Clinical Trial Basics: Site Initiation Visit (SIV)

What is an SIV in clinical research?

SIV Definition: Site initiation visit

An SIV (clinical trial site initiation visit) is a preliminary inspection between the sponsor and the trial site before the enrollment and screening process begins. It is conducted by a monitor or clinical research associate (CRA), who reviews all aspects of the trial, from protocol to staff training. [¹][²]

Also known as a study start-up visit, the sponsor can only request an SIV after the site has been selected and agreements such as the CTA and CDA have been signed.

What is the purpose of an SIV?

Clinical trial SIVs are necessary to ensure that all personnel involved in the clinical trial, such as investigators and study staff, thoroughly understand the trial protocol and are trained to handle their role and responsibilities.

Furthermore, a site initiation visit ensures the trial site is operational-ready with working infrastructure, tools, and materials which helps streamline future efforts such as recruitment. [¹]

Given the scope of the SIV, clinical trial sponsors should schedule this visit well before enrollment so that there is plenty of time to comprehensively inspect all relevant processes.

Can the SIV be conducted before IRB approval?

IRB approval is necessary before an SIV. Clinical trial sponsors need to be sure they have selected a site that has fulfilled all the necessary regulatory requirements and is operating in compliance with IRB guidelines.

SIV checklist for thorough site initiation visits

Given the importance of an SIV, clinical trial sponsors and CROs need to make the most of this inspection visit by coming fully prepared with a detailed checklist that outlines the SIV.

Clinical trial sites should also have a copy of this checklist to ensure all relevant staff is present. Specific tasks to include in the SIV checklist include the following tasks: [¹] [²][³][⁴]

• Discussing clinical trial objectives with study staff
• Educating the research team on Good Clinical Practices
• Reviewing the operation schedule for the protocol
• Discussing the enrollment and screening process, including clarifying inclusion and exclusion criteria
• Reviewing the informed consent protocol
• Clarifying the procedure of storing and dispensing the investigational drug
• Checking inventory for all medical supplies and equipment
• Ensuring access to all digital platforms, i.e., correct usernames and passwords
• Touring the clinical trial site
• Reviewing and discussing all clinical trials documentation, such as forms, surveys, and manuals
• Reviewing the data management system
• Ensuring clinical trial staff understand how to maintain essential documentation
• Reviewing the financial protocols, including any processes related to compensating trial participants
• Checking reporting systems for possible adverse events
• Discussing specific concerns trial staff may have

This checklist provides the basic guidelines that can be used to build upon to create a complete agenda for an SIV. Clinical trial sponsors can add to these as required per their clinical trial design.