Summary

This article walks through the setup and implementation of Consent. 

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 or system.


The following is possible with the 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
  • 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 function will only work if the study is an ePRO study where the subject email is getting registered on the registration form.
 

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:


You may reference the annotated image below on the various functions defined on the screen:


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


Important: If consent tracking is enabled, regardless of the other settings, the system will require patient consent prior to any forms being accessible to either the site or the patient. The only exception to this is the designated Registration form, which is accessible regardless of consent status.


2. 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. This ‘Check Each Document to Attach’ option can be used if there are study level or general documents that should go to all subjects who consent, regardless of their site. Documents available for selection here are those that are uploaded to a Site or Study form, as part of a File Upload field type. When selected, the consent distribution email will include an attachment of the selected uploaded file.
 

Important: It is recommended that a Study form be created, and the document be uploaded to a field within a Study form. Study forms can accessed and completed under Study – Study Documents at the Web.


 

4. This ‘Select Each Site Document and Upload Field to Attach’ option can be used if there are Site specific documents that should go to subjects who consent. Documents available for selection here are those that are uploaded to a Site or Study form, as part of a File Upload field type. When selected, the consent distribution email will include an attachment of the selected uploaded file for the Site that the Subject was enrolled under.
 

Important: It is recommended that a Site form be created, and documents be uploaded to a field within the Site form for each designated Site. Site forms can accessed and completed under Study – Site Documents at the Web.



5. This ‘Select the eConsent Document to display…’ option can be used if there are specific documents that should be made visible to the Patient when they access the designated Consent Form (form data entry). Documents available for selection here are those that are uploaded to a Site or Study form, as part of a File Upload field type. The selected document will be visible at the form data entry screen as a Help Button (field type) when ‘Display Consent PDF’ is turned on at the Help Button Field Properties.


Important: If a document uploaded to a Site form is selected, detail for the selected document will be tied to the Site that the Subject was enrolled under.


6. Any other email addresses that should be copied (cc'd) on the consent confirmation that goes out to the patient can be added here. Note, this is not a blind copy.


 

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

Need more help?

Please visit the Datatrak Contact Information page.