Learn how to reconsent a participant if they need to re-sign a consent form.
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.
Reconsenting a Participant
If you need to reconsent a participant, you can send either the same version or a new version of the blank ICF that the participant and signatories signed before. Additionally, you don’t need to send an updated version if you sent the previous Approved for Use version to the participant and the participant or their signatories haven’t signed yet. The MyVeeva user always sees the latest approved version in MyVeeva for Patients up until the point when they sign.
To reconsent a participant, complete the following steps:
- Ensure that the new version of the blank ICF is in an Approved for Use state and that the prerequisites described on the Consenting Participants page are met. To update an existing approved ICF, you can select Create Draft from the All Actions menu, select Copy File From Current Version then edit, check in, and approve the ICF when it’s ready.
- Repeat the steps on the Consenting Participants page and send the latest approved version of the ICF or ICFs.
Note When you send a new version of an ICF to a patient, the eConsent form displays on their list of documents as a new version. When they sign and submit the new version, it's added to SiteVault and the approver is assigned a task to countersign the new version.