eConsent

Manage study participants, digitize consent forms, and eConsent participants

Process Declined eConsent Forms

When a participant or signatory declines an eConsent form, the Veeva eConsent Status field for the document in SiteVault 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. If you want to hide declined eConsent forms in your library, you need to set up views to do so. 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. For more information on sending eConsent forms, see Start the Consent Process.

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