Veeva eConsent is a set of features that allows you to consent participants into studies electronically.
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 |
| 1 |
Accept a Connected Study Invitation |
Site Staff |
Accepted a connected study invitation from your sponsor |
Connected Studies |
| 2 |
Create Study Participants |
Site Staff |
- Create participants and any necessary signatories in Study Connect.
- Adding contact information for the participants and their signatories determines how they can sign eConsent forms (either remotely on their own device or in person at the site).
|
Managing Participants in Study Connect |
| 3 |
Receive and Edit Form |
Sponsor and Site Staff |
- Receive a blank ICF from your sponsor in Study Connect.
- Add site-specific edits to the ICF in the Veeva eConsent editor. You can customize the form to include questions and answers, add media, or adjust the signature requirements.
- Approve the ICF for use.
|
|
| 4 |
Share Form With Sponsor |
Sponsor and Site Staff |
- Share the form and any site-specific edits with the sponsor for review.
- When the sponsor approves the site-specific ICF for use, you can send it to participants.
|
|
| 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. |
|
| 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. |
|
| 8 |
Countersign Form |
Site Staff |
Countersign the completed ICF in Study Connect. |
Countersigning eConsent Forms |
| 9 |
Review Responses |
Site and Sponsor Staff |
- Review the response data from the ICF if it includes questions.
- If the ICF is created by and connected to a sponsor, deidentified response data is also sent to the sponsor’s Clinical Operations Vault.
|
Viewing and Reporting on eConsent Form Responses |
Additional Workflows
You can also learn more about the following workflows related to eConsent forms:
Getting Started
See the following pages for information on how to get started with Veeva eConsent in Study Connect:
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.