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 vials are identical only distinguishable through an 8 digit identifier placed on the vial.
Risk: mix-up of placebo and vaccine vials which will threaten study outcome and endanger the safety of study participants (e.g. unwanted side effects are falsely attributed to the treatment intervention)
Risk Control-Measures: the study SP-INV recognises the risk and proposes measures to mitigate risk occurrence.
- RCM 1: placebo and vaccine vials are stored in separate sections of the fridge or in 2 separate fridges
- RCM 2: consensus between vial identifier list (placebo or vaccine) and the 8-digit identifier on the retrieved vial are checked and confirmed based on a 4-eye/double-check principle (e.g. 2 persons agree and confirm the correct vial identifier)
What do I need to do?
As a SP-INV you are responsible to define risk control-measures according to risks defined in your study.
For each risk:
- Decide whether you want to accept, tolerate, reduce or prevent a risk altogether
- Depending on how you decide to manage a risk, define applicable control-measures. Consult relevant experts for support (e.g. study staff, quality manager, lab personnel)
- Plan control-measures proportionate to the expected significant impact of a potential risk (e.g. impact on the primary- or secondary study endpoint(s))
- Implement and test the efficacy of your control-measures and make appropriate adaptations
- Document risk control-measures in the Risk-Assessment-Form (RAF) of the study, and ensure all study staff is trained on its implementation
A RCM can be a single measure or a combination of different measures, with the involvement of different staff members, even departments (e.g. surgery, study staff, laboratory).
Examples of risk control-measures:
- Study protocol: use an appropriate study design by abstaining from over the top-designs which increases complexity and risk occurrence. Avoid unnecessary data collection that challenges available resources (e.g. study staff, infrastructure, budget)
- Study Documents: provide guidelines for study relevant procedures such as data collection, informed consent, handling of IMP/IMD (e.g. SOPs, WIs)
- Staff trainings: ensure study staff is trained on the risk-based QMS of your study (e.g. risk management)
- Monitoring: follow-up on implemented risk control-measures during study conduct and the potential for novel risk occurrence(s). Consider quality assurance and quality control aspects.
- Infrastructure & functionality: adapt eCRF to be user friendly, provide required specialised analytical material, ensure appropriate premises are available
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
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