What is it? Why is it important?

Depending on study tasks and responsibilities delegated by the SP-INV or Site-INV, study team members:

  • Provide feed-back regarding risk identification
  • Evaluate risks and propose applicable risk control measures
  • Ensure that risk control measures are correctly implemented
  • Provide feedback in the event risk prevention measures do not provide adequate protection against risk occurrence



A nurse at a study site identifies regular delays with monthly drug shipments, causing potential risks in study conduct (e.g. participant recruitment, interruption in study drug treatment). To pre-empt stock outs she proposes risk-control measures by implementing weekly shipments instead.

What do I need to do?

As a SP-INV or Site-INV ensure that study staff members:

  • Are familiar with their delegated roles and responsibilities (e.g. documented in the delegation-log)
  • Have the required education and training
  • Implement the defined risk-strategy of the study (e.g. risk-control-measures, risk review)
  • Provide ongoing feedback on the:
    • Ongoing risk surveillance during study conduct
    • Applicability of implemented risk-control-measures including required adaptations
    • Identification of novel risks and the proposition of mitigating measures
  • Are trained on the documentation and filing of study risks (e.g. ISF/TMF)

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 Quality management

ISO 31000 – see in particular section

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


  • CTU – Clinical Trials Unit
  • eCRF – electronic Case Report Form
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISF/TMF – Investigator Site File / Trial Master File
  • ISO – International Organization for Standardization
  • QMS – Quality Management System
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Basic ↦ Quality and Risk ↦ Risk-Based QMS Responsibilities ↦ Study Staff

Provides some background knowledge and basic definitions

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

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

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

Starts with ethics and regulatory approval

Ends after successful study initiation

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

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

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-Based QMS Responsibilities ↦ Study Staff

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