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 Site-INV and study staff are trained on
    • The study protocol and the importance to comply with its specifications
    • GCP, SOPs/WIs, applicable legislations and relevant study procedures
    • Personal study responsibilities
    • Data entry (eCRF) including access rights
  • Study documents and necessary supplies for study conduct are available at the site
  • A contact list with responsible staff is available to all site staff.

More

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 defined timeline
  • Major issues: here the site must resolve the issue prior to recruitment

Major issues could be:

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

What do I need to do?

At the SIV, the Site-INV including applicable site staff should be present.

Main elements to review are:

  • The study protocol
  • Instruction on specific procedures (e.g. diagnostic tests, computer programs)
  • Study SD including location
  • eCRF readiness and accessibility
  • Safety reporting procedures
  • IMP/MD storage and handling
  • Communication lines with SP-INV
  • Filing of essential documents in ISF/TMF
  • Documented staff trainings and delegated responsibilities
  • Required SOPs including training

For more information refer to Monitoring in this Study Guide.

More

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

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 guidelines

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

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

  • 7.2 Investigator site initiation
Abbreviations
  • 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
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Set-Up ↦ Management ↦ Study Monitoring ↦ Site Initiation Visit
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 ↦ Management ↦ Study Monitoring ↦ Site Initiation Visit

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