Found what I consider to be a good primer for those who wish to understand the process better.
“SITE INITIATION VISITS
A Pre-Selection Visit (PSV) is to ensure pre-qualification of a site and eliminate sites that do not possess adequate qualities to conduct the trial and must occur in order to determine if additional resources should be used to perform a Site Initiation Visit (SIV). Once the site has been selected and the trial has been awarded, a Clinical Research Associate (CRA) will be assigned to the site and a start-up packet will be sent along with any essential documents or items including but not limited to: lab kits, data collection equipment, relevant trainings, regulatory documents, and shipping items. As soon as the CRA has been selected for a site, it is their duty to introduce themselves to the lead staff [including Principal Investigator (PI)] and start to help the site with the completion of any action items. When the site is near the completion of all key elements the CRA is to communicate with someone from the site to schedule the best date and time that is accommodating for both parties but in favor of the PI. After a date has been determined, the CRA will send an SIV confirmation letter containing the details of all that will be expected of the site and performed or discussed on the day of visit. The primary objective of an SIV is to activate the site so that they can ultimately begin collecting data pertaining to the trial in the form of screening and randomizing study participants.
Before this can occur and the site can be activated, it is the responsibility of the CRA to verify that there are no pending submissions, approvals, documents, trainings or shipments essential to the success and start of the trial during the SIV. The CRA will typically be greeted by a Clinical Research Coordinator (CRC) and met by the PI shortly after. The CRA will typically be assigned to a monitoring room by the CRC to set up anything pertaining to the completion of the SIV. Most often, and even more so with newer sites or inexperienced staff members, there will be pending action items for the site to complete and it is important for the CRA to guide the site in the correct manner to achieve the completion of anything that needs to be done before that site can be activated. It is also helpful to remember that all CRA’s have different processes and preferences, the order of which is subject to change depending on what they feel is the most important to review first on a site-by-site basis.”
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