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:



Examples of what can go wrong:

  • Staff: untrained/insufficiently trained personnel, lack of staff back-up, inadequate time at disposal for study implementation
  • Safety: no directives for the assessment and reporting of IMP/IMD adverse events, SAE, or 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
  • Documentation: insufficient and incomplete documentation of study related activities
  • Biological material: lack of quality processes for sample retrieval, handling and storage

What do I need to do?

As a SP-INV or Site-INV 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/IMD


Consider critical circumstances and processes with inherent risks:

  • Study design: such as randomised-, blinded- or cross-over design, required wash-out period
  • Study participants: 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
  • Study inclusion and exclusion criteria: such as participant recruitment problems based on challenging criteria
  • 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: such as access, data privacy protection, access to validated systems, data back-up
  • Study staffsuch 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


ICH GCP E6(R2) – see in particular guidelines

  • 5.0 Quality management
  • 5.0.2 Risk identification

ISO 31000 (access liable to costs) – see in particular section

  • Risk management: Principles and guidelines


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

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 Identification

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