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Monitoring Site Initiation Visit (SIV) Report Template

Carefully assessing whether a site is ready to start a trial is a crucial step towards mitigating risks when conducting a trial. This template includes a step-by-step checklist for monitors and covers all the important aspects of a site initiation visit (SIV). It complements our series of monitoring templates covering all aspects of monitoring from the starting line to the finish line. These templates are freely accessible and are suitable for all sites doing clinical research.

Is your site ready to start a trial?

What it is:

The up-to-date and user-friendly Monitoring Site Initiation Visit (SIV) Report Template can be used to report a site initiation visit.

What it can do:

This template is a step-by-step checklist with convenient drop-down lists. It guides monitors through all the important aspects of a site initiation visit (SIV), so they can assess whether a site is ready to start a clinical trial. It is part of a series of monitoring templates that includes:

Who should use it:

This template is suitable for any monitor engaged in clinical research in Switzerland and abroad. We particularly recommend using this template within the SCTO’s CTU Network for investigator-initiated, multicentre studies. It can also be used as a self-assessment form for study sites in anticipation of a site initiation visit.

Who is behind this resource:

This template was developed by the SCTO’s Monitoring Platform and first published in August 2021 and last revised in March 2023 (V3).

Preview

Monitoring Site Initiation Visit Report, cover page

Monitoring Site INitiation Visit Report, page 1

Monitoring Site Initiation Visit Report, page 2

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Download

This template is licensed under CC BY-NC 4.0. Its content can be shared and adapted as long as you follow the terms of the license. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc/4.0/.

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Our templates and tools are free. As a publicly funded organisation, we strive to inform the public about the impact of our work and to continually improve our services. We therefore kindly ask you to leave us your email address so we can contact you with a short one-time survey. You may download the document without providing your personal data.