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 |
Actions |
Help |
| If your study is connected to a sponsor's study in Clinical Operations, follow Steps 1 and 1a. If your study isn't connected to a sponsor's study, follow Step 1 and continue to Step 2. |
| 1 |
Create Form |
Sponsor or Site Staff |
- Create the ICF in Vault.
- Edit and customize 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 in Vault.
|
|
| 1a |
Share Form
(Optional) |
Sponsor and Site Staff
(If using a form connected to a sponsor) |
- Share the form with the site using Connected Studies.
- Site staff can then make site-specific edits to the ICF using the Veeva eConsent editor, if necessary.
|
|
| 2 |
IEC/IRB Review |
Site Staff |
- Copy and share the ICF’s preview link to facilitate IEC/IRB review.
|
Previewing and Sharing an eConsent Form |
| 3 |
Send Form |
Site Staff |
Send the ICF to the participant and their signatories (if additional signatories are needed) from SiteVault. The participant can either register a MyVeeva for Patients account to consent remotely or consent in person at your site. |
Consenting Participants |
| 4 |
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. |
|
| 5 |
Countersign Form |
Site Staff |
Site staff countersign the completed ICF in SiteVault. |
Countersigning eConsent Forms |
| 6 |
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 SiteVault:
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.