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 have at least one Approved for Use version.
  • Study: The blank ICF must be for the study. You enter the study in the document’s Study field.
  • Veeva eConsent: The blank ICF must be an eConsent document as indicated by the Veeva eConsent field. The system automatically sets the Veeva eConsent field to Yes when you create a blank ICF, and the field is used to distinguish eConsent ICFs from paper ICFs.
  • Language: The blank ICF’s Language field must accurately reflect the document content language.

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:

  • Language: The participant's selected language will limit the available consent forms. If an appropriate eConsent is not available, confirm the accuracy of the document and participant languages and adjust if possible.
  • Patient: A patient record must exist. The contact information in the patient record determines how they can sign eConsent forms:
  • If Then
    The patient 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 patient 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 patient is required to 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 below for more information.
  • Participant: A participant record must exist for the patient and study and must be linked to the patient record.
  • Additional Signatories: If applicable, create records for any additional signatories such as a guardian, witness, or caregiver. 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 signatory is required to 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 for more information.

See the Managing Patients and Managing Study Participants pages for information on creating or updating patient, signatory, and participant 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.

Sending eConsent Forms to Participants to Sign Remotely In MyVeeva for Patients

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 an eConsent form to a participant for them to sign remotely with their own device in MyVeeva for Patients. 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 SiteVault, 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 SiteVault, 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:

  1. Access the study and expand the Participants (Subjects) section.
  2. Select the linked ID in the Study Participant ID column. The participant record is displayed.
  3. Select Send eConsent from the participant’s All Actions menu. The Send eConsent dialog box is displayed.

Tip You can also send eConsent forms by selecting Send eConsent from the actions menu next to the linked participant ID on the participant list, but we recommend checking the status of the participant’s documents on the participant record after you send eConsent forms to verify that they were delivered.

  1. Search for and select the ICF or ICFs that you want to send to the participant. The documents displayed are filtered per the prerequisites listed above for the documents.
  2. Select Next. The Signatory page of the dialog box is displayed.
  3. Review the list of signatories to ensure that the list of signatories and their contact information are correct. Select or deselect signatories as needed. If you’re sending more than one ICF, select Next to proceed to the next ICF, or select Previous if you need to return to a previous step.
  4. Select Send. If the patient 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.

Sending eConsent Forms to Participants to Sign In Person

Example QR code

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:

  1. Navigate to and open the record for the study participant. If not already sent, select Send eConsent from the All Actions menu to send the ICF to the participant and signatories.
  2. Select View In-Person Code from the All Actions menu. The in-person QR code is displayed in a new tab of your browser window.
  3. 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.

Consenting Participants In Wet Ink

If you need to consent a participant in wet ink, you can add a site signature block to your study’s eConsent form template. You can print the blank form and have all signatories sign the form in wet ink: the participant and signatories sign their applicable signature blocks, and you sign the site signature block. You can then upload a scanned copy of the form to SiteVault as an Informed Consent Form (signed) document type.

For more information about adding a site signature block to an eConsent form, see the following help topics:

To upload a scanned copy of a signed eConsent form to SiteVault, follow the Creating Study Documents workflow.


Creating, Editing, Previewing, and Approving eConsent Forms
Locking and Unlocking eConsent Forms
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