It is possible to create a new subject from multiple places using Datacapt. It is also possible to create and user an Online account for a subject. Discover how to manage this aspect using Datacapt
1. Create a new subject
1.1 Manually from the Database
Staff with the required permissions can manually create a subject directly in the Subject Database.
Steps to Create a New Subject:
Navigate to “Subject Database”.
Select “+ Add Subject”.
Complete the subject’s personal information.
Select “Generate Platform ID” or enter an ID manually.
Select “Submit”.
Click on the newly generated row.
If necessary, select “Full Profile View” to access the subject’s details.
Complete the forms.
Notes:
After step 5, a new subject is created in the Subject Database.
Subjects created manually do not have an online account by default. To activate an account:
Open the subject’s profile.
Click the three dots to open the options menu.
Select “Account Creation”.
The subject will receive an email to create their online account.
1.2 Manually from an EDC Study
Staff with the required permissions can also manually create a subject directly within an EDC study.
Steps to Create a New Subject from an EDC Study:
Navigate to your EDC study.
Go to the “Subject” page.
Select “+”, then choose the tab “New Subject”.
Complete the subject’s personal information.
Select “Generate Platform ID” or enter an ID manually.
Select “Add”.
Note:
To access personal information, you must activate the appropriate option in your study settings.
For more details, refer to the guide on EDC Subject Management.
1.3 Online by the subject
Subjects can create their own online accounts using a public link or QR code. This can be shared via your website, email communications, or marketing materials.
Prerequisite:
Before subjects can register, you must 👉 configure the Subject Database and set up the questions they will answer during the first registration.
Steps to Get the Public Link:
Navigate to “Subject Database”.
Select “Settings”.
Open “Public Registration”.
Copy the QR code and/or public URL.
Share the link or QR code wherever needed.
Steps to Create a Subject Account Online:
As a subject, open the account registration page via the QR code or public URL.
Complete the personal information form.
Create a secure password.
Tick the opt-in boxes.
Select “Sign Up”.
Check your email inbox.
Confirm account creation via the link in the email.
Complete the subject registration survey as the first step.
Notes:
After step 5, a new subject is created with a status of “Pending”.
Notes :
After step 5, a new subject is created with a status of “Pending”.
1.4 General information
The email field acts as a unique identifier. Two subjects cannot be created with the same email address.
All subject contact information managed at the database level is automatically reflected on the “Subject” page of an EDC study. Any updates to these fields will be synchronized across all modules using this information.
In the current version of Datacapt, it is not possible to push or retrieve variables between an EDC study and the Subject Database.
A subject can be linked to a study by navigating to the “Subject” page in the EDC study and selecting “Subjects in the Database” under the “+ Add a Subject” option.
2. Update subject's information
This section explains how to update a subject's information, manage their online account, and restart their registration survey.
2.1 Update subject information
Only staff members with access to the Datacapt Subject Database and the correct permissions can view or modify subject details. However, subjects can independently update certain contact information online.
Information Subjects Can Update Online:
First Name and Last Name
Phone Number
Email Address
Language
Steps to Modify Personal Information Online as a Subject:
Open the lab’s public URL.
Log in to the personal online account.
Navigate to “My Profile”.
Under the relevant category, select “Edit”.
Update the information and select “Save”.
Steps to Modify Subject's Information Online as a Staff Member:
Navigate to the Subject Database module.
Search for the relevant subject.
Click on the subject’s row.
Notes :
All modifications and activities are logged under the subject’s detail page, visible in the “Activity” tab.
For security and administrative reasons, subjects cannot access or modify their personal details beyond the allowed fields in their online account.
2.2 Create a subject Online account
If a subject was manually created by center staff, it may be necessary to create an online account for them. If the subject’s personal information shows an account status of “No Account” or “Not Activated”, follow these steps:
Steps to Create a Subject Online Account:
Navigate to the Subject Database.
Search for the relevant subject row.
In the Quick View, open the menu using the three dots.
Select “Account Creation”.
The subject will receive an automatic email to finalize account creation.
Steps to Resend the Online Account Activation Link:
Navigate to the Subject Database.
Search for the relevant subject row.
In the Quick View, if the account status shows “Not Activated”, select the option “Resend Link”.
The subject will receive an email to finalize account creation.
Notes :
For bulk updates, select multiple rows from the subject database list and use the bulk action “Account Creation” located at the bottom of the screen.
2.3 Restart subject's Online Survey
If it is necessary to collect additional information or refresh existing details, you can resend the registration survey to your subjects.
Steps to restart registration survey:
Navigate to your subject database.
Filter on the subject(s) to update.
Select all visible rows.
Select the option “Restart Survey”.
Use the feature "campaign" to design and send an email asking them to connect.
Once connected, a new task showing the registration survey will be visible.
All previously completed questions will display the last existing answer, and all empty questions will need to be completed.
2.3 Add a subject’s picture profile
With DATACAPT , you can easily enhance your subject's profile by adding a picture, aiding your team in swift identification when subjects visit your center.
Here are two straightforward methods:
Upload a picture (from a computer): Navigate to the full profile, then click on the icon within the color circle. Select your desired picture, done!
Take a picture (from a tablet or smartphone): Similarly, in the full profile view, click on the icon within the color circle. Use your device's camera to capture a picture instantly.
To update the picture, simply delete the existing one and repeat the process.
Enjoy the streamlined process of enhancing your subject’s profile with visuals!
3. Delete subject details
Subjects’ personal information can be deleted upon request or for internal reasons.
Steps to Delete a Subject’s Personal Information:
Navigate to your Subject Database.
Open the subject’s profile in quick-view.
Click the three dots (action button) in the top-right corner.
Select “Delete”.
Enter the subject’s last name to confirm the deletion.
Steps to Bulk Delete Subjects’ Personal Information:
Navigate to your Subject Database.
Filter the subjects you wish to delete using the dashboard.
Select the rows to delete.
Use the bulk action “Delete”.
Confirm the deletion by entering the total number of rows to delete.
Note :
A subject not connected to any other object will be hard deleted.
A subject connected to at least one object will be soft deleted:
All personal information will be fully anonymized and replaced with “XXXX”.
The link to the object will be retained.