What is it? Why is it important?
- 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.
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
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
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
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)