What is it? Why is it important?

Risk control measures are steps implemented by the SP-INV in order to reduce the likelihood of risk exposure.

Upon evaluating and prioritising risks the SP-INV decides whether a risk should be:

  • Accepted: no preventative measures required
  • Tolerated: as long as impact remains within predefined boundaries
  • Reduced: introduction of mitigating measures
  • Prevented: implement measures to avoid risk occurrence all together

More

  • Risk tolerance describes the willingness to accept a certain amount of threat or danger associated with a task or situation
  • In studies, participant protection and reliability of study results must be insured. Thus, risk control measures are adapted accordingly
  • Ideally, risk control-measures target the root cause of a risk. This will most effectively prevent or reduce the likelihood of risk occurrence
  • Any deviation from predefined tolerance limits should trigger the re-evaluation and possible adaptation of preventative measures

Example

In a blinded vaccine study, Placebo & Vaccine syringes look exactly similar. Only identifier is vial coding, identifying them as either placebo or vaccine.

Risk: Mix up of placebo and vaccine syringes. This will affect study outcome.

Measures: SP-INV recognises risk and proposes measures to mitigate risk occurrence:

  • Placebo and vaccine syringes are stored in separate sections of the fridge or in 2 separate fridges
  • Consensus between identifier (placebo or vaccine) and syringe code is always done according to a 4-eye/double-check principle

What do I need to do?

Envision an example from daily life (e.g. falling while walking on frozen pavement).

Train yourself in defining risk control measures:

  • Risk acceptance: accept to walk on the frozen pavement
  • Risk tolerance: accept to walk on frozen pavement considering that there is at least a certain amount of snow. Threshold is a “certain amount of snow”
  • Risk reduction: such as add salt or gravel on frozen pavement, wear crampons.
  • Risk avoidance: such as take a taxi, remain inside

More

Based on the REM risk control measures:

  • Must be implemented for risks located on the top right-hand corner of the diagram (high frequency, high impact)
  • Should be defined, set-up and tested for robustness prior to study start. This ensures efficiency of control measures during study conduct
  • Can be implemented on several levels, such as

If you assess the impact of a risk, ask yourself whether this event would put patients or the study outcome in danger.

You can learn a lot about risks and how to manage them from lessons learned during previous studies. Thus, document implemented control measures and their efficacy in a risk management plan. The plan can be used as a basis for later studies.

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
  • 5.0.4 Risk control

ISO 31000 – see in particular section

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

Documents

Abbreviations
  • CTU – Clinical Trials Unit
  • REM – Risk Evaluation Matrix
  • SP-INV – Sponsor-Investigator
Basic ↦ Quality and Risk ↦ Risk Management ↦ Definition Risk Control Measures
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): Basic ↦ Quality and Risk ↦ Risk Management ↦ Definition Risk Control Measures

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