eConsent

Manage study participants, digitize consent forms, and eConsent participants

eConsent Quick-Start Guide

Veeva eConsent provides a digital way to consent clinical trial participants in-person or remotely. Your patients can review documents and sign eConsents by using the MyVeeva for Patients mobile app. For more information about the MyVeeva for Patients app, see the MyVeeva patient website.
SiteVault is a standardized eISF with eConsent capability, managed by your site. Here’s what you need to know:
  • Complete Control: You never lose access to your records, making them easily accessible for audits and inspections. You can even add your monitor/auditor to the system to conduct their review.
  • Patient Technology: Patients can use the MyVeeva for Patients app for eConsent, eCOA, Visit Reminders, and Documents.
  • Consistent Process: The steps below are the same across all studies where you choose to enable eConsent.
For an overview of SiteVault functionality, see Welcome to Veeva SiteVault.

How To Use this Guide

This guide walks you through the eConsent steps and connects you to the help content associated with each step. All of the links below are available on the eConsent Help tab; this guide just organizes the content for those new to the process.

When you select a link, it will open the related help content in a new tab; this guide remains open so you can easily return to navigate to the next step.

Stage One: SiteVault Setup

# Step Description
1 Sign Up for SiteVault

Register your site for SiteVault and sign the terms of service. Veeva eConsent is not a sponsor-specific platform; you can use it on any of your studies.

  1. Complete the SiteVault sign up form.
  2. Watch for emails with your site's registration information and your login credentials.
2 Add Your Study Team

Ensure all staff members who are consenting participants are added to the system as users, added to the study team, and set to the Active state on the study.

  1. Create Staff user accounts.Video support is included on the help page.
  2. Assign Staff users to the study by creating Study Team Assignments.Video support is included on the help page.
  3. Make sure you set each Assignment Status to Active.

Stage Two: Form Preparation

Using the eConsent Editor, you can create and edit eConsent forms. Once the form has met your standards and any local IRB requirements, you can approve it for use.

# Step Description
1 Create an eConsent Form (optional)
  1. Create a new consent form using the eConsent editor. Edit the form as needed. Video support is included on the help page. The editor is an extension of SiteVault accessed by selecting the edit action associated with the form. Video support is included on the help page. The editor is an extension of SiteVault accessed by selecting the edit action associated with the form.
  2. After editing, preview the form again and share again, if an additional review is required.
2 Preview and Share an eConsent Form

You can preview a blank consent form just as a patient would through the MyVeeva for Patients app. You can share the preview link with others if an additional review is required.

  1. Preview the form for accuracy.
  2. Share the preview link with others, if an additional review is required.
3 Approve the eConsent Form

This step will approve the blank eConsent form, moving it to the Approved for Use state.

  1. When a blank eConsent form has met the prerequisites, you can select Approve for use.
  2. If the option to Approve is not present, review the eConsent form prerequisites.

Stage Three: Signatures

# Step Description
1 Create Participants

Over time, patients may participate in multiple studies. For this reason, a study participant requires a participant record and a patient record. This allows the patient record to be associated with multiple study participant records.

  1. Create a study participant and patient or associate with an existing patient record. Video support is included on the help page.

If this study is also using Veeva eCOA, the Patient and Participant information will transfer from SiteVault to Veeva eCOA after you connect. For more information, see eCOA help.
2 Start Consenting Participants

With your eConsent form in the Approved for Use state and participants in your study, you can start the consent process.

  1. Select the Start Consent action for the study participant. Video support is included on the help page.
  2. The instructions first offer the option to sign in-person; you can select the X to close if the patient isn't present.
  3. If the patient is present, review the consent form with them. All sections and required questions must be completed before a signature can be applied.
3 Site Countersignature

The site staff who initiated the consent process is automatically assigned the task to apply the countersignature. The original assignee has the option to reassign the task in the task's Action Menu (...). Once the task is completed the document is moved to the Current state and available for monitor review.

  1. The site staff assigned the task can access the SiteVault Home page, notifications, or the task email notification for the link to apply the countersignature.
  2. The consent form question responses are available for your review in SiteVault.

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