Creating, Editing, Previewing, and Approving eConsent Forms

Learn how to create, edit, preview, and approve eConsent forms in SiteVault.

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.

Creating and Copying an eConsent Form

You can create a PDF-based eConsent form by creating a document from a template, a Microsoft Word™-based eConsent form by uploading the .DOCX file into Vault, or either type by copying an existing form.

If you want to collaborate in Microsoft Word™ while authoring a form, we recommend uploading a .DOCX file to Vault. If you want to edit primarily in the Veeva eConsent editor, we recommend creating the document from a template. If you use a Word-based eConsent form, edit the form in the Veeva eConsent editor to format items such as signature blocks, question blocks, images, and videos.

When you import a document into Vault to create an eConsent form, the file format will be maintained for the life of the form. A .PDF eConsent form will maintain its .PDF format in any later versions, and a .DOCX eConsent form will maintain its .DOCX format in any later versions.

Creating a New eConsent Form From Template (PDF)

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. Enter any other necessary details in the General fields.
  7. To the right of the Veeva eConsent field, select Yes.
  8. Select Save.

Creating a New Word-Based eConsent Form

Complete the following steps to create a new eConsent form based on a Microsoft Word™ document:

  1. Ensure that your .DOCX file is formatted per the guidelines outlined in the Import Guidelines in the Using the Veeva eConsent Editor page in Clinical Operations Help.
  2. From your Vault, select Create and then Document.
  3. Select Upload.
  4. Either drag-and-drop the .DOCX file into the box or browse for and select it. The maximum file size is 10 MB.
  5. Set the file type as Informed Consent Form (blank).
  6. Enter the ICF’s language, the name of the study, and any other necessary details in the General fields.
  7. Beside the Veeva eConsent field, select Yes.
  8. Select Save.
  9. Confirm that the upload was successful in the preview pane.
  10. From the All Actions menu, select Edit eConsent.
  11. Review the ICF in the Veeva eConsent editor and confirm the document imported correctly.
  12. Use the eConsent editor to create and edit the ICF’s sections, content blocks, question blocks, and signature blocks. For more information, see the Working With Sections and Content Blocks section in Clinical Operations Help.
  13. When you finish editing the ICF in the eConsent editor, select Check In.

Note The version of the Microsoft Word™ document you import and intend to approve for use must be reviewed, edited, and checked in to Vault from the eConsent editor prior to approval. If you import a Microsoft Word™ document and approve it without reviewing it, editing it, and checking it in to Vault from the eConsent editor, errors occur.

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 All 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 All Actions menu.
  3. Ensure that the Copy File From Current Version option is selected.
  4. Select OK.

Editing an eConsent Form

Note A sponsor has the option to restrict editing for a block, section, or entire form. If you can’t edit a section that needs to be updated, contact your sponsor.

  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 All 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 Using the Veeva eConsent Editor in Clinical Operations Help to learn more about how to use the Veeva eConsent editor.

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 IEC/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 All Actions menu on a blank ICF. The preview is opened in MyVeeva for Patients in a new tab of your browser.

Note You can’t open the preview from SiteVault for an eConsent form that is currently checked out. Check in the document to access and share the preview.

  1. 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.
  2. 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 You can also download and import eConsent forms as Microsoft Word (.DOCX) files in the Veeva eConsent editor. See the Downloading eConsent Forms and Importing Microsoft Word Documents sections in Clinical Operations Help to learn more.

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.

Approving an eConsent Form 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 Workflow 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 Managing Study Documents for more information.

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