What is it? Why is it important?

At the site initiation visit (SIV) the study site is made ready for study start, enabling them to start recruiting study participants.

SIV is performed to ensure:

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For a SIV to take place the following criteria must be met:

  • EC approval received
  • If applicable RA or FOPH approval received
  • Database ready for data entry
  • IMP/MD & Material available at site
  • Staff trained on GCP

What do I need to do?

  • Agree with site on SIV date
  • Invite all relevant study personnel to the SIV
  • Prepare agenda and topics to be trained
  • Check TMF & ISF filing (pre-study documents)
  • Insure that IMP/MD is available at site
  • Provide database access (login) for data entry
  • Ensure approved (last) version(s) of study or quality documents are present

For more information refer to Monitoring and Documents in this Study Guide.

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As a Site-INV:

  • Prepare your site for an upcoming SIV
  • Ensure that all relevant staff members with study responsibilities are present at the SIV
  • Absentees will have to be trained at a later date which requires additional time and effort
  • Upon SIV completion sign the site visit report
  • Receive notification by SP-INV that the study can be initiated
  • Study start means that recruitment of study participants can be initiated

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissethics – see in particular

  • Templates for Patient information

KOFAM – see in particular

  • FOPH portal for human research

References

ICH GCP E6(R2) – see in particular guidelines

  • 4.5 Protocol compliance
  • 5.18 Monitoring activities

Swiss Law

HRA - search for “categorisation”

ClinO – see in particular articles

  • Art. 5 GCP
  • Art.19 Categorisation
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • GCP – Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product / Medicinal Device
  • ISF – Investigator Site File
  • RA – Regulatory Authorities
  • Site-INV – Site-Investigator
  • SIV – Site Initiation Visit
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Set-Up ↦ Quality and Risk ↦ Site Initiation Visit ↦ 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 ↦ Quality and Risk ↦ Site Initiation Visit ↦ Site Initiation Visit

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