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:


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.


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.


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 CTU can support you with experienced staff regarding this topic


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 Requirements for research involving vulnerable persons

ClinO – see in particular article

  • Art. 19 Categorisation of studies with medicinal products


  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • HRA – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • QMS – Quality Management System
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
Basic ↦ Quality and Risk ↦ Risk Management Definitions ↦ Risk-Based Approach

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

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

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