What is it? Why is it important?

The Risk Assessment Form (RAF) is a supporting document that helps the SP-INV to identify, rate and document potential study risks. The tool gives guidance on how to estimate risk occurrence, its impact, including the implementation of required risk control-measures.


Study risk assessment starts during study feasibility assessment and protocol development.


The RAF documents:


Risk adaptations might also become necessary during study conduct. Consequently, risk identification and management (evaluation, prioritisation, definition of control measures) is a continuous process, starting at the time of protocol writing and only ending upon study completion. The RAF is a living document regularly evaluated during study conduct.

What do I need to do?

As a SP-INV perform a risk assessment of your study:

  • Identify the potential study risks and define applicable risk control-measures
  • Place special attention on risks impacting the safety of your study participant and the quality of study data
  • Include experts able to assist in risk assessment and control
  • Include risks identified during the feasibility assessment and study conduct
  • Document all information in the RAF


Identified risks may require an increase in budget, time, and resources needed to mitigate or prevent their occurrence. These aspects must be considered when writing up the study budget.

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

  • Risk management: Principles and guidelines



  • 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
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instruction
Concept ↦ Quality and Risk ↦ Study Feasibility ↦ Risk Assessment Form

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

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

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device

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): Concept ↦ Quality and Risk ↦ Study Feasibility ↦ Risk Assessment Form

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