---
title: "Study Building Guide"
slug: "study-building-guide"
updated: 2026-07-12T13:13:46Z
published: 2026-07-12T13:13:46Z
canonical: "help.trialkit.com/study-building-guide"
---

> ## Documentation Index
> Fetch the complete documentation index at: https://help.trialkit.com/llms.txt
> Use this file to discover all available pages before exploring further.

# 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.

> [!NOTE]
> 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](/v1/docs/study-database-design-and-modeling).

**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.

1. Create a new study within the [Study Manager](/v1/docs/study-manager#accessing-the-study-manager).
2. Customize the [study theme](/v1/docs/themeappearance-customization-overview#host-theme-vs-study-theme-on-the-web).
3. Basic study settings. [Functionality and audit settings](/v1/docs/study-functionality-settings).
4. [**Setup the forms**](/v1/docs/form-building). 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]
> TIP!
> 
> Save days of work. Use [TrialKit AI to build your forms](/v1/docs/ai-study-building).
5. Define the [**key study forms**](/v1/docs/study-functionality-settings#workflow-and-key-forms)
6. [**Define Log Forms**](/v1/docs/form-properties#log-form). 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.
7. [**Set up scheduled visits**](/v1/docs/scheduled-visits-and-cohorts) - unless this was already done in step 4 with AI.
8. Define any [Unscheduled Visits](/v1/docs/configuring-unscheduled-visits)
9. **Finish** [**building the forms**](/v1/docs/form-building-and-related-tools)**.** This includes populating your forms with all needed fields and setting up conditional actions/edit checks.
10. Setup [Participant date entry diaries (ePRO)](/v1/docs/configuring-study-for-epro-and-ediaries)
11. **Test the forms.** As you build, [quickly jump](/v1/docs/form-building-and-related-tools#previewing-a-form) between a test subject and the form builder to view and test the forms.
12. Use [AI to populate study data](/v1/docs/ai-data-generation) and validate the data entry
13. Verify the correct user Roles and permissions are set up.
14. Define the [data review Workflow](/v1/docs/study-workflow)
15. Set up [Randomization](/v1/docs/randomization-configuration)
16. Set up [Inventory Management](/v1/docs/inventory-configuration) (IP tracking)
17. Set up Medical Auto-Coding
18. Set up Lab Ranges
19. [User Acceptance Testing (UAT)](/v1/docs/study-validation-and-training)
20. Define the [study enrollment goals](/v1/docs/study-functionality-settings#6-metrics)
21. [Add sites](/v1/docs/site-management)
22. [Add users](/v1/docs/user-management)
23. [Move the study live](/v1/docs/study-functionality-settings#1-study-status)
24. Once the study is underway, changes may be needed: [Making mid-study changes](/v1/docs/version-management)
25. Creating Administrative/Validation Copies of Live Studies