Before you can generate any EDC records, the participant has to exist inside the clinical study. This article covers creating one, and the setting you need to turn on first if you intend to contact them.
š Prerequisite: if you use ePRO or eConsent, the collection of the subject's communication details has to be enabled first. A new study is deliberately configured to collect as little personal information as possible, so this is off by default.
Enable personal details
š ļø Step by step guide
Navigate to Settings under your study.
Open the Options tab and select Edit.
Find Enable Subject Personal Information.
Select Activate First Name, Last Name and Activate Email, Phone Number, and Language.
Save.
š” Tip: only enable what the study actually needs. Every field you switch on is personal data you then have to hold and justify. For the fuller picture, see Configure participant personal information.
Create a participant
š ļø Step by step guide
Navigate to Subjects under your study.
Select + Subject.
On the New Subject tab, complete the first and last name, the email, the phone number if you want it, the subject's language, and their center.
Set the Platform ID manually, or let it be generated.
š” Tip: the New Subject tab is one of three routes. You can also pull somebody in from the Subject Database, or, if you run recruitment studies, from a linked recruitment study. See Include a subject and open their eCRF.