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:


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
  • Delegated study tasks and responsibilities (e.g. documented 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

  • 5.0 Quality management

ISO 31000 – see in particular section

  • Risk management (access liable to costs)


  • 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
  • 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 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 ↦ Site-Investigator

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