What is it? Why is it important?

Risk evaluation asks:

  • What is the likelihood that an error occurs?
  • The extent and threshold at which an error can be detected?
  • What impact will an error have on participant safety and data quality?

Risk prioritisation asks:

  • Based on risk evaluation, how should a risk be prioritised - high-, medium-, low- risk to the study?
  • How will risk-priority affect the requirement of preventative measures?

It is the responsibility of the SP-INV to evaluate and prioritise study risks

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It is the responsibility of the SP-INV to evaluate and prioritise study risks

What do I need to do?

Based on high-, medium-, and low scale evaluate for each identified study risk:

  • The likelihood of risk occurrence
  • Their impact on participant protection and data quality

Prioritise your risks:

  • Draw up a REM diagram
  • Focus on risks based on their position in the REM diagram

1. High risk and high impact– top priority

2. High impact and low risk – medium priority

3. Low impact and high risk – medium priority

4. Low impact and low risk – low priority

More

Irrespective of risk position within the REM additional individual risk ratings might become necessary to decide where it is most advisable to invest resources (e.g. study staff, infrastructure, 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 guidelines

  • 5.0 Quality management
  • 5.0.3 Risk evaluation

ISO 31000 – see in particular section

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

Documents

  • Risk Assessment Tool (RAT) – Template: A tool to assess study risks
  • Risk Evaluation Matrix (REM) – a grid: helps to categorise and prioritise study risks
  • Monitoring Plan – Template: Documents the study monitoring strategy
Abbreviations
  • CTU – Clinical Trials Unit
  • REM – Risk Evaluation Matrix
  • SP-INV – Sponsor-Investigator
Development ↦ Quality and Risk ↦ Study Risk Management ↦ Risk Evaluation and Prioritisation
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): Development ↦ Quality and Risk ↦ Study Risk Management ↦ Risk Evaluation and Prioritisation

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