What is it? Why is it important?
A risk-based approach is a decision-making process that takes into consideration ways to identify, evaluate, manage and control risks associated with some undertaking, such as a study.
Managing risks requires them to be prioritised based on expected risk occurrence and potential negative impact.
The aim is to allocate often-limited resources by implementing risk mitigation actions in areas where they are most likely needed. With the aim to prevent or mitigate the negative impact of a risk.
A risk based-approach means to:
- Identify potential risks (e.g. risks introduced by implemented study processes and procedures)
- Evaluate risks based on their likelihood of occurrence, ability to be detected and expected impact
- Prioritise risks, and define risk reduction & mitigation measures proportionate to risk significance
A risk based-approach means to:
- Communicate and train staff on those risk mitigation measures
- Review risk control measures in order to test its ongoing efficiency
- Document implemented risk control measures, potential deviations and improvement procedures
What do I need to do?
Familiarise yourself with how to identify, evaluate and understand potential study risks.
Focus should be on risks that result from the implementation of the study.
Assess how these risks impact the:
- Safety and well-being of study participants
- The quality and integrity of study data
- Study significance and public interest when compared to potential research competitors
- Overall study quality aspects (e.g. staff and resources)
Upon risk identification, implement appropriate measures in accordance with the level of risk.
Consider potential risks when planning a study.
The Swiss law defines risks based on a risk category scale and type of intervention.
- Studies under ClinO:
- Medicinal products: Category A, B and C with category C having the highest risk
- Medical Device: Category A and C, with category C having the highest risk
- Other clinical trial: Category A and B, with category B having the highest risk
- Decisions regarding target population:
- Adults, children, adolescents
- Participant with or without capacity in the involvement of the consent procedure
- Participants in an emergency situation
- Type of intervention:
- With or without expected direct benefit
- With or without minimal risks and burdens
Depending on risk, the potentially required risk management and its potential strategy within a given study can vary greatly.
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 for quality management
ISO 31000 – see in particular section
- Risk management: Principles and guidelines (access liable to costs)
HRA – see in particular article and chapter
- Art. 12 Risks and burdens
- Chapter 3 Requirements for research involving vulnerable persons