Study Building Guide
This is a checklist to reference as you progress through a study build. The order listed below is not a requirement but is suggested for optimizing efficiency.
Helpful Hint: When you complete step 1, the system automatically performs the next 15 steps for you. But because every study is different, you will likely want to review each step below to customize your study per requirements.
Creating Study Workflow:
Customize the study theme (not required)
Basic study settings. Just the basics for now: functionality and audit settings. The remainder of the study settings will be set up later.
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!
Define which form is the subject "Registration" form. See Study workflow settings.
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.
Define any Unscheduled Visits
Refine the forms. This includes populating your forms with all needed fields and setting up your conditional actions.
Setup patient reporting and diaries (ePRO)
(if needed for the study)
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.
Auto-Validate your forms (not required)
Set up Randomization (if applicable)
Set up Inventory Management (if applicable)
Set up Medical Auto-Coding (if applicable)
Set up Lab Ranges (if applicable)
Set enrollment variable
Configure site documents and study documents (not required)
Define the study enrollment goals
Once the study is underway, changes may be needed: Making mid-study changes