About Studio

Vault EDC contains a study design and management interface, EDC Studio, to enhance the experience of clinical programmers as they design their studies. Using Studio, clinical programmers can quickly create studies and manage study amendments for their organizations.

Studio Features

EDC Studio contains many features to ensure that clinical design is as seamless as possible.

Study Design

  • Drag & Drop: Studio includes a dynamic drag and drop environment that allows users to drag objects from a component palette and drop them onto a design canvas. Users can then rearrange and reorder objects by dragging and dropping objects on the design canvas.
  • Properties Panel: Clinical programmers can easily manage study object definitions using the Properties panel. With this tool, users can quickly define data types, date ranges, labeling, and more, without leaving the main Studio view.
  • Object Reuse: Clinical programmers can reuse study object definitions across multiple Studies. With this feature, users can also create libraries of object definitions and reuse them across multiple Studies in their vault.
  • Casebook Validation: Clinical programmers can use Vault EDC to validate their study design before publishing it. Vault EDC reviews the design and generates a CSV report of errors in the design that prevent creation of new Casebooks based off of this Casebook Definition.

Study Management

  • Multi-Organization & Multi-Study Support: Vault EDC Studio can support single sponsor or CRO study builds. Users can group Studies into Organizations, which can represent sponsors, business units, or other groupings within the study design environment.
  • Casebook Versioning: Vault EDC Studio supports multiple casebook versions, so that organizations can easily manage protocol amendments and other changes during a study.
  • Study Rule Validation: Vault EDC Studio supports study rule validation, including the automatic creation of univariate (system) checks and the ability to create additional checks as Rules with formulas.
  • Clinical Data Mapping: Vault EDC Studio supports the configuration of Views to map clinical data into an exportable CSV format.