What is it? Why is it important?

The Site Initiation Visit (SIV) is conducted to prepare and set up the study site for study conduct. It takes place after EC/RA (e.g. Swissmedic) approval and prior to participant recruitment.


The SIV ensures that the site is ready to enrol participants by making sure that study:

What do I need to do?

As a monitor conduct the SIV. Ensure both the study Site-INV and relevant site staff are present at the SIV.


Main topics to review during the SIV are:


The SP-INV together with the monitor is responsible to plan and conduct the SIV.

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

  • 5.18 Monitoring activities
  • 8. Essential documents for the conduct of a clinical trial

ISO 14155 Medical Device – see in particular section (access liable to costs)

  • Initiation of the investigation site
  • Annex E: Essential clinical investigation documents
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • ISF – Investigator Site File
  • ISO – International Organisation for Standardisation
  • SD – Source Data
  • Site-INV – Site Investigator
  • SIV – Site Initiation Visit
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
  • WI – Working Instruction
Set-Up ↦ Monitoring ↦ Site Initation Visit ↦ Aim

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): Set-Up ↦ Monitoring ↦ Site Initation Visit ↦ Aim

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