SMART EDITOR
Introduction
The 4C Supply® SMART Editor is where users can specify scenarios for use in forecast calculations. Scenario specifications consist of multiple sections which belong to the following four main categories:
Patient journey
The patient journey describes events that are forecasted to occur once a patient has been enrolled in a study along with the corresponding probabilities. The visit schedule defines the study visits and their timing. The visit actions table describes the allocation of medication to patients at different visits. Randomization, titrations, and discontinuations describe decision points in the patient journey along with the corresponding probabilities.
Users can also model more sophisticated patient journey models such as:
Patient population over space and time
The patient population over space and time describes when and where patients are enrolled in the study. The Site Groups table describes the study sites, how these are forecasted to become active and (for simple models) how patients are forecasted to be recruited. For more sophisticated enrollment models, an enrollment table can be used to describe the patient accrual process.
Distribution network
The distribution network describes how materials are distributed from the release location(s) to the study sites. The Site Network table describes the regions where the sites are located and the depots supplying those regions. The Depot Network table describes the packaging locations and depots and the relations between them.
Product
The product describes the materials that are used in the study. The dispensing units table contains the core information about the different materials, such as the shelf life. In addition, users have the option to define existing and planned lots or production settings, which will be considered in the forecast calculation.