What is it? Why is it important?

Risk identification addresses the question: What can go wrong in my study?

Identifying study-risks allows the SP-INV to plan for applicable control measures needed for effective risk management.

Risk identification is made at:

  • System level: e.g. infrastructure, procedures, electronic equipment, service providers, work space
  • Staff: e.g. availability, conflict of interest, qualification, including level of experience and training
  • Study level: e.g. trial design, data collection, participants, IMP/MD
  • Scientific level: e.g. competitors, relevancy

 

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Examples of what can go wrong:

  • Staff: untrained personnel, lack of staff back-up, inadequate time at disposal for study implementation
  • Safety: no directives for the assessment and documentation of adverse events, SAE, SUSAR
  • Data protection: participant data is accessible to staff not involved in the study
  • Participant right: not properly informed regarding study withdrawal
  • Data quality: data is incomplete, not fit for final analysis
  • Analysis: statistics not applicable for data evaluation
  • Design: feasibility is questionable resulting in poor participant and staff compliance, study question is not relevant
  • Biological material: lack of quality processes for sample retrieval, handling and storage

What do I need to do?

Train yourself:

  • Based on daily practice identify current risks, such as
    • Error in drug dosing
    • Loss of biological samples
    • Time needed for administrative work
    • Staff qualifications and fluctuations
  • Apply the same reasoning to clinical research activities:
    • Patient rights, safety and well-being
    • Integrity and quality of study results
    • Handling of IMP/MD

More

Consider critical circumstances and processes with inherent risks:

  • Study design, such as randomised-, blinded- or cross-over design, required wash-out period
  • Study participants, such as healthy volunteers, vulnerable participants such as pregnant women or children, expected study compliance, drop-outs, lost to follow up
  • Type of intervention, such as invasive or non-invasive procedures, carried out to improve, maintain or assess participant health
  • Methodological aspects, such as identification of treatment(s) and outcome used, statistical power used to test study hypothesis
  • IC process, such as emergency situations, high recruitment numbers, non-native speakers
  • Multi-centre studies, such as coordination and proficiency of participating sites
  • Study partners, such as proficiency and ability to deliver requested services
  • Informatics e.g. access, data privacy protection, data back-up
  • Study staff, such as available resources, know-how, training, available time to dedicate to the study

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 guidelines

  • 5.0 Quality management
  • 5.0.2 Risk identification

ISO 31000 – see in particular section

  • Risk management: Principles and guidelines (access liable to costs)

Documents

Abbreviations
  • CTU – Clinical Trials Unit
  • IC – Informed Consent
  • ICH GCP - International Council for Harmonisation Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product / Medical Device
  • ISO - International Organization for Standardization
  • SAE – Serious Adverse Event
  • SUSAR – Suspected Unexpected Serious Adverse Reaction
Basic ↦ Quality and Risk ↦ Risk Management ↦ Definition Risk Identification
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 Identification

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