The study configuration involves designing the eCRFs and configuration of edit checks to the respective data items in the eCRFs. The design and edit checks configuration is done using Study Builder which is available in EasyCDM Suite.

Process Description:

  • The Study builder will configure a study.
  • The study is categorized into a number of visits. A visit is a set of pages and a page is a set of panels. A panel is a reusable component and can be defined as a collection of data items. The edit checks are configured against each data item based on the requirement. All the unique panels in the study are identified and required Codelists are created.
  • Upon completion of the entire study configuration, eCRF designer conducts a first level UAT after which the study enters the testing phase.