct handling and operation of services, including material production and delivery.

 

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guideline

  • 5.2 Contract Research Organization (CRO)

 

ISO 14155:2020 Medical devices (access liable to cost) - see in particular section

  • 9.3 Outsourcing of duties and functions
Abbreviations
  • CTU – Clinical Trials Unit
  • GCP – Good Clinical Practice
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Management ↦ Outsourced Services
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
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
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 Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Study Management ↦ Outsourced Services

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