What is it? Why is it important?

The risk assessment tool (RAT) 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 required risk control measures.

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

The RAT summarises:

  • Identified risks (e.g. based on complexity of study design, target group, site feedback)
  • Defined risk control measures (e.g. monitoring scope, preventative measures)

More

When writing the study protocol, an estimation of potential study risks and their mitigating factors are defined. Still, risk adaptations might also become necessary during study conduct.

Consequently, risk identification and handling (evaluation, prioritisation, definition of control measures) is a continuous process, starting at the time of protocol writing and only ending upon study completion.

The RAT is a living document, which has to be evaluated regularly during study conduct.

What do I need to do?

During risk assessment:

  • Perform an initial risk evaluation and define applicable risk control measures
  • Place special attention on risks potentially impacting participant protection and quality of study data
  • Include experts able to assist in risk assessment and control
  • Include risks identified during feasibility assessment
  • Document all information in the RAT

More

Identified risks may require an increase in budget, time or resources in order 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

References

ICH GCP E6(R2) – see in particular guideline

  • 5.0 Quality management

ISO 31000 – see in particular section

  • Risk management: Principles and guidelines (access liable to costs)

Documents

Abbreviations
  • CTU – Clinical Trials Unit
  • RAT – Risk Assessment Tool
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Concept ↦ Quality and Risk ↦ Study Feasibility ↦ Risk Assessment Tool
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
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
Development Biobanking
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 Drug or Device
Set-Up Biobanking
Conduct

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
Completion

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

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