What is it? Why is it important?

In order to maintain oversight of the risk management of the study, requires that risk reviews including any potential adaptations are documented.


Risk documenation should include:

  • Risk implication and the ongoing effectiveness of risk control-measures based on emerging knowledge and expertise
  • Which risk control-measures were effective and which one did not work
  • The use of automatic triggers and its management (e.g. alarms or technical installations that are triggered once a risk deviates from predefined quality tolerance limits)
  • Information flow between those implementing risk control measures, and those deciding what control measures to implement


By documenting the ongoing risk management of the study, lessons learned can be used for optimising risk management in subsequent studies.

What do I need to do?

As a SP-INV or Site-INV, implement the risk strategy and risk management of your study. Document potential risk adaptations during study conduct in th Risk Assessment Form (RAF):

  • Review all identified study risks
  • Document activities and decisions taken during risk reviews and re-evaluations
  • Include deviations from predefined quality tolerance limits and type of actions taken
  • Based on risk, explain how and whether control measures were adapted:
    • With more severe measures
    • With mitigated measures
    • Unchanged as risk remains bellow tolerance limit

Where can I get help?

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


ICH GCP E6(R2) – see in particular guidelines

  • 5.0 Quality management
  • 5.0.7 Risk reporting

ISO 31000 (access liable to costs) – see in particular section

  • Risk management


  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organization for Standardization
  • RAF – Risk Assessment Form
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Conduct ↦ Quality and Risk ↦ Risk Review ↦ Risk Documentation

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 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 Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Quality and Risk ↦ Risk Review ↦ Risk Documentation

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