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Study Building Guide

A Checklist to Guide you Through Study Build

The list below serves as a reference for setting up a study. It is ordered in a way that will optimize efficiency but is not required to follow. Steps can be re-addressed over time in any order as needed.

It is very important, prior to any study build, to separately draft the flow of the study for a given subject. List out the forms that will be needed and which forms are repeating over time. This will save time during the form building process.

Here's an example template created in an external diagramming tool to represent a study design for a study Builder to reference.

Please read this guidance for additional recommendations.

Items in Bold are required. Other steps listed are optional based on the study requirements. Click on the underlined links to navigate to the corresponding details for each topic.

  1. Request a new study. Study copies can also be created within the Study Manager.
  2. Customize the study theme.
  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. Setup the forms
    This includes all forms, regardless of how they will be used. Don't worry just yet about building the forms out entirely. All you need is a form title with a single field. 
    Remember, there are different types of forms - subject, site, and study. At the very least Subject type forms will be needed.
  5. Define the key study forms
  6. Define Log Forms
    Of the forms built-in step 4, define which ones can be collected at any point in time. Common examples: Protocol Deviations, Concomitant Medications, and Adverse Events.
  7. Set up scheduled visits
  8. Define any Unscheduled Visits
  9. Finish building the forms. This includes populating your forms with all needed fields and setting up conditional actions/edit checks.
  10. Setup patient reporting and diaries (ePRO)
  11. 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.
  12. Auto-Validate the forms. Not required but highly recommended.
  13. Roles and permissions
  14. Workflow
  15. Query Settings
  16. Set up Randomization
  17. Set up Inventory Management
  18. Set up Medical Auto-Coding
  19. Set up Lab Ranges
  20. User Acceptance Testing (UAT). On the Administrative site, register a few test subjects and go through the study flow from beginning to end. This is the validation step of any good study build to assess how well the database will support both the protocol requirements and regulatory requirements. Read more here for suggested steps to follow.
  21. Define the study enrollment goals
  22. Add sites
  23. Add users
  24. Move the study live
  25. Once the study is underway, changes may be needed: Making mid-study changes
  26. Creating Administrative/Validation Copies of Live Studies