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.
Overview
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.
General eConsent Workflow
The process of creating eConsent forms and consenting participants into a study using Veeva eConsent uses the following general steps:
# | Step | Role | Action | Help |
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1 | Accept a Connected Study Invitation | Site Staff | Accepted a connected study invitation from your sponsor | Connected Studies |
2 | Create Study Participants | Site Staff |
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Managing Participants in Study Connect |
3 | Receive and Edit Form | Sponsor and Site Staff |
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4 | Share Form With Sponsor | Sponsor and Site Staff |
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5 | IEC/IRB Review | Site Staff | Copy and share the ICF’s preview link to facilitate IEC/IRB review. | Previewing and Sharing an eConsent Form |
6 | Send Form | Site Staff | Send the ICF to the participant and their signatories (if additional signatories are needed) in Study Connect. |
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7 | Sign Form | Participants and Signatories | Participants and signatories review, sign, and submit the ICF in MyVeeva for Patients, either remotely or in person at your site. |
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8 | Countersign Form | Site Staff | Countersign the completed ICF in Study Connect. | Countersigning eConsent Forms |
9 | Review Responses | Site and Sponsor Staff |
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Viewing and Reporting on eConsent Form Responses |
Additional Workflows
You can also learn more about the following workflows related to eConsent forms:
- Processing Declined eConsent Forms
- Canceling eConsent Forms
- Translating eConsent Forms in SiteVault eRegulatory Help
Getting Started
See the following pages for information on how to get started with Veeva eConsent in Study Connect:
- Managing Participants in Study Connect: Learn how to create, view, edit, and withdraw study participants in Study Connect.
- Viewing, Editing, Previewing, and Approving eConsent Forms: Learn how to view. edit, preview, and approve eConsent forms for use in Study Connect.
- Consenting Participants: Learn how to send approved eConsent forms to participants to sign remotely or in person at your site using MyVeeva for Patients.
- 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.
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.