The Study Setup module in OpenClinica provides flexibility and control so you can design and set up clinical trials with minimal effort.

To use the Study Setup module, the Study must exist. You create a new Study using the Administration module, providing basic information about it. Once the Study has been created, you provide more details about it using the Study Setup module.

The Study Setup module has the following features:

  • View Study: Presents the configuration of the current Study or Site, and an option to download the Study metadata.
  • Build Study: Provides options to Edit a Study, Create CRFs, Create Event Definitions, Create Subject Group Classes, Create Rules, Create Sites, and Assign Users. A table presents the status of these tasks so you can see what’s been completed and what tasks remain for the current Study.
  • Users: Shows all users and their Roles in the current Study or Site. Also allows you to assign users to the current Study or Site, and change or remove roles for users assigned to the current Study or Site.