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 (e.g. risk-based approach), emergency- and improvement plan (e.g. emergency plan)

What do I need to do?

As a SP-INV, when outsourcing analytical services to partners:

  • Define type of analysis required
  • Select a laboratory based on required experience, including applicable accreditations with respect to the requested service(s)
  • Request accreditation certificates
  • Define responsibilities in a joint contract, including potential publication rights


In the event of a multi-centre study, 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. Laboratory maintenance and management activities must be documented in order to guarantee reproducibility of results.


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 ↦ Purpose and Requirement

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Set-Up ↦ Management ↦ Laboratory ↦ Purpose and Requirement

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