If the eConsent prerequisites are met, complete the following steps to send consent forms to a participant or signatory to review and complete while at the site or remotely:

1. Navigate to Studies and select a study.
2. Select the Participants tab.
3. Select Start Consent from the participant’s Action menu or Participant Detail page.
4. SiteVault will review the status of the participant’s consent forms and navigate you to one of the two following processes below:

Select and Assign Consent Forms

1. Select one or more blank forms.
2. Select Next.
3. Review form and signatory information. Edit if necessary.
   • A maximum of two witness, two caregiver, and two guardian signatories can be selected per form.
4. If the participant or signatory does not already have a MyVeeva account, provide them with the app download QR code and the Activation Codes needed to activate their account and access the consent forms.
5. Select Confirm Selection.
6. Confirm the participant or signatory’s preferred signing option and begin consent. See Step 2 below.

Initiate the Review and Completion of Pending Consent Forms

If there are pending consent forms, you are directed to these steps to complete consent.

1. If additional forms must be added, select the Add Additional Consent Forms link and follow the prompts.
2. Select one of the following methods and follow the system instructions:
   • In-Person using Site Device
     • To review with the device in use, select Start Now.
     • To review with a different device, scan the QR code to download the app.
   • In-Person using Participant Device
     • To review without a MyVeeva for Patients account, scan the QR code.
     • To review with a MyVeeva for Patients account, advise the participant/signatory to log into the app. Select Generate Code if the participant/signatory is adding the app and/or activating an account for the first time. Generate codes for all signatories who require one. Provide the participant/signatory with the QR code to download the app and the activation code to activate an account.
   • Remote Consent
     • Advise the participant/signatory to log into the app. Select Generate Code if the participant/signatory is adding the app and/or activating an account for the first time. Generate codes for all signatories who require one. Provide the participant/signatory with the QR code to download the app and the activation code to activate an account. To view the participant experience, see the Remote eConsent Interactive Demo.

Collect Consent Signatures in Wet Ink

If you need to consent a participant in wet ink, complete the following steps:

1. Download and print the blank form.
2. Request that all signatories sign the appropriate signature blocks in wet ink.
3. You sign the site signature block.
4. Upload a scanned copy of the form to SiteVault with the Informed Consent Form (signed) document type.

For more information, see Troubleshoot eConsent and MyVeeva for Patients.