5.2 Build and Modify Study

Use the Build Study page to create or edit the Study Details, CRFs, Event Definitions, Subject Group Classes, Rules, Sites, and Users. Follow this basic workflow to design or edit a Study:

  1. The Study must exist, having been created using the Administration module.
  2. Change the current Study to the Study you want to work on. You must work at the Study level; the Build Study features are not available at the Site level.
  3. Access the Build Study page by selecting Tasks > Build Study.
    The Build Study page opens for the current Study, presenting a table of the main Tasks, with status information for each, and options to view details, create new elements, and edit the existing configuration.
  4. Set the Study Status, if needed:
    • When you are creating the Study, set the Status to Design, then click the Save Status button.
    • After you've created the Study and are making edits, set the Status to Available, then click the Save Status button.
      For more information, see Status of Study.

  5. Add to or edit the Study configuration by clicking the appropriate icon for Tasks 1 to 5 in the table. For details, see the following sections:
    1. Create Study: Edit Details
    2. Create and Modify Case Report Forms (CRFs)
    3. Create and Modify Event Definitions
    4. Create and Modify Subject Group Classes
    5. Create and Modify Rules

    When you begin to work on a Task, the Task's Status changes from Not Started to In Progress.

  6. When you have finished a Task, select the checkbox in the Mark Complete column, then click the Save button. The Task's Status changes from In Progress to Complete. Note that you can make changes to a Task, even when its Status is Complete.
  7. After Tasks 1 to 5 are marked complete, add or modify Sites.
  8. Add or modify Users.
  9. If you haven't already done so, set the Study Status to Available, and click the Save Status button.
  10. After the Status is Available, add Subjects to the Study and start collecting Study data.

Build Study Page After Completing Study Setup:

Build Study

Approved for publication by Benjamin Baumann (bbaumann), Principal. Signed on 2014-03-24 9:38AM

Not valid unless obtained from the OpenClinica document management system on the day of use.