Stage 1: Study Design
Your study design includes all data collection and evaluation entities that exist in your Study. During the design phase, you will create your Event Groups, Events, Forms, Item Groups, Items, Codelists, and Units as “design definitions” in Studio. You will also create Rules to perform data validation, as well as allow for dynamic study design (adding and removing certain entities from a Casebook based on user-entered data). During the design phase, you can also choose to configure View Sets, for data transformation and export, Signature Definitions, and Review Plans.
Tasks in the study design phase are typically performed by Study Designers or Vault Owners.
If your vault has includes the Vault Coder application, you will also perform certain configuration and setup tasks for clinical coding during the design phase. These tasks are typically performed by a Vault Owner and a Coding Administrator.