The system has eConsent rules built right 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 completion of a consent form and provide the patient access site-specific consent documents.
The following is possible with the e-consent capabilities:
- Subjects/patients can fill out their own consent forms and receive automatic email verification of that consent along with copies of the documents that were signed
- Subjects can view site-specific consent document.
- Consent can even be used to control other data entry for study subjects
- 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
This article walks through the setup and implementation of Consent.
This 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.
Important: If consent tracking is enabled, the system will require patient consent prior to any other forms being accessible to either the site or the patient.
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 extra minor steps are needed before enabling e-consent on the whole study:
First, add a checkbox to the registration form with the 'paper consent' property enabled. 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 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.
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. Here is an example:
3. If there are non-specific, or general, documents that go to all subjects regardless of their site, the full list of documents from the list can be used to choose from. This is not a common selection made.
4. A site document file for informed consent is the 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 subjects at the corresponding site.
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. Read more here on help buttons.
6. Save the configuration - Any other email addresses that should be copied (cc'd) on the consent confirmation that goes out to the patient. Note, this is not a blind copy.
Be sure to save the configuration at the bottom of the page when finished.
Check out the following links for further reading: