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  1. Define a new study

  2. Customize the study theme (not required)

  3. Basic study settings. Just the basics for now: functionality and audit settings. The remainder of the study settings will be set up later.

  4. Build the forms

    1. This includes all forms, regardless of where in the study they will be used. Don't worry just yet about building all your edit checks and getting every field perfect. All you need is a form title and a date field to start!

  5. Define which form is the subject "Registration" form. See Study workflow settings.

  6. Define Log Forms

  7. Of the forms built-in step 4, define which ones can be collected at any point in time. Common examples: Protocol Deviations, Concomitant Medications, Adverse Events.

  8. Set up scheduled visits

  9. Define any Unscheduled Visits

  10. Refine the forms. This includes populating your forms with all needed fields and setting up your conditional actions.

  11. Setup patient reporting and diaries (ePRO)

     (if needed for the study)

  12. Test the forms. As you make changes to your forms and edit checks, navigate to the Subject Manager to test them out. Also, use the mobile app to test out your forms on smaller screens.

  13. Auto-Validate your forms (not required)

  14. Roles and permissions

  15. Workflow

  16. Query Settings

  17. Set up Randomization (if applicable)

  18. Set up Inventory Management (if applicable)

  19. Set up Medical Auto-Coding (if applicable)

  20. Set up Lab Ranges (if applicable)

  21. Test your study

  22. Set enrollment variable

  23. Configure site documents and  study documents (not required)

  24. Define the study enrollment goals

  25. Add sites

  26. Add users

  27. Assign users to roles and sites

  28. Move the study live

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