eConsent 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.

eConsent Form Creation and Management

SiteVault provides all of the tools required to:

Create eConsent forms
Edit eConsent forms
Share eConsent forms for review
Approve eConsent forms for use

Veeva eConsent provides your site with several consent options so you can meet your patients’ comfort levels.

Remote eConsent: Patients can sign electronically from a mobile device using the MyVeeva for Patients application.
On-site eConsent: Patients can sign electronically at your site with your technology.
On-site Wet Signature: You can print a consent form for your patient to sign.

To view the remote experience, see the Remote eConsent Interactive Demo.

eConsent Tracking and Management

Once signed, eConsent response details are available to you in an online rendering of the consent form and captured in the system for efficient review and searching.

eConsent Document Formats (eConsent Type)

eConsent forms can be uploaded in the PDF filetype or DOCX (Word). When you import a document into SiteVault to create an eConsent form, the file format will be maintained for the life of the form (including later versions). After upload, SiteVault’s eConsent editors are used to add question and signature elements.

eConsent Editors

PDF-Based eConsent Editor

With the PDF-Based eConsent Editor, site users can overlay question and signature elements directly onto PDF consent forms. Uploading IRB-approved PDF consent forms avoids additional IRB reviews after digitizing.

Custom eConsent Builder (Microsoft Word™)

You can create an eConsent form by importing content from a Word-based document and editing in the Custom eConsent Builder to format items such as signature blocks, question blocks, images, and videos.

Browser and Device Prerequisites

To have the best experience using the eConsent editors, ensure that your browser and device meet the following requirements:

Browser: We recommend that you use a desktop browser for the editors. You’ll have the best experience in Google Chrome, Microsoft Edge, or Mozilla Firefox.
Pop-Up Blockers: If you use Apple Safari or Mozilla Firefox to edit an eConsent form, you must configure your browser to allow pop-ups from the SiteVault website.
Resolution: If your screen is smaller than 960 pixels wide or you zoom in to an equivalent width, you may not be able to use some functionality such as the table of contents and the buttons for saving to SiteVault or checking in.