Basic↦Quality and Risk↦Risk Management Definitions↦Risk Control Measures
What is it? Why is it important?
Risk control-measures are steps implemented by a study SP-INV / Site-INV, or project-leader of a HRO research project, in order to reduce risks to an acceptable level, including the likelihood of risk occurrence altogether.
Upon risk evaluation & prioritisation, a decision is taken whether a risk should be:
- Accepted: no preventive measures required
- Tolerated: as long as impact remains within predefined boundaries. Risk tolerance describes the willingness to accept a certain amount of threat or danger associated with a task or situation
- Reduced: introduction of mitigating measures. In studies, participant safety and the quality of study data must be guaranted
- Prevented: implement measures to avoid risk occurrence
Ideally, risk control-measures target the root cause of a risk, as this approach 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 preventive measures.
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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?
As a SP-INV, Site-INV, or HRO project-leader, 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 to add salt or gravel on frozen pavement, wear crampons
- Risk avoidance: such as to take a public trasport instad of walking or remain inside
When assessing the impact of a risk, ask yourself how it could potentially jeopardize the safety of your study participants and / or the quality of your study data.
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Based on the REM risk control measures:
- Are especially crucial for risks on the top right-hand corner of the diagram (e.g. high risk frequency with high impact)
- Are tested for robustness prior to study start to ensure efficacy during study conduct
- Can be implemented on several levels, such as
- Study design
- Extent and scope of study monitoring
- Delegation of roles & responsibilities
- Planned training of study staff
- Infrastructure adaptations
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
References
ICH GCP E6(R2) – see in particular guidelines
- 5.0 Quality management
- 5.0.4 Risk control
ISO 31000 (access liable to costs) – see in particular section
- Risk management: Principles and guidelines