What is it? Why is it important?

Lessons learned are important experiences that should be kept in order to improve the management of subsequent studies.

Thus, upon study termination a retrospective evaluation of the study conduct should be performed in order to repeat experiences that were fruitful and avoid those that were not.

With a critical assessment of the lessons learned. Experiences both positive and negative gathered during earlier studies can greatly benefit the successful planning and conduct of future studies

What do I need to do?

Aspects to assess upon study closure are:


Participant recruitment:

  • Were adequate eligible participants available?
  • Was timeline and processes respected?

Resources and processes:

  • Was study staff sufficiently qualified for study responsibilities? Was there adequate time at disposal?
  • Was infrastructure satisfactory?
  • Did study SOPs, WIs, processes, including various study documents support study planning and conduct?
  • Were processes or documents implemented, which could have been skipped as those did not result in substantial improvement?
  • Was the monitoring adequate and resulted in increased data quality and patient protection?
  • Were Data Management processes adequate?

Where can I get help?

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

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

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): Completion ↦ Management ↦ Study Closure ↦ Lessons Learned

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