The system has eConsent rules built right in to make e-consent a streamlined part of study data collection, rather than trying to manage it through a separate process.
Patients can fill out their own consent forms and receive automatic verification of that consent along with copies of the documents that were agreed to. Rules can also be set to require re-consent when protocol changes require it.
This article walks through the setup and implementation of this function.
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 function and define which form the patient will be filling out as the consent form. Note, only forms set with the ePRO property will display in the dropdown list.
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 in the form builder.
3. Check which documents should be attached to the email that goes out. Site documents are the common option here. This is simply a list of upload fields from the site forms. Any document uploaded to that field will go out to subjects at the corresponding site. 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 - which is not as common.
4. Include any other email addresses which need to be copied on the email, such as the site Coordinator
5. Save the configuration
Please note, this function will only work if the study is an ePRO study where the subject email is getting registered on the registration form during enrollment/screening. Read more about configuring ePRO here.