Setting Up Patient Consent

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The system has eConsent rules built in to make informed consent a streamlined part of study data collection. Rather than trying to manage it through a separate process, TrialKit can electronically enforce the completion of a consent form and provide the patient access to site-specific consent documents.

The following is possible with the e-consent capabilities:

• Subjects/patients can fill out their own consent forms and receive an automatic email verification of that consent along with copies of the documents that were signed

• Subjects can view site-specific consent documents.

• Consent can even be used to control further data entry of forms being deployed to the Participant (read more about ePRO)

• Patients can revoke consent with reason, or Administrators can require re-consent on batches of subjects

• Subjects, consent status, and consent history can be tracked

Table of Contents

Configuring Consent

The eConsent function will only work if the study is an ePRO study where the subject email is getting registered on the registration form. Read more about configuring ePRO here.

Like most functions, the first step is to ensure your role has the appropriate role permissions to configure the consent rules. This is done in role security under the Informed Consent application.

Once enabled, there will be an option under the study configuration menu to Configure Informed Consent:

Reference the annotated image below on the various functions defined on the screen:

1. Enable the consent tracking function and define which form the patient will be filling out as the consent form. Only ePRO log forms, as defined in the form's properties in the form builder, can be selected.

2. Opt to send the patient an automated email once they complete the consent form, and set which distribution email will go out. Emails can be scripted within the form builder on the web.

3. If there are non-specific, or general, documents that go to all subjects regardless of their site, the full list of documents can be used to choose from. This is not a common selection made.

4. A site document file for informed consent is the most common option to include as email attachments to the patient. This section is a list of upload fields from the site document forms in the study. Any document uploaded to that field will go out to the patient after they provide consent.

5. Optional step: This is a list of all site document file fields similar to #4. However, this is where you can identify which document should be displayed on the consent form for the subject/patient to view. 

6. Include any cc email addresses which should be on the recipient list when consent verification is sent to the patient after they consent.

Dual-Signature Consent

Dual-Signature consent refers to two separate parties being required to sign before the participant is considered fully consented. Normally this is both the Participant/Guardian and an Investigator.

To accomplish this, additional fields can be added to the consent form and blinded to the participant user role. For example, an additional handwritten signature, a name and and a date.

When the Participant fills out and saves the consent form, it will remain in an incomplete status until the other party accesses the same form from the mobile app to fill out their portion. Once that is done, the system will consider the Participant consented.

Hybrid e-consent/paper consent studies, or ones where e-consent is being enabled mid-study

If some patients will be e-consenting and others by some other means, such as paper, a couple of extra minor steps are needed before enabling e-consent on the whole study:

First, add a checkbox to the registration form and set the Paper Consent property. This is what the site will check on the registration form to prevent the system from enforcing electronic consent for specific patients.

Second, on the consent configuration, there is a button at the bottom to Add Informed consent to the existing study.

This is only needed if existing subjects who have already consented by other means, need 'paper consent' enabled so the system does not enforce electronic consent on them once the consent function is enabled as a whole. For this to work, those patients must also be on the newer version of the study containing the checkbox on the registration form as discussed above.

The mobile app subject manager will indicate which subjects are consented, not consented, or using paper consent.

Further reading

As Participants become registered in the study and consented, it will be tracked in the consent report. 

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