What is it? Why is it important?

During the Site-Initiation-Visit (SIV), the monitor prepares the site for study start. Aim of the SIV is to ensure that:


The SIV is part of the monitoring strategy of the study.


In the event of unresolved issues that might negatively affect participant safety or the quality of study data, study start or participant recruitment should be postponed. Unresolved issues are categorizes as:

  • Minor issues: here the site can proceed with recruitment but must resolve issues within a defined timeline
  • Major issues: here the site must resolve the issue prior to participant recruitment

Major issues could be:

  • Screening tools and material are incomplete or missing
  • IMP/IMD has not yet been delivered to the study site
  • Staff has no access to eCRF
  • Applicable staff training is still outstanding

What do I need to do?

As a Site-INV, ensure all applicable site staff is present at the SIV. Main elements to review include:

  • The study protocol
  • Instruction on specific procedures (e.g. diagnostic tests, computer programs)
  • Study SD including its location (e.g. patient file, laboratory test results)
  • eCRF readiness and accessibility
  • Safety reporting procedures
  • IMP/IMD storage and handling, including applicable instruction manuals
  • Communication lines with SP-INV
  • Filing of essential documents in ISF/TMF
  • Documented staff trainings and delegated responsibilities (e.g. site delegation- and training-logs)
  • The training of study relevant SOPs, WIs, processes (e.g. ICF process)


It is the responsibility of the SP-INV together with the monitor to plan and conduct the SIV.


For more information refer to Monitoring in this Study Guide.

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 14155:2020 Medical devices (access liable to cost) - see in particular sections

  • 7.2 Investigator site initiation
  • CTU – Clinical Trials Unit
  • eCRF – electronic Case Report Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/MD - Investigational Medicinal Product / Medical Device
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • SD – Source Data
  • Site-INV – Site-Investigator
  • SIV – Site Initiation Visit
  • SOP – Standard Operating Procedures
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Set-Up ↦ Management ↦ Study Ready for Conduct ↦ Site Initiation Visit

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 ↦ Management ↦ Study Ready for Conduct ↦ Site Initiation Visit

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