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Configuring Consent

Setup and Implementation of Electronic Consent

Rather than trying to manage it through a separate or paper 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

Prerequisites:

  • Study is licensed to utilize the Consent and ePRO
  • The study is configured for ePRO
  • User has role permission access to Informed Consent, Configure informed consent

Once enabled, there will be an option under the study configuration menu "Informed Consent".

Mobile App:

2022-09-16_20-23-52-1

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

1. Enable the consent tracking function.

If consent tracking is enabled, the system will require patient consent prior to any other forms being accessible to both the Participant and Clinicians.

Read more below for information on setting up the study for hybrid paper consent where some of the subjects will be consenting via tradional means.

2. Define which form the patient will be filling out as the consent form. Only ePRO log forms will display as options here. Those are defined in the form properties.

3. Opt to send the Participant an automated email once consent is completed, and set which  email notification should go out. Email notification can be configured within the form builder.

4. If there are general documents that need to be sent to consented participants regardless of their site, this full list of files can be used to choose from. This is not commonly needed.

5. 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 file uploaded to that field for each site will be included as an attachment in the email to the Participant after they provide consent.

6.  Select which file upload field on the site documents should be mapped to a help button on the Consent form. This is optional but recommended so Participants can reference the site-specific study information directly on the form they are providing consent on. The only alternative to this is embedding all wording/content on the form itself, which is  more work than linking a pre-made document.

7. Include any CC email addresses which should be on the recipient list when consent verification is sent to the patient after they consent. For example, if a Study Coordinator or Study Administrator would also like to be copied on each Consent verification email.

8. This option will only show based on permission granted. It is a function used when adding hybrid consent to a study that is already running.

Be sure to save the configuration at the bottom of the page when finished.

 

Tips:

  • As Participants consent to the study, the Consent Report will track the history and allow Administrators to deploy new versions of consent, or force re-consenting in the future.
  • The subject manager will indicate which subjects are consented, not consented, or using paper 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 a date.

When the Participant fills out and saves the consent form, it will remain in incomplete status until the other party opens the form to fill out their own portion. Once that is done, the system will consider the Participant as consented.

When the Participant is the only party completing/signing the consent, they receive an emailed copy of the signed document. When a non-Participant party is added as a second signer, the automated email will not be sent with an attached document. The site must manually download it and send it to the Participant.

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 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, if some subjects already exist in the study, they need to be updated to reference the new paper consent option. On the consent configuration (#8 described above), there is a button to Add Informed consent to the existing study.

User must have role permission access to Populate all Patients with Paper Consent    

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.