What is it? Why is it important?

Lessons learned are important experiences and observations gathered during study conduct that could be very useful to improve the management of subsequent studies. The aim is to repeat experiences that were fruitful and avoid those that were not.


Thus, already during study conduct but certainly upon study termination a retrospective evaluation of the study should be performed. Experiences both positive and negative gathered during earlier studies could greatly benefit the successful planning and conduct of future studies.

What do I need to do?

As a SP-INV, assess upon study closure aspects such as the:


Participant recruitment:

  • Were adequate eligible participants available?
  • Were timelines and processes respected?

Resources and processes:


Where can I get help?

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

  • CTU – Clinical Trials Unit
  • SOP – Standard Operating Procedures
  • WI- Working Instructions
Completion ↦ Management ↦ Study Closure ↦ Lessons Learned

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 Statistic Methodology
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 Statistic Methodology
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 Statistic Methodology
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Completion ↦ Management ↦ Study Closure ↦ Lessons Learned

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