What is it? Why is it important?

The site initiation visit (SIV) report documents all activities and topics covered during the SIV, such as:

  • Staff attendance
  • Provided trainings (e.g. eCRF completion, IMP/IMD handling related to access rights, storage conditions, documentation of inventory, and dispensing to participants)
  • Demonstration and training of laboratory procedures
  • Discussion and training related to study processes (e.g. safety reporting, IMP/IMD administration, study SOPs)
  • Possible unresolved issues, suggested measures to solve them, and a timeline for resolution
  • The location and retrieval of study SD

What do I need to do?

If you are the study monitor:

  • Write the SIV report, including the monitoring scope as defined in the MP
  • Outline outstanding unresolved issues and how to resolve them
  • Forward the report to the SP-INV and include any changes made by the SP-INV
  • Make sure both you and the SP-INV date and sign the approved report
  • File the original report in the TMF and send a copy to the monitored site to be filed in the ISF
  • Potentially write a follow-up letter / e-mail to the Site-INV of the study site, who files it in the ISF


If there are open issues, check back with the study site at some later date. If applicable, provide any additional support required to resolve open issues. Document and explain the resolution of open issues in a subsequent routine monitoring report

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

  • 5.18 Monitoring activities

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

  • Monitoring reports


  • CTU – Clinical Trials Unit
  • eCRF – electronic Case Report Form
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • ISF – Investigator Site File
  • ISO – International Organisation for Standardisation
  • MP – Monitoring Plan
  • SD – Source Data
  • Site-INV – Site-Investigator
  • SIV – Site Initiation Visit
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Set-Up ↦ Monitoring ↦ Site Initation Visit ↦ Report

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 ↦ Report

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