Tracking eConsent Forms

Learn how to track and trace eConsent forms by learning about their statuses in Study Connect.


Note Veeva eConsent may be provided by your sponsor for use on a Connected Study or enabled for your SiteVault account as a paid add-on to use across all studies. Contact the Site Success Team to learn more.

Tracking the Veeva eConsent Status

You can view the Veeva eConsent status of ICFs in the following locations:

  • Blank Forms Tab: You can view the status of blank ICFs in the Status field on the Blank Forms tab in Study Connect.
  • Signed Forms Tab: You can view the status of signed ICFs in the Status field on the Signed Forms tab in Study Connect.
  • Participant Record: You can view the status of the ICFs sent to a participant in the Signed Consent Forms section of the participant’s page.
  • Form Responses Section: You can view the status of a participant’s or signatory’s signature in the Form Responses section of the participant’s page.

While the ICF is waiting on the participant and signatory signatures, the document status (the value in the Status field) is Draft. The Veeva eConsent Status field located on the Signed Forms tab and the Signed Consent Forms section on the participant’s page provides more detailed information regarding the status of the eConsent form that was sent to the participant. Signed (or sent) ICFs can be in the Veeva eConsent statuses below. Typically (if no error or delay in processing occurs), documents will be in a Delivered, Viewed eConsent, Signed, or Declined status. You may need to refresh the page several times before a document progresses from Initiating to Delivered.

Status Description
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, and the MyVeeva for Patients system 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. See the Prerequisites section and the Troubleshooting Veeva eConsent and MyVeeva for Patients page for more information.

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

For traceability purposes, you can view which version of an approved blank ICF a signed ICF was created from. To view the approved blank ICF version of a signed ICF, complete the following steps:

  1. In Study Connect, select eConsent on the left menu.
  2. On the Participants page, select the participant beneath the Patient Name column. The participant’s page opens.
  3. Scroll to the Signed Consent Forms section and locate the signed form.
  4. Select View beneath the Blank Forms column. The document viewer opens in a new window and the blank ICF version of the signed ICF is displayed.

Locking and Unlocking eConsent Forms
Countersigning eConsent Forms
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