eConsent

Manage study participants, digitize consent forms, and eConsent participants

Track Participant eConsent Form Status

Several participant eConsent statuses are available to provide insight into several processes.

The Participant’s Consent Status provides a quick summary as to whether or not a participant has consented. This status is located on the Participant Details page and in the Participant View Details panel. This status updates automatically when a participant signs or declines an eConsent form, however, you can update the status manually as needed.

The possible statuses are:

  • Not Consented
  • Consented
  • Reconsent Needed

Veeva eConsent Status

The Veeva eConsent Status provides a more technical view of the form in the MyVeeva for Patients app. This status advises if the document was successfully received, accessed, or signed in the app, as well as if there were any hurdles in the delivery. This status is located by accessing the Consent Forms tab of the Participant Details page.

The possible statuses are:

  • Delivered: The eConsent form was delivered to the participant. If contact information was provided, an invitation to view the eConsent forms for your study in MyVeeva for Patients should be in the participant’s email.
  • Viewed eConsent: The participant viewed the eConsent form in MyVeeva for Patients but has not yet completed the form.
  • Signed: The participant and any additional signatories signed and submitted the eConsent form in MyVeeva for Patients.
  • Countersignature Needed: All MyVeeva users signed and submitted the eConsent form in MyVeeva for Patients, and the document is ready to be assigned to site staff for countersignature in SiteVault.
  • Site Signed and Final: All MyVeeva users and all applicable site staff signed the eConsent form.
  • Declined: The participant declined the eConsent form in MyVeeva for Patients.
  • Site Declined: Site staff declined the eConsent form that the participant signed and submitted in MyVeeva for Patients.
  • Initiating: The SiteVault system is sending the eConsent form to the MyVeeva for Patients system.
  • Processing: The SiteVault system successfully sent the eConsent form to the MyVeeva for Patients system, which is processing the delivery.
  • Error: The SiteVault system sent the eConsent form to the MyVeeva for Patients system, but the operation failed for an unrecoverable reason.
  • Delivery Failed: The MyVeeva for Patients system was unable to deliver the eConsent form to the patient. This is likely due to an incorrect email address. For more information, see Consenting Participants and Troubleshooting Veeva eConsent and MyVeeva for Patients.
  • Viewing Failed: The patient was unable to view the eConsent form in MyVeeva for Patients.
  • Not Applicable: This document isn’t a Veeva eConsent form. This status is the default status and is used for signed ICFs that are not eConsent forms (paper ICFs).

Tracing Signed ICFs and Approved Versions

To view which version of an approved blank eConsent form was used to create a signed eConsent form:

  1. Navigate to Studies.
  2. Select a study.
  3. Select Participants.
  4. Select a Participant.
  5. Select Consent Forms.
  6. Review the Blank Forms column.
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