What is it? Why is it important?
The risk assessment tool (RAT) is a supporting document that helps the SP-INV to identify, rate and document potential study risks. The tool gives guidance on how to estimate risk occurrence, its impact, including required risk control measures.
Study risk assessment starts during study feasibility assessment and protocol development.
The RAT summarises:
- Identified risks (e.g. based on complexity of study design, target group, site feedback)
- Defined risk control measures (e.g. monitoring scope, preventative measures)
When writing the study protocol, an estimation of potential study risks and their mitigating factors are defined. Still, risk adaptations might also become necessary during study conduct.
Consequently, risk identification and handling (evaluation, prioritisation, definition of control measures) is a continuous process, starting at the time of protocol writing and only ending upon study completion.
The RAT is a living document, which has to be evaluated regularly during study conduct.
What do I need to do?
During risk assessment:
- Perform an initial risk evaluation and define applicable risk control measures
- Place special attention on risks potentially impacting participant protection and quality of study data
- Include experts able to assist in risk assessment and control
- Include risks identified during feasibility assessment
- Document all information in the RAT
Identified risks may require an increase in budget, time or resources in order to mitigate or prevent their occurrence. These aspects must be considered when writing up the study budget.
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 guideline
- 5.0 Quality management
ISO 31000 – see in particular section
- Risk management: Principles and guidelines (access liable to costs)