Consenting Participants

Learn how to send approved eConsent forms to participants and their signatories to sign in MyVeeva for Patients.

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.

Prerequisites

The following prerequisites must be met before you can send an eConsent form to a participant:

Prerequisite

Description

Documents

Blank ICFs must meet the following prerequisites in order to be sent:

Workflow History: The blank ICF must be in the Approved For Use status.
Study: The blank ICF must be for the study.
Veeva eConsent: The blank ICF must be in the eConsent library on the Blank Forms tab in Study Connect.

Additionally, you can’t send a blank ICF that has already been sent and is still with the participant. These in-progress ICFs are displayed in the eConsent Form dialog (denoted with an orange In Workflow icon), but you cannot select them.

Participants and Signatories

The following prerequisites must be met in order to send a blank ICF as an eConsent to a participant or signatory:

Participant: A participant record must exist. The contact information in the participant record determines how they can sign eConsent forms:

If	Then
The participant record contains a valid email address and phone number capable of receiving SMS messages when you send them an eConsent form	The participant is required to create a MyVeeva for Patients account or log in to their existing MyVeeva for Patients account to sign the eConsent form. This applies to remote signing and in-person signing.
The participant record doesn't contain a valid email address and/or phone number capable of receiving SMS messages when you send them an eConsent form	The participant must either: Sign the eConsent form in person at the site and hand-draw their signature in MyVeeva for Patients. See Sending eConsent Forms to Participants to Sign In Person. Create a PIN using a Device Registration Code to register in MyVeeva for Patients and sign the consent form remotely on their own device. See Creating a Device Registration Code for a Participant.

Additional Signatories: If applicable, create records for any additional signatories such as a guardian or witness. The contact information in the signatory's record determines how they can sign eConsent forms.

If	Then
The signatory's record contains a valid email address and phone number capable of receiving SMS messages when you send them an eConsent form	The signatory is required to create a MyVeeva for Patients account or log in to their existing MyVeeva for Patients account to sign the eConsent form. This applies to remote signing and in-person signing.
The signatory's record doesn't contain a valid email address and/or phone number capable of receiving SMS messages when you send them an eConsent form	The participant must either: Sign the eConsent form in person at the site and hand-draw their signature in MyVeeva for Patients. See Sending eConsent Forms to Participants to Sign In Person. Create a PIN using a Device Registration Code to register in MyVeeva for Patients and sign the consent form remotely on their own device. See Creating a Device Registration Code for a Participant.

See the Managing Participants in Study Connect page for information on creating or updating participant and signatory records.

Note MyVeeva for Patients users can update their email address and phone number in the MyVeeva for Patients Android, iOS, or web applications after they register their account. The information is automatically updated in SiteVault and your Site Administrator users are notified of the change.

When your blank ICF or ICFs for the study are in the Approved for Use state and the participant and any applicable signatory records exist, you can send ICFs for signature in Study Connect. You don’t need to know whether the participant or signatory already has a MyVeeva for Patients account in order to send them an eConsent form.

If they don’t already have an account for the email address entered in Study Connect, they’ll be prompted to register when they access MyVeeva for Patients from the invitation email or in-person consent code.
If they already have an account for the email address entered in Study Connect, they can log in and access the documents for your study.

If the prerequisites above are met, complete the following steps to send an ICF to a participant and their signatories to review and complete:

In Study Connect, select eConsent on the left menu.
On the Participants tab, locate the participant beneath the Patient Name column and select the Send eConsent icon ().
In the Send Consent Document pop-up, select the ICF or ICFs you want to send to the participant and select Next.
If necessary, select any applicable signatories on the Signatories page.
Select Send. If the participant has not signed a version of the blank ICF before, a placeholder document is added to the list of documents for the participant. If the patient has signed a previous version and this is a reconsent, a new minor version is added to the signed ICF.

See the Troubleshooting Veeva eConsent and MyVeeva for Patients page for more information about issues that participants may encounter.

You can create and scan an in-person QR consent code to have participants or other signatories complete eConsent forms in person using a site’s device. A participant or signatory can scan the QR code or go to the web address shown onscreen to access MyVeeva for Patients. This in-person consenting functionality bypasses the invitation email and makes it easier to have participants and signatories complete eConsent forms at the office or another location where they may not have their own device. Patients who consent in person must electronically sign during an in-person consenting session and hand-draw their signature in place of dual-factor authentication.

Complete the following steps to have participants or signatories complete eConsent forms in person:

In Study Connect, select eConsent on the left menu.
On the Participants tab, locate the participant beneath the Patient Name column and select the View In-Person Code icon (). The in-person QR code is displayed in a new tab of your browser window.
Scan the QR code with a tablet or mobile device. The MyVeeva for Patients web app is opened in the device’s browser, and the participant or signatory can review and complete the consent forms. See the Consent Forms page in MyVeeva for Patients Help to learn more.

Note If signatories are associated with the participant and completing forms, you’ll select the users one at a time on the device. After you select a user, they can log in and complete the forms, and after they finish, you can select the next one.

When the participant completes all their documents, they’re logged out automatically after 30 seconds of inactivity or if the browser is closed.