site initiation visit report template

Provide name and contact information of site personnel responsible for regulatory affairs. Review the contents of the site regualtory binders to ensure site has all required regulatory documentation to initiate the site.

This template provides a recommended structure for a CREST site visit report, as well as a sample matrix of regulatory criteria that CREST monitors look at while at site initiation visits (SIVs), interim monitoring visits (IMVs) and close out visits (COVs).

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It is important to read the Pre-Study Visit and Site Initiation Visit (SIV) reports, as well as the last one-two Interim Monitoring Visit (IMV) Reports (to clarify: the site’s location, site staff roles and responsibilities, the contact person at the site, the number of previous IMVs, the typical problems identified at the site, and the ...

A Site Initiation Visit (SIV) or Study Start-Up is an organized meeting to discuss the new protocol before the research project is ready to screen and enroll potential patients. It also serves as training for the protocol of interest.

Document the visit by signing the Site Visit Log. Ensure the initiation visit discussion and status of required items is documented on the Initiation Visit Checklist. Ensure the Initiation Visit Checklist is filed in the appropriate section of the Investigator’s Regulatory Master File.

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).

This document provides a template for a Site Initiation Visit (SIV) report. It includes sections for study and visit details, the site team, regulatory aspects, participant informed consent and enrollment, case report form and source data verification, and safety aspects.

An SIV (clinical trial site initiation visit) is a preliminary inspection of the trial site by the sponsor before the enrollment and screening process begins at that site. It is generally conducted by a monitor or clinical research associate (CRA), who reviews all aspects of the trial with the site staff, including going through protocol ...

Sample site initiation visit agenda template - PDF. Definition Site initiation is the final step in the study set-up process. Site initiation occurs prior to site activation. Typically, the sponsor or clinical research organization will conduct a ...