What is it? Why is it important?

In order to protect study participants and the reliability of study results, the SP-INV identifies risks related to study processes and data handling.

Risk identification is based on:

  • System level: informatics, SOPs, infrastructure, laboratory, available work space, resources such as time and personnel, etc.
  • Study level: study design, target population, data collection, IC process, type of intervention such as randomisation and blinding, etc.

More

Implementing a risk-based QMS means to:

  • Identify potential study risks
  • Evaluate risks based on their likelihood of occurrence, ability to be detected and expected risk impact
  • Prioritise risks, and define risk control measures proportionate to risk significance
  • Communicate and train staff on risk prevention
  • Review risk control measures in order to test its ongoing efficiency
  • Document implemented risk control measures, potential deviations and improvement procedures

The SP-INV is responsible for the risk management of the study.

When writing the study protocol, an estimation of potential study risks and their risk control measures are defined. During study conduct and active handling of the study, risk adaptations might become necessary.

Consequently, risk identification and handling (evaluation & prioritisation, definition of control measures) is a continuous process, starting at the time of protocol writing and only ends upon study completion.

Newly identified risks during study set-up, development and conduct might potentially necessitate a protocol amendment.

What do I need to do?

  • Identify the risks in your study, ask yourself:
    • What can go wrong in my study?
    • What could affect patient rights, safety, well-being?
    • What could jeopardise data integrity, data quality?
  • Document all identified risks and their management in the RAT

 

Examples of study risks or what can go wrong:

  • Safety: non-compliant processes in the assessment and documentation of adverse events SAE, SUSAR
  • Data protection: participant data becomes accessible to non-study staff
  • Participant right: are not properly informed regarding study withdrawal or signing of IC
  • Data quality: data incomplete, unusable for final analysis
  • Analysis: statistics not applicable for data evaluation
  • Design: feasibility is questionable resulting in poor compliance and incomplete dataset
  • Biological material: lack of standardised processes for sample retrieval, handling and storage
  • IMP/MD: lack of applicable storage conditions and access control

More

Use ‘lessons learned’ from previous studies. Previous risk experience can facilitate the risk identification of a planned 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
  • QMS – Quality Management System
  • RAT – Risk Assessment Tool
  • SAE – Serious Adverse Event
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • SUSAR – Suspected Unexpected Serious Adverse Event
Development ↦ Quality and Risk ↦ Study Risk Management ↦ 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): Development ↦ Quality and Risk ↦ Study Risk Management ↦ Risk Identification

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