This article provides a step-by-step guide to building your Subject Database in Datacapt.
1. Initial configuration (create)
With Datacapt, you can easily build your Subject Database to suit your study’s requirements.
1.1 Initiate your subject Database :
Log in with a user account that has the required permissions to build the database.
Access the Subject Database Module.
Select the option “Settings”.
Click on “Database Form Builder”.
Begin creating your structure.
2. Build forms and questions
Set up the structure for your questions. This structure will be reflected in the subject’s full profile, helping you organize data by categories.
2.1 Create Your Subject Database Structure
Set up the structure for your questions. This structure will be reflected in the subject’s full profile, helping you organize data by categories.
Steps to Create/Update Your Subject Database Structure:
Click on “Add New Section” and name it.
Within the new section, click on “Add Subsection” and name it.
Add as many sections and subsections as needed.
Click on “Save” to save your structure.
Tips:
Before building your database, create a document to outline your ideal database structure and questions. This preparation will save you time during the creation process.
Start with one form and test the results. Avoid building the entire database only to discover issues at the end. Apply an agile approach by building and testing incrementally.
2.2 Add Questions to Subsections
You can add questions to each subsection, which will appear in the subject’s profile and be available for filtering contacts.
Steps to Create New Questions:
Search for and open the subsection you want to update.
Click the “Add Question” button.
Select a question type (e.g., text, radio, checkbox, calculation, etc.).
Configure your question by completing the following fields:
Title
Description (optional)
Image (optional)
Variable: A short, comprehensive, and unique identifier.
Question Options (depending on the question type).
Configure question visibility using:
Show in Survey: If selected, the subject must answer this question during their first login to their online account.
Show in Quick View: If selected, users accessing the subject’s details will see the question in the quick view panel on the right before accessing the full profile view.
Save.
Question Types:
Text: Allows up to 2000 characters of free text.
Radio Buttons: Up to 50 options with labels and values.
Checkbox: Select one or several options.
Date/Time: Date and/or time-related questions.
Number: Allows entry of integer and decimal values.
Rating: A scale from 0 to 10.
File Upload: Allows uploading up to 5 files.
Dropdown: A list where one answer can be selected.
Slider: A question with a minimum and maximum value.
Calcul : Perform calculations based on other question results. Display other questions results. Display system variables.
Static Content:
Instruction: Display text instructions.
Header: Display a title.
Image: Display images with the ability to zoom in.
2.3 Add visibility conditions and data validation
Visibility conditions can be added at multiple levels to minimize visible questions based on previously collected answers (e.g., if “Female,” then show related questions).
Visibility Conditions Can Be Applied To:
Questions
Subsections (forms)
Sections
3. Test Database Forms
Regularly test your Subject Database during the design process to confirm it works as expected.
3.1 Test from the Center View
Check the final results as a user connected to the platform with access to Subject Database details.
Steps to Test from the Center View:
Navigate to the Subject Database View.
Select “+ Add Subject”.
Complete the subject’s information.
In the table view, click on the row representing the subject.
A right panel will open.
Observe the information visible under Quick View.
Use “Full Profile View →” to navigate further.
Check the forms, questions, and visibility conditions by completing the subject’s details.
Tips:
Keep one browser tab open on the Subject Database Builder and another on a test subject profile.
Make changes in the builder, then immediately test them in the test profile by reloading the page.
Apply an agile approach by building and testing simultaneously.
3.2 Test from the Online Subject View
Check the final result from the subject’s perspective by reviewing the first registration survey online.
Steps to Test from the Online Subject View:
Navigate to the Subject Database View.
Select “Settings”, then “Public Registration”.
Copy the center URL.
Open an incognito window.
Create and validate a subject account.
Open the registration survey.
Review the results and confirm everything displays as expected.
Tips:
Keep one browser tab open on the Subject Database Builder and another on a test subject’s online account.
Make changes in the builder, then immediately review and test them in the test account by reloading the page.
Apply an agile approach by building and testing simultaneously.
3. Configure users access to center(s) subjects
To enable users to access subject information and perform recruitment activities, two key configuration steps must be considered:
1. Configure Roles & Permission
Review and customize roles and permissions assigned to users to align with your organization's rules. This ensures proper access control within the module. 👉 Learn more about Roles & Permission.
2. Configure User-Center Access
The Datacapt Subject Database is designed to manage multiple centers within the same platform. To grant a user access to a specific center’s details, the following configuration must be completed for each user.
Prerequisite: At least one center must already be configured on the platform.
Steps to Allow a User Access to Center Subjects:
Navigate to Platform Settings.
Open the Users page.
Search for the user you want to configure.
Modify the user’s platform center access.
Select the center(s) the user is permitted to access and view subject information.
Key information :
This configuration primarily impacts the CTMS - Subject Database and Recruitment modules.
The option is visible only if the Subject Database Module is activated on the platform.
For EDC - Clinical center access, settings are configured at the study level, offering granular access control.