A subject can be created in three different places, and can also be given a secure online account of their own. This article covers each route, how to keep a subject's information up to date afterwards, and what happens when you delete one.
Create a subject in the database
Staff with the right permissions can create a subject directly in the Subject Database.
🛠️ Step by step guide
Create the 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. The subject now exists in the database.
Click the new row, and select Full Profile View if you need the subject's details.
Complete the forms.
Give them an online account, if you want one
Open the subject's profile.
Click the three dots to open the options menu.
Select Account Creation. The subject receives an email inviting them to create their online account.
A subject created this way has no online account until you do the second half. That is deliberate: plenty of subjects are contacts you hold on paper and never invite online.
Create a subject from inside an EDC study
Staff with the right permissions can also create a subject from within an EDC study, without going to the database first.
🛠️ Step by step guide
Navigate to your EDC study.
Go to the Subjects page.
Select +, then the New subject tab.
Complete the subject's personal information.
Select Generate Platform ID, or enter an ID manually.
Select Add.
💡 Tip: to see personal information from inside the study, the corresponding option has to be turned on in your study settings. If the fields look empty from the EDC side, check that first. For the whole subject-in-a-study picture, see Include a subject and open their eCRF.
Let subjects register themselves online
Subjects can create their own account from a public link or QR code, which you can put on your website, in an email, or on printed material.
🔑 Prerequisite: the database and its registration questions have to be configured first. See Build your subject database.
There are two halves to this: you publish the link, then the subject completes the sign-up themselves.
🛠️ Step by step guide
Get the public link
Navigate to Subject Database.
Select Settings.
Open Public Registration.
Copy the QR code, the public URL, or both.
Share it wherever you need it.
What the subject does
Opens the registration page from the QR code or the URL.
Completes the personal information form.
Creates a secure password.
Ticks the opt-in boxes.
Selects Sign Up. The subject now exists, with the status Pending.
Checks their email inbox and confirms through the link.
Completes the registration survey as their first task.
How the database and EDC studies share information
Contact information held at database level appears automatically on the Subjects page of an EDC study, and an update to those fields is synchronized across every module using them.
You can link an existing subject to a study from the Subjects page of the EDC study, using Subjects in the Database under + Add a Subject.
In the current version of Datacapt you cannot push or retrieve variables between an EDC study and the Subject Database. Only the contact fields are shared.
⚠️ Warning: the email field is the unique identifier. Two subjects cannot exist with the same email address, so a shared family address or a placeholder used twice will block the second creation outright.
Update a subject's information
Only staff with access to the Subject Database and the right permissions can view or change a subject's details. Subjects can change four things themselves, from their own account: first and last name, phone number, email address and language. Everything else is yours.
🛠️ Step by step guide
As the subject, online
Open your center's public URL.
Log in to the personal online account.
Open My Profile.
Select Edit under the relevant category.
Update the information and select Save.
As a staff member
Open the Subject Database module and search for the subject.
Click the subject's row.
For contact information, select the edit icon beside it, update the details and select Save.
For anything else, go to Full Profile View, open the relevant form and update the answers.
💡 Tip: every change and every action is logged on the subject's detail page, under the Activity tab. That is where to look when somebody asks who changed a phone number and when.
Create or resend an online account
If a subject was created by staff, their account status reads No Account or Not Activated. Both are fixed from the same place.
🛠️ Step by step guide
Create the account
Navigate to the Subject Database and find the subject's row.
In the Quick View, open the menu using the three dots.
Select Account Creation. The subject receives an automatic email to finish it.
Resend the activation link
Navigate to the Subject Database and find the subject's row.
In the Quick View, if the account status reads Not Activated, select Resend Link.
💡 Tip: to invite many subjects at once, select several rows in the list and use the Account Creation bulk action at the bottom of the screen.
Restart the registration survey
Resend the registration survey when you need extra information, or when existing details have gone stale.
🛠️ Step by step guide
Navigate to your Subject Database.
Filter down to the subjects you want to update.
Select all visible rows.
Select Restart Survey.
Use Campaign to write and send an email asking them to log in.
Once they log in, a new task showing the registration survey appears for them.
Questions they answered before come back pre-filled with their last answer, so a subject only has to deal with what is new or empty.
Add a profile picture
A picture on the profile helps your team recognize a subject when they arrive at the center. Both routes start in the full profile view, on the icon inside the colored circle.
🛠️ Step by step guide
Open the subject's full profile.
Click the icon inside the colored circle.
On a computer, choose a picture from your files. On a tablet or smartphone, use the camera to take one.
To change a picture later, delete the existing one and repeat.
Delete a subject's personal information
You can delete a subject's personal information at their request or for your own reasons, one at a time or in bulk.
🛠️ Step by step guide
One subject
Navigate to your Subject Database.
Open the subject's profile in quick-view.
Click the three dots in the top-right corner.
Select Delete.
Type the subject's last name to confirm.
Several at once
Navigate to your Subject Database.
Filter down to the subjects you want to delete.
Select the rows.
Use the Delete bulk action.
Type the total number of rows to confirm.
⚠️ Warning: deleting does two different things, and which one you get is not your choice.
A subject connected to nothing else is hard deleted. They are gone.
A subject connected to at least one object is soft deleted: every piece of personal information is anonymized and replaced with XXXX, and the link to the object is kept.
Neither can be undone, and the confirmation step is the last point at which you can stop.