Overview of Editing eConsent Forms

eConsent editor

The Veeva eConsent editor allows you to transform source documents, such as Microsoft Word informed consent forms (ICFs), into electronic consent (eConsent) forms that participants can review and complete in MyVeeva for Patients. You can also edit and format eConsent forms that you uploaded to Vault directly as Microsoft Word documents.

For sponsors, Veeva eConsent is available if you license and configure it. For sites, Veeva eConsent is available if a sponsor invites you to a connected study or independently if enabled on a study that is not connected.

The following steps outline the most common workflow for creating an eConsent form using the Veeva eConsent editor:

  1. Access the blank ICF that you want to edit in your vault. The blank ICF must be a new ICF that isn’t in a steady state or a new draft version of an ICF. Additionally, the blank ICF can’t be checked out by another user. See the following pages for more information:
  2. Open the eConsent form from the All Actions menu (). The blank ICF is checked out, and the Veeva eConsent editor opens in a new tab.
  3. Prepare and import the Word Document into the eConsent editor. Ensure that the content was uploaded as expected.
  4. Modify the document to set the settings and add sections and blocks, such as the signature block, as needed.
  5. Check in the document.
  6. Send the document to sites.

Browser and Device Prerequisites

To have the best experience using the Veeva eConsent editor, ensure that your browser and device meet the following requirements:

  • Browser: We recommend that you use a desktop browser for the editor, and you’ll have the best experience in Google Chrome, Microsoft Edge, or Mozilla Firefox.
  • Pop-Up Blockers: If you use Apple Safari or Mozilla Firefox to edit an eConsent form, you must configure your browser to allow pop-ups from the Vault website.
  • Resolution: If your screen is smaller than 960 pixels wide or you zoom in to an equivalent width, you may not be able to use some functionality such as the table of contents and the buttons for saving to Vault or checking in.

Best Practices for eConsent Forms

To simplify the editing process and ensure that the participant has a good user experience in MyVeeva for Patients, we recommend that you consider the following items when editing a document in the Veeva eConsent editor:

Topic Description
Microsoft Word Support
  • Import Document: If you are using a Microsoft Word document to collaboratively author your ICF, you can import it into Vault as an eConsent form and the system will automatically transform it.
  • Manage Sections: You must use the Veeva eConsent editor to add and manage eConsent-specific assets like question blocks, signature blocks, images, and videos that aren’t imported when you upload the form into Vault.
  • Review: Use the eConsent editor to review, edit, and check in the version of the document that you intend to approve for use. If you import the version of the Microsoft Word document you intend to approve for use to Vault and approve it without reviewing it, editing it, and checking it in from the eConsent editor, errors occur.
Faster Transformation
  • Import: If you’re using an eConsent form that someone else created, you can import it using an import code or the eForm rendition. See the Importing an eConsent Form page for more information.
  • Copy-and-Paste: You can copy and paste text into content blocks.
  • Split Content: You can also copy and paste an entire document into a text box then select the Split Content icon to break the content into blocks quickly. See the Editing Text Content section on the Working with eConsent Sections and Content Blocks page for more information.
Modular Content
  • Multiple Sections and Content Blocks: Break your ICF into multiple sections and content blocks, for example, a section for the study overview and another for possible risks. Doing so ensures that participants and caregivers view each section, have good user experiences in MyVeeva for Patients, and more easily consume the information.
  • Complex Content in Separate Blocks: If you have longer, more complex content (for example, large tables or specially formatted lists or text), split the content into its own block. This makes it easier to move the content and change its formatting independently of the other content blocks.
See the Adding Sections and Adding Content Blocks sections on the Working With Sections and Content Blocks page for more information.
Simplified Tables We recommend that you keep tables simple on eConsent forms. A complicated table with many columns or tables within tables is difficult for the participant to view on a mobile device or small screen. Additionally, the table may be narrow and difficult to read in the .PDF file of the eConsent form in Vault and MyVeeva for Patients.
Vault Merge Fields Sponsor staff can use Vault merge fields in eConsent forms to eliminate the need to manually edit template eConsent forms for individual sites and countries. You can add Vault merge field tokens to a Microsoft Word-based eConsent form and import it to the editor, or you can add merge field tokens to an eConsent form in the editor. Merge fields are highlighted in preview links for visibility, but when an eConsent form containing merge fields is shared with sites and participants, the correct variable content is displayed as plain text. The following considerations should be made when you use Vault merge fields in an eConsent form:
  • If you update a merge field’s value in Vault, the updated value is not displayed in an eConsent form until you check the form back in to Vault from the editor.
  • The eConsent editor doesn’t support adding multi-value merge fields to tables.
  • If you import a .DOCX file containing merge fields, the tokens are displayed in the editor. If you export a .DOCX file containing merge fields from the editor, the tokens are displayed in the document. If you check in an eConsent form containing merge fields to Vault, the tokens are merged and display their plain text values.
  • Site staff can’t add Vault merge field tokens to eConsent forms.
For more information about Vault merge field tokens, see Using Merge Fields for Microsoft Word & Excel.
Previewing the Document We recommend that you view the web preview from the editor and download the .PDF file to verify that the form is displayed how you expect in both formats. See the Previewing, Downloading, Sending, and Exchanging eConsent Forms page for more information.