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

Patient Consent Options

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.

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.

Connected Studies vs. Independent

Connected Study: A sponsor may require study sites to use SiteVault and Veeva eConsent to exchange forms and manage the patient consent process. In these situations, the sponsor will send the site (through SiteVault) an invitation to connect their Veeva Clinical Vault with the site’s SiteVault. This creates a simplified and secure connection to share documents for review and approval.

Independent: A site can choose to manage patient consenting for one or all of its studies using Veeva eConsent.

About Creating or Copying eConsent Forms

You can create a PDF-based eConsent form by creating a document from a Microsoft Word™-based eConsent form by uploading the .DOCX file into Vault, or either type by copying an existing form.

If you want to collaborate in Microsoft Word™ while authoring a form, we recommend uploading a DOCX file to Vault. If you use a Word-based eConsent form, edit the form in the Veeva eConsent editor to format items such as signature blocks, question blocks, images, and videos.

When you import a document into Vault to create an eConsent form, the file format will be maintained for the life of the form. A .PDF eConsent form will maintain its .PDF format in any later versions, and a .DOCX eConsent form will maintain its .DOCX format in any later versions.