eConsent Process

Learn about the eConsent process and tools

Track eConsent Form Status

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:

  • Document: You can view the status of the ICFs in the Veeva eConsent Status field on signed ICFs and placeholders.
  • Participant: You can view the status of the ICFs sent to a participant in the Documents section of the participant record.
  • Additional Signatories: You can view the status of a participant’s or signatory’s signature in the Form Responses section of the participant record.

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 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 Consenting Participants page 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 in the Approved ICF Version section of the signed ICF’s document information.

You also can select Where Used from the All Actions menu on a blank ICF to see the signed ICFs that were created from it.