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:

Budget:

Participant recruitment:

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

Resources and processes:

Biobanking

Where can I get help?

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

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

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
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
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 Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
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.