TrialKit has the capability of tracking consent for study subjects or registry patients. This article covers how Site Clinicians can use TrialKit to consent patients.
Once a patient gets consented, depending on the study, they may receive an email with attached documents for their records.
For information on how patients themselves can remotely or virtually consent to a study, read here. Please note, this requires having entered the subject's email address on the registration form.
For information on setting up a study with this function, read here.
If a study is tracking subject consent, it will be shown directly in the subject listing within the Subject Manager:
If a subject is on site, tap the Handoff button in the upper right corner to enter handoff mode.
From the resulting list of subjects, select which subject you will be handing the device off to.
If the subject has not been consented yet, the consent form will automatically open. No other forms can be entered until the consent form is completed by the subject. If the subject has been consented already, there will be a listing of any ePRO forms which the subject currently needs to complete. They will also receive notices if their email has been entered on the registration form.