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.
Veeva eConsent enables study participants, signatories, and site staff to sign informed consent forms (ICFs) electronically, eliminating the need to print the forms and speeding up the consenting process. Participants and their signatories can review the forms in the office or at home on a familiar device, can read at their own pace, and can easily download and share the forms with their family and care team. Additionally, participants with accessibility requirements can zoom in and utilize screen readers.
The process of consenting participants into a study using Veeva eConsent uses the following general steps:
- Sponsor or site staff create, edit, and approve the ICF or ICFs in Vault and the Veeva eConsent editor. They can customize the forms to include questions and answers, to add media, or to adjust the signature requirements.
- If the form is created by the sponsor, the sponsor shares the form with the site using Connected Studies or an import code. The site can then make site-specific edits.
- Site staff use features such as the preview link to facilitate IEC/IRB review.
- Site staff send the ICF or ICFs to the participant and their signatories (if additional signatories are needed) in SiteVault.
- The participant and signatories review, sign, and submit the study ICFs in MyVeeva for Patients in person or remotely.
- Site staff (the approver on the sent ICF) countersign the ICF in SiteVault.
- If the form included questions, the answers and signature records are recorded in SiteVault. Additionally, if the form was created by and connected to a sponsor, the deidentified response data is sent to the sponsor in Clinical Operations.
To learn about the participant’s experience during the consenting process, see the Consent page on the MyVeeva for Patients Help website.
See the following pages for information on how to get started with Veeva eConsent in SiteVault:
- Managing eConsent Forms: Learn how to create, edit, and approve eConsent forms in SiteVault.
- Consenting Participants: Learn how to send approved eConsent forms to participants to sign in MyVeeva for Patients and countersign them in SiteVault.
- Veeva eConsent Glossary: Learn more about common terms in Veeva eConsent.
- Troubleshooting Veeva eConsent and MyVeeva for Patients: Find help and answers to common eConsent and MyVeeva for Patients questions.
- SiteVault Training Resources: Find Veeva eConsent training resources.
To learn more about the help, troubleshooting, release, and known issue resources that are available for participants and site staff, see the MyVeeva for Patients Resources page.