What is it? Why is it important?

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

It requires that:

  • Members are aware of the importance of newly acquired knowledge
  • New insights are appropriately documented

Experiences can be both positive and negative. How these experiences are handled translates into “lessons learned”.

What do I need to do?

As a review for future studies, ask yourself:

  • Was the risk management appropriate for the study?
  • Which control-measures were most effective?
  • How did the study profit from a risk management perspective?
  • Which risk management activities should be repeated, which one avoided?
  • What aspects of lessons learned can contribute to an improved future risk based QMS?

By completing the RAT during study set-up and conduct will provide a good summary of defined study risks including mitigating strategies.

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)


  • Risk Assessment Tool (RAT) – Template: A tool to assess study risks
  • CTU – Clinical Trials Unit
  • QMS – Quality Management System
  • RAT - Risk Assessment Tool
Completion ↦ Quality and Risk ↦ Final 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 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 ↦ Final Study Report ↦ Lessons Learned

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