Conduct↦Quality and Risk↦Risk Review↦Re-Evaluation
What is it? Why is it important?
During risk reviews, risk control-measures are re-evaluated in order to ensure that they remain effective and whether new or additional measures are required.
Questions to ask during a risk review:
- Have new unanticipated risks been identified?
- Have old risks become less relevant?
- Do current risk control-measures remain effective or must they be replaced or improved?
- Are risk-control measures still relevant with respect to emerging knowledge and expertise?
- Is study staff up-to-date and trained on current risk control-measures?
Risk review is an interactive process between those implementing risk control-measures, and those deciding what control-measures to implement.
Only with a communicative feedback loop can it be guaranteed that quality control-measures remain appropriate and effective.
What do I need to do?
As a SP-INV or Site-INV implementing the SP-INV's risk strategy, perform regular risk reviews:
- Collect regular staff feedback and re-evaluate the robustness of current Quality Control (QC) measures (e.g. monitoring, process verification and training)
- Decide whether risk control-measures must be adapted, improved, or even deleted
- Keep vigilance regarding deviations from predefined risk tolerance limits
- Trigger automatic risk reviews
- If a risk deviates from predefined quality tolerance limits
- When implementing new risk control-measures
- Schedule regular staff meetings to discuss the risk management of the study and train staff accordingly
- Document the risk review in the Risk Assessment Form (RAF)
Example of a periodic risk review and its re-evaluation process
Protocol requirement: Lab analysis must be performed on fasting blood samples.
Risk: participants are not fasting
- 1st Control-measure: participant is informed at study inclusion regarding fasting state at blood draw
- 1st Periodic risk review: 25% of participants provide no fasting blood
- 1st Risk re-evaluation: 25% surpasses predefined tolerance limit of 10%. Control measures must be adapted
- 2nd Adaptation of control measures: Participants are reminded by SMS on the evening before blood draw regarding fasting state at blood draw
- 2nd Periodic risk review: 13% of participants provide no fasting blood
- 2nd Risk re-evaluation: 13% acceptable with given conditions. Additional risk control measures are not feasible or too costly if implemented
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
- 5.0.3 Risk evaluation
- 5.0.6 Risk review
ISO 31000 – see in particular section
- Risk management: Principles and guidelines (access liable to costs)