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), laboratory analysis, 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 provided based on quality standards. If applicable, request quality certificates (e.g. certified laboratories, Site-INV, GCP training)
  • Ensure that services are performed according to the study protocol, GCP, and regulatory requirements
  • Perform regular checks to ensure ongoing quality of rendered services, including ongoing compliance of all involved parties (e.g. the SP-INV can perform an audit or monitoring visit at partner site)

More

Quality checks can cover service providers:

Perform audits at partner institutions in order to verify the correct handling and operation of services, including material production and delivery.

Multicentre Studies:

  • Prior to study start: Perform site-feasibility checks in order to evaluate whether a site fulfils SP-INV requirements for study participation.
  • During study conduct: Perform regular monitoring visits at the site to ensure compliance with study protocol, GCP and regulatory requirements

What do I need to do?

Carefully select potential partners.

Service providers:

  • What kind of services must be outsourced?
  • Does the hospital provide applicable services?
  • What is the cost benefit ratio among providers?
  • How can the quality of services be evaluated and guaranteed?

Multicentre studies does the site have:

  • Qualified personnel?
  • Sufficient eligible participants for the study?
  • Disposable time for study investment?
  • Required infrastructure?

Hired services cost money. Remember to make appropriate budgetary adjustments.

More

It might be an advantage to initially 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)

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 - see in particular section (access liable to cost)

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

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