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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 other further data entry for study subjectsof 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
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Table of Contents
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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.
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Be sure to save the configuration at the bottom of the page when finished. |
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.
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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. |
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Hybrid e-consent/paper consent studies, or ones where e-consent is being enabled mid-study
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