What is it? Why is it important?

The Site Initiation Visit (SIV) should be well prepared because it provides an important opportunity to train staff on study tasks and responsibilities.

In most cases, the SIV is performed by the monitor(s) who presents the planned monitoring procedures; while the SP-INV presents the study protocol.

The SP-INV can appoint other personnel to perform the SIV. However, the SP-INV must ensure that those performing the SIV are well-qualified and properly trained to perform this task.

What do I need to do?

Ensure that the monitor performs his or her tasks according to the monitoring plan.

If you are the study monitor, prepare the site for an upcoming SIV:

  • Arrange a date for the SIV visit with the site and invite relevant staff
  • Prepare an agenda with topics to discuss, including what processes and tasks to train
  • Complete pre-study TMF and ISF filing. The ISF is handed over to the site at the SIV
  • Ensure that IMP/MD is available at the study site and ready to use
  • Confirm access to the study database needed for staff training
  • Decide on who will be responsible for any staff training
  • Prepare relevant study logs, such as the delegation log and a SIV training log
  • Prepare a SD location list. In a multicentre study prepare an applicable list for each participating site

More

Prepare an easy-to-follow and relevant study presentation:

  • Include diagrams or flow-charts. A clever designed image can replace highly complicated written procedures (e.g. the study design, SAE reporting, analytical processes)
  • A physician / Site-INV can present and explain more complicated medical issues
  • Make sure that the infrastructure needed for your presentation and training sessions is available at the site (e.g. a beamer, flip chart, video transmission, magnet board, material needed illustrate points)

In order to guarantee effective communication and training, use a local or common language. If needed, organise an interpreter who can participate at the SIV.

Where can I get help?

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

External Links

  • swissethics – Information on safety reporting
  • swissmedic – Information on safety reporting

References

ICH GCP E6(R2) – see in particular guidelines

  • 4.11 Safety reporting
  • 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
  • 10.8 Safety Reporting
  • Annex E: Essential clinical investigation documents

Swiss Law

ClinO – see in particular article

  • Art. 37 – 43 Safety Reporting

HRO – see in particular article

  • Art. 20 – 20 Safety notification
Abbreviations
  • CTU – Clinical Trials Unit
  • GCP – Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • ISF – Investigator Site File
  • SAE – Serious Adverse Event
  • SD – Source Data
  • SIV – Site Initiation Visit
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Set-Up ↦ Monitoring ↦ Site Initation Visit ↦ Preparation
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 ↦ Preparation

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