eConsent

Manage study participants, digitize consent forms, and eConsent participants

Quick-Start Guide for Connected Studies

Did a sponsor invite you to learn about SiteVault and Veeva eConsent? You're in the right place!

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.
  • Sponsor Connection: Your sponsor connects to SiteVault to send you consent forms, but you can use all SiteVault features for any study, any sponsor.
  • Patient Technology: Patients can use the MyVeeva for Patients app for eConsent, ePRO, Visit Reminders, and Documents.
  • Consistent Process: The steps below are the same across all studies and sponsors.
For an overview of SiteVault functionality, see Welcome to Veeva SiteVault.
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.

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 a connected study with a sponsor or use it on any of your studies, without a sponsor connection.

  1. Complete the SiteVault sign up form.
  2. Watch for emails with your site's registration information and your login credentials.
2 Accept the Study Invitation to Connect to Sponsor

You own and control the data in your SiteVault; accepting the study invitation from your sponsor or CRO indicates that you agree to use SiteVault and the connection to exchange eConsent documents. Sponsors cannot access your SiteVault or view your activities. This connection only provides the ability to securely exchange forms.

  1. Follow the instructions to Accept an eConsent Invitation.
3 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

Your sponsor can send you blank eConsent forms through SiteVault. You can preview a form and if necessary, edit with the eConsent Editor, which is an extension of SiteVault. Once the form has met your standards and any local IRB requirements, you can approve it and send it back to the sponsor.

# Step Description
1 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.
2 Edit an eConsent Form (optional)
  1. Edit the blank form using the eConsent Editor. 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.
3 Approve the eConsent Form and Send it to the Sponsor

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

  1. When a blank eConsent form has met the prerequisites and the study is a connected study (your SiteVault is connected with the sponsor's Vault), you can select to Approve and Send.
  2. If the option to Approve and Send 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. Video support is included on the help page.
  2. Create and associate a patient with the participant (or associate with an existing patient record).

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.

Additional Resources

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