Create new subject
For site personnel to start entering the subject's data collected during in a clinical trial, you must create that subject in EDC.
Important
In EDC, the subject registration functionality is only available if the Managing Subjects value is set to In EDC in the ADMIN application.
If in the ADMIN application, Managing Subjects is set to In IWRS, you cannot register subjects via EDC and the New Subject icon is absent from the Subject List page.
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In the EDC application header, select the DATA ENTRY tab.
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On the site list page that opens, select the tile representing the site with which you want to work.
Figure 1. Accessing site
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Above the table, in the upper-right corner, select New Subject
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In the Register Subject dialog that opens, fill in the fields as explained in the following table.
Figure 2. Creating new subject
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
[Unique ID Label]
Enter the unique ID or edit the autogenerated one for the subject you intend to register.
The name of this field and the editability of the value depend on the unique ID configurations of your study in IWRS.Initial*
Enter the initials of the registered subject.
This field is only available if the respective setting is enabled via subject registration configurations of your study in IWRS.Registered Date*
Select the exact date and time of subject registration.
This field is only available if the respective setting is enabled via subject phase configurations of your study in IWRS.SAVE
Select
to implement your changes.CANCEL
Select
to discard the changes without saving. -
Select to save the implemented changes.
Once saved, a new subject is created. You can also export subject data from the EDC application to your local machine.
The action is recorded by the system, and the history of such actions can be reviewed via the Audit Trail functionality.