What is it? Why is it important?

The Site Initiation Visit (SIV) is conducted to prepare and set up the study site for study conduct. It takes place after EC/RA approval and prior to participant recruitment.

The SIV ensures that the site is ready to enrol participants by making sure that study:

  • Processes are in place (e.g. procedures for participant recruitment, data entry, safety reporting), IMP/MD handling, laboratory work)
  • Staff is trained (e.g. on the study protocol, study relevant SOPs and WIs, study processes, delegated responsibilities, handling of IMP/MD, location of SD)

What do I need to do?

The Site-INV and relevant site staff should be present at the SIV.

Main topics to review during the SIV are:

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

More

The SP-INV together with the monitor is responsible 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
  • 8.1 - 4 Filing of essential documents

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

  • 9.2.4.4 Initiation of the investigation site
  • Annex E: Essential clinical investigation documents
Abbreviations
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • ISF – Investigator Site File
  • SD – Source Data
  • Site-INV – Site Investigator
  • SIV – Site Initiation Visit
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
  • WI – Working Instruction
Set-Up ↦ Monitoring ↦ Site Initation Visit ↦ Aim
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 ↦ Aim

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