Site Type Description – Study Site vs Facility (Shipping Site) in Mentor RTSM

This system recognizes two (2) different types of Sites, that are important to understand.

• A Facility (Shipping Site) is a site to which the drug ships for dispensing to subjects. Facilities exist outside of the context of individual studies, because of their possible use in multiple studies (pooling scenarios, etc.).
• For example, there may be an office at 19 N. Main Street, Sherborn MA that conducts various studies and is also known as Facility 1009.
• REMEMBER: If you do not want study supply to be pooled, you must create a unique facility for each study.
• CAUTION: It is important to identify the correct Investigator, Shipping Site, AND Depot prior to creating a new record for that entity. This action is particularly important for Depots, since a duplicate Depot record may have implications at the top of the supply chain.

• A Study Site is the location where Subjects are screened, enrolled, and followed throughout the course of a study. In the RTSM, every Study Site has a Facility configured to it for the purposes of shipping drug to the Site.
• For example: study ABC123 includes Facility 1009 and there is a corresponding Study Site with its own site code as defined by the protocol (which may match the shipping site code). This location Study Site may be listed as Study Site 1000.
• In addition to processing Subjects during the Study, Study Sites are configured with a defined location as well as associated with depots to receive study drug. Sites can also be grouped and used to set cap limits and custom configuration rules as defined by the study protocol.