What is it? Why is it important?

In a laboratory results are generated that are needed for the evaluation of the study.

Laboratory results can contribute:

  • To answer the primary (secondary) question(s) of the study
  • To evaluate participants safety during study conduct (e.g. threshold values for decision regarding study continuation)

Running a laboratory requires:

  • Professionally trained staff and leadership
  • Ongoing maintenance of analytical equipment (e.g. centrifuge, haematology-, chemistry analysers, freezers)
  • A quality management system with applicable SOPs, WIs, staff trainings, risk management, emergency- and improvement plan

What do I need to do?

When outsourcing analytical services to partners:

  • Define type of analysis required
  • Select a laboratory based on required experience, including applicable accreditations with respect to provided services
  • Request accreditation certificates
  • In multi-centre studies it is recommended to use a central laboratory. If this is not possible, make a plan on how to manage these different laboratories, and ensure results will be comparable
  • Define responsibilities in a joint contract, including potential publication rights


Laboratory maintenance and management activities must be documented in order to guarantee reproducibility of results.

To obtain comparable results in a multi-centre study a central laboratory is recommended.

Where can I get help?

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


EMA - see in particular

  • Good laboratory practices (GLP)
  • CTU – Clinical Trials Unit
  • EMA – European Medicines Agency
  • GLP _ Good Laboratory Practise
  • SOP – Standard Operating Procedures
  • WI – Working Instructions
Set-Up ↦ Management ↦ Laboratory ↦ Aim

Provides some background knowledge and basic definitions

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

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

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

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
Set-Up Biobanking

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

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): Set-Up ↦ Management ↦ Laboratory ↦ Aim

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