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.
Pro Tip
Prior to any study build, it helps 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.
TrialKit AI can greatly assist in this process by generating a protocol or reading your existing protocol.
Be sure to understand how a study database is modeled.
Items listed below in Bold are required. Other steps listed are optional based on the study requirements. Click on the links to navigate to the corresponding details for each topic.
Create a new study within the Study Manager.
Customize the study theme.
Basic study settings. Functionality and audit settings.
Setup the forms. This includes all forms, regardless of how they will be used. It’s okay if the form is not completed. All that’s needed is a form with a title.
TIP!
Save days of work. Use TrialKit AI to build your forms.
Define the key study forms
Define Log Forms. From 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.
Set up scheduled visits - unless this was already done in step 4 with AI.
Define any Unscheduled Visits
Finish building the forms. This includes populating your forms with all needed fields and setting up conditional actions/edit checks.
Test the forms. As you build, quickly jump between a test subject and the form builder to view and test the forms.
Use AI to populate study data and validate the data entry
Verify the correct user Roles and permissions are set up.
Define the data review Workflow
Set up Randomization
Set up Inventory Management (IP tracking)
Set up Medical Auto-Coding
Set up Lab Ranges
Define the study enrollment goals
Once the study is underway, changes may be needed: Making mid-study changes
Creating Administrative/Validation Copies of Live Studies