What is it? Why is it important?

Risk control measures are decisions taken by the SP-INV based on risk evaluation and prioritisation including respective actions to be taken, such as to:

  • Accept a risk: no measures required
  • Tolerate a risk: no measures taken as long as risk remains within a predefined limit
  • Reduce a risk: mitigation measures taken
  • Prevent a risk: measures taken to avoid risk occurrence all together

If the decision is to tolerate a risk, any deviation from predefined tolerance limits should trigger a re-evaluation and potential implementation of new mitigating measures.

Ideally, risk control-measures target the root cause of a risk. Knowing the cause of a risk can prevent or reduce the likelihood of its occurrence.

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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?

For each risk:

  • Decide whether you want to accept, tolerate, reduce or prevent a risk altogether
  • Depending on how you decide to handle a risk define applicable measures. Consult relevant experts
  • Implement and test the efficacy of your measures and make appropriate adaptations
  • Explain preventative measure and how they are implemented to the study staff and train accordingly
  • Complete the RAT

More

Throughout all study stages, the SP-INV is responsible to implement a risk-based QMS.

Control-measures can be an individual measure or a combination of various measures, with the involvement of different staff members.

Methods used to assure and control quality risks should be proportionate to the expected inherent risk to the study.

Examples of risk control-measures:

  • Study protocol: use an appropriate study design, structure and provide guidelines for data collection activities, avoid unnecessary data collection and over the top study designs
  • Staff trainings: give detailed guidance on procedures in the form of processes, SOPs, WIs, or other applicable documents
  • Supervision: provide ongoing personal support to project manager and study coordinators
  • Infrastructure & functionality: adapt eCRF to be user friendly, provide required specialised analytical material, ensure appropriate premises are available
  • Additional tasks: use double-data entry, implement supervision with 4-eyes principle, check independence of outcome assessments, select central- or on-site monitoring

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
  • eCRF – electronic Case Report Form
  • QMS – Quality Management System
  • RAT – Risk Assessment Tool
  • SOP –Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
Development ↦ Quality and Risk ↦ Study Risk Management ↦ 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): Development ↦ Quality and Risk ↦ Study Risk Management ↦ Risk Control Measures

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