What is it? Why is it important?

The study is ready to be initiated after the following criteria are met:

  • The study IMP is ready for implementation
  • EC approval has been received
  • If required, RA (e.g. Swissmedic and/or FOPH) approval has been received
  • The study database (eCRF) is ready for data entry
  • Study IMP/IMD and materials are available at the site or ready for delivery
  • The Site-INV is trained in GCP, including additional study staff as required.


The SP-INV confers with the study site to decide when the study site is ready to be initiated.


The SP-INV is responsible to appoint a monitor who is trained, has the appropriate scientific knowledge, and is thoroughly familiar with the study protocol and relevant study interventions

What do I need to do?

As a monitor ensure that the following documents and tasks have been completed before the SIV takes place:

  • EC/RA (e.g. Swissmedic) approvals, including relevant correspondence between SP-INV and Site-INV, are filed in the TMF and ISF
  • The testing phase of the study database (validation & approval) is complete, and ready for productive phase with data entry
  • IMP/MD and material has been ordered and is ready to be delivered to the study site
  • IMP has been labelled with approved study stickers
  • Study staff is qualified and trained in GCP


It is a great advantage, if prior to the SIV study staff has familiarised themselves with the study protocol

Where can I get help?

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

External Links


ICH GCP E6(R2) – see in particular guidelines

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

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

  • Initiation of the investigation site
  • Annex E: Essential clinical investigation documents

Swiss Law

ClinO – see in particular article

  • Art. 5 Good Clinical Practice
  • Art. 19 - 20 Study categorisation
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FOPH – Federal Office of Public Health
  • GCP – Good Clinical Practice
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • ISF – Investigator Site File
  • ISO – International Organisation for Standardisation
  • MP – Monitoring Plan
  • RA – Regulatory Authorities
  • Site-INV – Site-Investigator
  • SIV – Site Initiation Visit
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Set-Up ↦ Monitoring ↦ Site Initation Visit ↦ Prerequisite

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Set-Up ↦ Monitoring ↦ Site Initation Visit ↦ Prerequisite

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