Managing eConsent Forms

Learn how to create and approve eConsent forms in SiteVault.

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Creating and Copying eConsent Forms

Creating a New eConsent Form

Complete the following steps to create a new eConsent form based on the template:

  1. In the Documents > Library tab, select Create. The Create Document dialog is displayed.
  2. Select Document from Template, then select Continue.
  3. Search for and select Informed Consent Form (Blank) in the Choose Document Type field.
  4. Select Veeva eConsent Template from the Choose Template list. The template provided by Veeva includes sections that are often included on ICFs, but you’ll need to add the required information for your study and edit the sections as needed.
  5. Select Next.
  6. Search for and select a study.
  7. Enter any other information as needed.
  8. Select Save.

Copying an Existing eConsent Form

You can also create a new eConsent form by copying from an existing study’s form. Complete the following steps to do so:

  1. Find the document you want to copy.
  2. Select Make a Copy from the Actions menu.
  3. Ensure that the Copy Content checkbox is selected. Optionally, you can also select the Copy Fields checkbox, but you may need to update the fields to apply to the new blank ICF.
  4. Select Continue.
  5. Update and enter any other information as needed.
  6. Select Save.

Creating a New Draft of an eConsent Form

Complete the following steps if you need to update (to create a new draft) of an eConsent form:

  1. Find the document that you want to update.
  2. Select Create Draft from the Actions menu.
  3. Ensure that the Copy File From Current Version option is selected.
  4. Select OK.

See the Reconsenting a Participant section of the Consenting a Participant page for information about the reconsenting process.

Editing an eConsent Form

Complete the following steps to access the Veeva eConsent editor and edit an eConsent form:

  1. Access the blank ICF that you want to edit. The blank ICF must be a new ICF that isn’t approved for use or a new draft version of a previously approved ICF. Additionally, the blank ICF can’t currently be checked out to another user. See the sections above for more information.
  2. Select Edit eConsent from the Actions menu. The blank ICF is checked out, and the Veeva eConsent editor is opened in a new browser tab.
  3. Edit the eConsent form as necessary.
  4. When you’re ready to save to Vault or check in the document, select Save to Vault or Check In above the table of contents in the editor. Your progress is also saved automatically in the editor every 30 seconds.

See the Editing eConsent Forms page on the MyVeeva for Patients website to learn more about how to use the Veeva eConsent editor.

Approving an ICF for Use

When you’ve checked in the blank ICF from the Veeva eConsent editor, completed any necessary reviews, and are ready to approve the ICF for use, complete the following steps:

  1. Access the blank ICF that you want to approve.
  2. From the document Actions menu, select Change State to Approved for Use. The Change Status to Approved for Use dialog is displayed.
  3. Select a date in the Document Date field.
  4. Select Start.

See Document Lifecycles & Workflows for more information.

Previewing and Sharing an eConsent Form

You can preview a blank ICF if you want to view the participant experience of the eConsent form. You can also share a link to the preview with third parties such as an EC/IRB. External users can view the preview without a SiteVault or MyVeeva for Patients account. The preview link expires after 30 days, and if you delete the blank ICF, you or external users can no longer view the preview link.

The preview opened from SiteVault is version-specific. For example, you can share a preview of a draft version of an eConsent form or you can share a version that’s approved for use.

Complete the following steps to preview and share an eConsent form:

  1. Select Open Preview Link from the Actions menu on a blank ICF. The preview is opened in MyVeeva for Patients in a new tab of your browser.
  2. If you want to share the preview, copy the web address of the preview and share it as needed. The name of the user who created the preview, the date it was created, and the date it expires all are displayed on the Preview Mode banner. A mock Participant Preview user is displayed on the menu and used for the signature.
  3. If you want to preview the eConsent form, click through it as a participant would in MyVeeva for Patients. Items are marked complete on the table of contents as you view or otherwise complete them. You or an external user can interact with the preview to see how participants sign, submit, decline, and download the .PDF files, but the information is not saved to MyVeeva for Patients or SiteVault.

Note While you’re editing an eConsent in the Veeva eConsent editor, you may notice the Web Preview button in the upper-right corner. The Web Preview button allows you to preview your edits while you work and before you’re ready to share them. This web preview can’t be shared.

Consenting Participants