In order for a sponsor to find the number of research sites they need for a given protocol, they must engage sites that have confirmed both their capabilities and the availability of the patient population to conduct the study.
Most importantly it is imperative for sites with which they have no previous experience. Unfortunately, there is no way to collect information about potential sites other than to initially rely on the site's own, self-reported metrics and information.
This necessitates that the sponsor inevitably perform the pre-study visit (PSV). If there is some previous experience with the site, then this visit may be replaced with a pre-study phone call. This is not the Site Initiation visit.
Academy of Medical-Surgical Nurses (AMSN) and Medical Surgical Nursing Certification Board (MSNCB)
"Pre-study visits are critical to ensure the right sites are selected for the study. Site selection criteria include patient availability, PI and study team experience and availability, and adequate site facilities. By selecting qualified sites, sponsors and/or CROs are looking to ensure studies are conducted ethically, safely and that study integrity is maintained, the hallmarks of Good Clinical Practice (GCP)."
Objectives of the PSV
- Validate site claims made on SFQ and in previous discussions during site identification
- Evaluate condition of site
- Understand the full capabilities of the physical location and the abilities of the site staff
- Review patient recruitment strategies
- Meet PI to confirm or gain comfort regarding their ability and interest for the protocol
The PSV is typically viewed as a necessary evil by the site. This is mostly due to the inconvenience in hosting a study monitor for what is often a full day, but can be longer. This translates to a real expense to the site in terms of resources required to adequately prepare for and conduct the PSV; resources which typically are not reimbursed. It is considered a cost of doing business. However, the PSV also is an excellent opportunity for a site to make a good impression and get off on the right foot with their sponsor.
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