Subjects are participants who are invited to the study. Selecting the ‘Subject’ sub-tab, a listing of all subjects (participants) that you have access to, based on your role and sites, will be listed. 

Subjects Overview

From the 'Subjects' page you can add new subjects to your study and manage the existing ones.   Only site admins can add subjects into the study. 

• Screening ID: field to specify the screening ID. 
• Subject ID: field to specify the subject ID.
• Invite Status: displays the status of the invitation. The following statuses are available - not invited, invited (an email invitation sent to a subject), active (subject accepted the invitation), rejected.
• Eligibility Status: field that display the participant's eligibility (Pending, Pass, Fail) for the study, can be enabled in the settings. 
• Consent Status: status of the consent form. The following statuses are available:
  • consented: all consent forms have been signed by a subject/LAR and/or study team members
  • awaiting consent: consent forms need to be signed by a subject/LAR
  • incomplete: a subject/LAR has signed consent forms and study team members still need to sign the forms
• Invited On: date and time when the invitation email was sent to a subject
• Consented On: date and time when the subject signed the consent form
• ICF version: the version of the informed consent form to which the subject has consented.
• Site: site where the subject has been recruited.

You can choose the ‘Filter’ option to further filter the subjects based on site, invitation date range, eligibility status, consent status, consent date range, counties, and archived records. As default archived subjects will not be shown in the subject overview. 

Profile

Double clicking on the Subject ID will open the Profile of a subject which displays Subject profile, Consent information, Personal details, and Video call depending on the study configurations:

Click on the 'Subjects' tab or the arrow icon to go back to an overview with all the subjects.

Consent forms

The 'Consent forms' tab displays consent forms for a specific subject:

In this tab, the following columns and options are available:

• Consent form: title of the consent form.
• Version: version of the form.
• Consent Method: electronic or paper method.
• Consent status: current status of the form.
• Sent on: date and time when the form has been sent.
• Consented on: date and time when a subject consented for electronic forms, for paper forms the date when a subject consented.
• Form status: the Locked icon will be displayed for locked forms . Click on the icon to unlock a form.
• Options: View, Download, Unlock/Lock, Send invitation, Sign-in person for electronic forms and Remove, Upload/Download singed form for paper forms.

Audit trail

The 'Audit trail' tab displays a log of changes for a specific subject:

Click on the audit trail entry log to access additional details related to each event: