What is it? Why is it important?

During the Site Initiation Visit (SIV) the site staff is trained on all relevant study aspects, enabling them to start the study.

Depending whether it is a mono- or multicentre study, the SIV can be performed as:

  • A personal visit to the site
  • A video conference
  • A telephone conference

The type of visit to choose depends on:

  • Study complexity and risk, as determined by the RBM score calculator
  • The distance between SP-INV location and study site, and thus expected cost

The SIV is documented in:

  • The SIV report
  • The monitoring visit log, which is signed by the monitor and a site staff member
  • The site staff attendance log

More

If practicable, a SIV can be planned as a joint meeting, where several different sites from the same study participate.

During SIV, there are several different issues that must be trained and discussed with the site staff:

  • The study protocol (e.g. design, eligibility criteria, endpoints)
  • An overview and location of study SD
  • Staff responsibilities (e.g. introduction of a site delegation log). Even though the Site-INV can delegate study tasks to qualified staff, the final responsibility always remains with the site-INV
  • Safety reporting procedures
  • IMP/MD handling (e.g. labelling, storage, access rights, inventory)
  • The introduction of special procedures (e.g. diagnostic tests, IMP/MD preparation and application, computer programs)
  • Processes that are solely performed at study site (e.g. IMP/MD handling, laboratory procedures, database access)
  • CRF entries (e.g. login, introduction of a study ID for participants)
  • Study documentation (e.g. management of study documents, TMF/ISF maintenance, training documentation)
  • Compliance with the study protocol, GCP, and applicable laws and regulations. Any substantial protocol amendment can only be implemented after initial EC and RA approval, as applicable
  • Communication lines with the SP-INV
  • The purpose of monitoring and the monitoring duties of the Site-INV (e.g. provide all necessary documents including medical record access to monitor during monitoring visits)

What do I need to do?

Ensure that the Site-INV and relevant study staff have adequate time at their disposal and are present during the SIV.

If you are the study monitor:

  • Follow activities as stated in the agenda and remain within timelines
  • Allow time for questions and answers
  • Ensure that attendees date and sign
    • The study delegation log
    • The SIV attendance log
  • Check and finalise TMF/ISF filing
  • Define procedures for potential outstanding issues, including timelines and follow-up

More

After the monitoring visit, the monitor:

  • Generates a list of all unresolved issues with suggestions on how to resolve them
  • Creates a timeline with deadlines for any outstanding issues
  • Is responsible to follow-up on any outstanding issues identified during SIV, in order to ensure site compliance
  • Discusses with the SP-INV whether to postpone participant recruitment due to major unresolved issues that might negatively affect patient safety or the quality of study data
    • Minor issues: The site can proceed with participant recruitment but must resolve issues within a defined timeline
    • Major issues: These must be resolved prior to participant recruitment (e.g. screening tools are missing, IMP/MD has not been delivered to the site, study labels are missing)

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

  • 4.5 Protocol compliance
  • 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

Swiss Law

ClinO – see in particular article

  • Art. 5 Good Clinical Practice
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • GCP – Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • RA – Regulatory Authorities
  • RBM - Risk Based Monitoring
  • SD – Source Data
  • Site-INV – Site-Investigator
  • SIV – Site Initiation Visit
  • SP-INV – Sponsor-Investigator
  • TMF/ISF - Trial Master File/Investigator Site File
Set-Up ↦ Monitoring ↦ Site Initation Visit ↦ Conduct
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 ↦ Conduct

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