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 QMS and risk management procedures, including the filing of study essential documents (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 (access liable to costs) – see in particular section

  • Risk management: Principles and guidelines


  • CTU – Clinical Trials Unit
  • 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 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-Based QMS Responsibilities ↦ Study Staff

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