Learn how to process eConsent forms that are declined by participants 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.
Processing Declined eConsent Forms
When a participant or signatory declines an eConsent form, the Veeva eConsent Status field for the document in Study Connect is updated to Declined and a notification is sent to the approver. The notification enables the site staff to perform any actions required by their organization. For example, the site staff may need to update the candidate’s status or not collect certain biosamples at the next visit. When any signatory declines an eConsent form, it’s also declined for any signatory who hasn’t signed it.
The signed ICF is displayed on the participant’s list of documents and retained in the library to maintain your records. You can’t cancel a declined eConsent form.
If a participant declined the form in error or changed their mind, you can resend the form. When you resend a previously declined form, a new minor version is added to the signed ICF. See the Consenting Participants page for more information