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, and if applicable, access a partially signed consent form to apply additional signatures.
Table of Contents:
Prerequisite: Study is configured for ePRO and consent by an Administrator
If a study is tracking participant consent, it will be shown directly in the subject list within the Subject Manager by a consented/not-consented indicator next to each subject.
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, select the desired subject in the resulting list, and handoff to the subject.
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.
Adding Investigator or Other Clinician Signatures
Often times the consent form needs to collect more signatures than only the Participant's. In these cases, the signatures on the form will be assigned to the necessary user roles. For example, the site Investigator may be required to sign after the Participant signs.
Consent forms are accessible within the subject casebooks under the log forms - but only if the subject is fully consented (i.e. all signatures are collected). If signatures are missing on consent, the subject casebook is not accessible. Because of that, the consent form can be accessed a different way.
On the web browser, tap on the subject ID. If the subject is not consented, a window will appear listing all existing consent records. It's assumed that the Participant has already done their part and the form is now awaiting a countersignature.
On the mobile app, tap and hold for 1 second on a subject ID. This is a shortcut to open the full list of existing records for the subject. Tap the applicable consent record to open the form and sign it.
Required Signatures by Role Report
The Signatures report is a list of all forms and expected/applied signatures on any signature fields that have been assigned to a user role by a study Builder.
Prerequisite: User role has access to Signature by Role Management
This report is helpful as a single place to see where signatures are missing, or to apply signatures in batch to multiple forms.
For example, as a Site Investigator, the report could be opened at any time to catch up on the subjects awaiting signatures on their consent forms in order to be fully consented in the study.
To access it, currently only via the mobile app, open the Reports menu: