What is it? Why is it important?

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

  • The study MP is ready for implementation
  • EC approval has been received
  • If required, RA and/or FOPH approval has been received
  • The study database is ready for data entry
  • Study IMP/MD 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.

More

  • All studies must have EC approval
  • Swissmedic approval is required for
    • ClinO IMP studies with risk category B and C
    • ClinO MD studies with risk category C
  • 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?

Ensure that the following documents and tasks have been completed before the SIV takes place:

  • EC/RA 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

More

  • It is a great advantage, if prior to the SIV study staff has familiarised themselves with the study protocol
  • When submitting documents to the EC/RA, the Site-INV signs the final study protocol and thereby confirms that he or she has read and understood its contents, and agrees to comply with the protocol when conducting the study.

Where can I get help?

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

External Links

  • swissethics – Information on education and training

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
  • Art. 19 - 20 Study categorisation

HRO – see in particular article

  • Art. 7 Research categorisation
Abbreviations
  • 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
  • IMP – Investigational Medicinal Product
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • ISF – Investigator Site File
  • MD – Medical Device
  • 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
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 ↦ Prerequisite

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