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:

More

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.

More

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

References

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)

Swiss Law

HRA – see in particular article and chapter

  • Art. 12 Risks and burdens
  • Chapter 3 Requirements for research involving vulnerable persons

Document

Documents

Abbreviations
  • CTU – Clinical Trials Unit
  • ClinO – Clinical Trials Ordinance
Basic ↦ Quality and Risk ↦ Risk Management ↦ Definition Risk-Based Approach
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Quality and Risk ↦ Risk Management ↦ Definition Risk-Based Approach

Please note: the Easy-GCS tool is currently under construction.