Obtaining consent from a study Participant
TrialKit has the capability of tracking consent for study subjects or registry participants. This article covers how Site staff can use TrialKit to consent participants.
Prerequisite: Study is configured for ePRO and consent
If a study is tracking participant consent, it will be shown directly in the subject list within the Subject Manager.
Tapping on a subject that is not consented will prevent opening the casebook. This is a visual on the Mobile App:
There are three ways for a participant to provide consent
- In-person on site
- Paper consent
If the participant’s email has been entered on the registration form, the participant will have direct access to TrialKit via the web or mobile app. They will be able to sign in and access their consent form. Once that's completed, their subject ID will show "Consented" as shown above.
Read more here about how Participants access and complete consent directly.
In-person on site
If a subject is on-site, tap the Handoff button in the upper right corner to enter handoff mode. Then select the desired subject in the resulting list.
The system allows for participants to bypass electronic consent and use an external process - typically paper consent.
If this function is allowed on the study, the participant’s registration form will contain a checkbox to indicate the use of paper consent.