Accessing the Subject Manager, Registering/Adding New Subjects/Participants, or Withdrawing Subject Access
Subjects (also referred to in this knowledge base as "Participants" or "Patients") are registered from the Subject Manager screen, accessible from the main navigation menu or the top of the home screen.
Table of Contents:
Registering a new Subject
Depending on how the study has been configured, subject IDs are either automatically generated when a new registration form is saved, or manually entered prior to filling out the registration form.
In this example, the system displays an option to generate a new Subject ID, but some studies may do that automatically when a subject is added.
When adding a new subject, a form will open that needs to be completed. This form varies from study to study. Here we generically refer to it as the “Registration” form.
After completing the registration form (actual name of the form may vary), you can return to the previous page where the list of subjects is displayed for the current site. Tapping on any of the subject IDs will open the casebook for that subject.
Opening up a subject's casebook after the registration form has been saved is dependent on first completing the subject registration form without any errors on the form. Only then can a subject be opened up for further access.
Accessing an Existing Registration Form
To get back to the registration form for an existing subject, tap on the registration form icon on either the web or the mobile app, see below.
ePRO Studies - Registering Participants to Access Their Forms
If the study is registering Participant users to access their own forms for data entry (ePRO), the registration form will contain a field collecting the Participant’s email address.
The email address must be one that the Participant has access to receive emails. If not, they will not receive sign in information or notifications of forms as they become due.
Only enter email addresses for those Participants that have provided permission for correspondence from the TrialKit platform. Fictional or inactive email addresses that bounce will greatly degrade a study’s ability to deliver email notifications to all of its users.
When an email address is saved, checks are in place to verify the email address is not:
- Already another subject in the same study
- A non-participant/Clinician user in the TrialKit system
The email address entered may be blinded to other users in the study based on the study configuration.
Patient email FAQs
Does TrialKit need the Patients real email address since it might contain PHI?
- The TrialKit platform maintains compliance and high standards on global regulations for user identification and privacy. Entering an email address into a study will not put that email at any risk, but there are a few rules:
- The email address must belong to the Participant. It is not necessary to be identifying (e.g. could be an alias).
- If the email address does not belong to the Participant they will not receive any information or notifications from the system. If the Sponsor is comfortable with Participants not receiving notifications, the study Builder should be sure all notifications for the study are disabled so the system does not attempt to send the Participants an email. If an email is attempted, it will fail.
- The main rules are simply that the email must exist and be unique per subject if notifications are to be used.
Withdrawing or Exiting a Subject
Subjects (Participants) will lose access to forms when a study exit form has been submitted either by a Clinician or the Participant. The study exit form is some form that is defined by the Study Builder. It's location and availability can vary by study.
If an exit date has been submitted on the study exit form, TrialKit will prevent new data entry beyond that date for the corresponding Subject.