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/MD 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/MD 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

More

More

  • 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

References

ICH GCP E6(R2) – see in particular guideline

  • 5.18 Monitoring activities

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

  • 9.2.4.7 Monitoring reports
Abbreviations
  • CTU – Clinical Trials Unit
  • eCRF – electronic Case Report Form
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • ISF – Investigator Site File
  • 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
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

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
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

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
Completion

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

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