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Subjects

Subjects are participants who are invited to the study. From the 'Subjects' page you can add new subjects to your study and manage the existing ones.

Profile

In the Profile section, it is possible to view and edit all information for subjects already invited to participate in the study.

1. Subject profile section displays Screening ID, Subject ID, user who created a subject (Created by), Site where the subject is added, preferred language of the subject and their status. Click on the pencil icon to edit the Subject ID, Site and Language.

2. Consent information (most recent) section allows to view the consent information. It displays data on the most recently sent consent form. Locking and unlocking ICFs can  be done by clicking on the 'Unlock' or 'Lock' buttons. Additionally, by clicking on the three dots menu, it is possible to View, Download, Sign in-person, Remove or Send a reminder for the most recent consent form

3. Screening information displays the eligibility status.

By clicking on the 'Update eligibility' status, it is possible to change the eligibility status of your subject. Select between 'Pass', 'Pending', and 'Fail' options in the dropdown menu and click 'Update status' to save the changes.

4. Personal details section allows to view and edit personal information of a subject.


Consent forms

The 'Consent forms' section allows to view and manage all consent forms which are sent to a subject, as well as to send new consent forms.

Consent forms: title of the consent form sent to a subject
Version: displays the version of the consent form and the version date
Consent status: status of the consent form
Sent on: timestamp when the form was sent
Consented on: timestamp when a subject consented
Form status: reflects whether a form is locked or unlocked. By clicking on the status, it is possible to either lock or unlock the form.
Options: by clicking on the three dot menu, it is possible to perform additional actions with the form, such as View, Sign, Download, Lock or Unlock.


Click on the 'Add new form' button to send a new consent form to a subject:

The 'Add consent form to subject' dialog window will open where you can choose to send the new consent form version and email notification.

Audit trail

The Audit trail tab displays time-stamped, sequential record of the history and details related to a particular subject.

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  1. Castor Support Team

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