Before a subject can join a study, they need to exist somewhere: either created directly in your Subject Database, or self-registered online. This article walks through both routes, then how that same subject moves into an eCRF, eConsent or ePRO study.
š Prerequisite: Subject Database access to register a subject manually. To carry that subject into a study afterward, you also need eCRF Record List (Access, Add) on the study.
Which one do you need?
You want to | Use |
Create the record yourself, from a list of names you already have | Add subject, in the Subject Database |
Let the person sign themselves up, from a link or QR code | Public Registration |
Add someone while you are already working inside an EDC study | New subject, or From database, on the study's Subjects page |
Register a subject in the Subject Database
Staff with the right permissions can create a subject directly in the Subject Database, one at a time or from a file.
š ļø Step by step guide
Navigate to Subject Database.
Select + Add subject, then Add manually.
Complete the fields you have: first name, last name, email, phone and language are all optional.
Choose the Center name. It is required.
Select Generate Platform ID, or type one in yourself. This is also required.
Select Submit.
Let a subject register themselves
Subjects can also create their own record from a public link or QR code that you publish. The full walkthrough, including what the subject sees on their side, is in Subject Information & Accounts.
š” Tip: the link and QR code live under Subject Database > Settings > Public Registration, and there is one per center. Grab the one for the right center before sharing it.
Enroll the subject in a study
A subject in the Subject Database is not yet in any study. To enroll them, open the EDC study and add them from its Subjects page, using the From database tab to search your Subject Database instead of retyping their details. The full procedure, including how recruitment studies feed into this step, is in Include a subject and open their eCRF.
ā ļø Warning: only the contact fields are shared between the Subject Database and an EDC study. You cannot push or retrieve other variables between the two, and the email field is the unique identifier: two subjects cannot share one email address.
Check on a subject afterward
Click any row in the Subject Database for a quick view of their contact info and which studies they belong to, or select Full profile view for the complete record, including every form answer.
š” Tip: in the current interface, the action to send a subject their account invitation is labeled Invite, in the three-dot menu of the quick view panel, alongside Restart survey and Delete. If you are following an older guide that says Account Creation, this is the same action under its new name.