What is it? Why is it important?

The Site-Investigator (Site-INV) is responsible to ensure the safety of study participant and the quality of study data at a particular study site.


During study conduct the Site-INV must:

  • Implement risk-based quality management procedures as defined by the SP-INV
  • Ensure that local quality requirements are in place (e.g. local SOPs, WIs, processes)
  • Ensure that site staff is qualified and trained on the conduct of the study, and trained on risk management, including additional quality aspects (e.g. Quality Assurance, Quality Control)
  • Inform the SP-INV regarding novel risk concerns, and propose local mitigating risk measures
  • Maintain ongoing study oversight


The Site-INV can delegate tasks and QMS responsibilities to study staff. Still, the ultimate responsibility remains with the Site-INV, who ensures the qualification and training of study staff.

What do I need to do?

As a Site-INV familiarise yourself and comply with:


During study conduct:

  • Supervise the efficacy of implemented risk control measures, as they might have to be adapted in order remain effective
  • Hold regular staff meetings, where study updates, issues, risk problems and solutions are discussed
  • Document important decisions and proposed solutions (e.g. meeting minutes)
  • Document delegated study tasks and responsibilities (e.g.  in a site delegation-log), and ensure staff is trained on QMS and risk management procedures

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

  • 1.34 Investigator
  • 4. Investigator
  • 5.0 Quality management

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

  • Risk management


  • CTU – Clinical Trials Unit
  • GCP – Good Clinical Practice
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • QMS – Quality Management System
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Basic ↦ Quality and Risk ↦ Risk-Based QMS Responsibilities ↦ Site-Investigator

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 ↦ Site-Investigator

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