Consenting Participants
TrialKit has the capability of tracking consent for study subjects or registry participants. This article covers how Site Clinicians can use TrialKit to consent participants.
If a study is tracking participant consent, it will be shown directly in the subject listing within the Subject Manager:
There are three ways for a participant to provide consent
Direct/Virtual eConsent
If the participant’s email has been entered on the registration form, the participant will have direct access via the web or mobile app.
Read more here about how Participants access and complete consent directly.
Electronically On-Site
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. This will disable all other functions of the app for the subject to complete any action items due.
If the subject has not 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 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.
Paper Consent
The system allows for participants to bypass electronic consent and use an external process such as paper. If this function is allowed on the study, the participant’s registration form will contain a checkbox to indicate the use of paper consent. The site Coordinator must do this, after which the system will not enforce electronic consent directly by the participant.
Related articles