What is it? Why is it important?

Lessons learned are insights, new knowledge and experience acquired during study conduct.


It requires that:

  • Study staff members are aware of the importance of newly acquired experience and knowledge
  • The SP-INV or Site-INV ensures that any new insights are appropriately documented and made available for consultation during future studies


Experiences can be both positive and negative. Either way, both types of experiences can be translated into “lessons learned”.

What do I need to do?

As a SP-INV or Site-INV, ask yourself upon study conclusion:

  • Was the study risk management appropriate, given the complexity of the study?
  • Which control-measures were highly effective, which ones did not adequately prevent risk occurrence?
  • From a risk management perspective, how was the study able to profit considering the safety of study participants and the quality of study data ?
  • How can I most effectively integrate "lessons learned" in the risk-based QMS of future studies?


The RAF is an excellent source of information regarding the established risk management and risk strategy of a completed study. This will only be possible if all risk activities were diligently documented during study development, set-up, and conduct. 

Where can I get help?

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


ICH GCP E6(R2) – see in particular guideline

  • 5.0 Quality management

ISO 9001 – see in particular section

  • QMS Requirements (access liable to costs)


  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organization for Standardization
  • QMS – Quality Management System
  • RAF - Risk Assessment Form
Completion ↦ Quality and Risk ↦ Clinical Study Report ↦ 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 ↦ Quality and Risk ↦ Clinical Study Report ↦ Lessons Learned

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