Basic↦Quality and Risk↦Risk Management Definitions↦Risk Control Measures
Was betrifft es? Warum ist das wichtig?
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
Was muss ich befolgen?
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.
Wo kann ich Hilfe anfordern?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), 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