Basic↦Quality and Risk↦Risk Management Definitions↦Risk-Based Approach
What is it? Why is it important?
A risk-based approach is a decision-making process that considers ways to identify, evaluate, manage and control risks associated with an activity, 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, detectability, and expected impact
- Prioritise risks, and define risk reduction & mitigation measures proportionate to risk significance
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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?
As a SP-INV or Site-INV familiarise yourself with how to identify, evaluate, and mitigate potential study risks. The focus should be on risks that occur as a result of the conduct of the study (i.e. implementation of study processes and procedures).
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 risk control measures in accordance with the level of risk.
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Consider potential risks when planning a study. The Swiss law defines risks based on study risk category and type of intervention.
- 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 Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
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
Swiss Law
HRA – see in particular article and chapter
- Art. 12 Risks and burdens
- Chapter 3 Additional requirements for research involving vulnerable persons
ClinO – see in particular article
- Art. 19 Categorisation of studies with medicinal products