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 evaluated and 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. It aims to prevent or mitigate the negative impact of a risk.
A risk based-approach means to:
- Identify potential risks (e.g. during protocol development and the identification of critical study processes)
- 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-basedapproach means to:
- Communicate and train staff on those risk mitigation measures
- Review risk control measures in order to check its ongoing efficiency
- Document implemented risk control measures, potential deviations and improvement procedures
Applying a risk-based approach provides the opportunity to focus on the most risk relevant tasks needed to conduct a study (e.g. the protection of study participants and the integrity of study data)
What do I need to do?
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)
- Example of risk categorisation in ClinO studies:
- Medicinal product studies have risk categories A, B and C, with category C having the highest risk
- Other clinical trial studies have risk categories A and B, with risk category B having the highest risk
- Risks depend on target population, with consenting adults having the lowest risk compared to vulnerable populations:
- Children and adolescents
- Participant without capacity
- Participants in an emergency situation
- Risks are assessed based on type of intervention, such as studies:
- With or without expected direct benefit
- With or without minimal risks and burdens
Depending on risk, the 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, 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 guideline
- 5.0 for quality management
ISO 31000 (access liable to costs) – see in particular section
- Risk management: Principles and guidelines
HRA – see in particular article and chapter
- Art. 12 Risks and burdens
- Chapter 3 Requirements for research involving vulnerable persons
ClinO – see in particular article
- Art. 19 Categorisation of studies with medicinal products