Editing eConsent Forms

Learn how to edit eConsent forms in the Veeva eConsent editor.

Release Considerations Veeva eConsent is generally available in SiteVault and available to early adopters in Clinical Operations. If you’re interested in becoming an early adopter, contact Veeva support.

Overview of Editing eConsent Forms

Veeva 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 access the editor from SiteVault or Clinical Operations if the Veeva eConsent functionality is configured. The functionality is configured for all sites using SiteVault Free.

Complete the following steps to edit 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. Select the action to edit the eConsent form from the Actions menu (Edit eConsent in SiteVault Free). The blank ICF is checked out, and the Veeva eConsent editor is opened in a new browser tab.
  3. In the new tab, edit the content as necessary. See the Best Practices for eConsent Forms and Using the Veeva eConsent Editor sections for more information.
  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. We also automatically save your progress in the editor every 30 seconds.

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®. Using Microsoft Internet Explorer™ 11 is not recommended, and you may encounter cosmetic issues if you do.
  • 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
Faster Transformation

The following functionality is available to help transform source documents into eConsent forms:

  • Import: If you’re using an eConsent form that someone else created, you can import it using an import code or the eForm rendition. For example, site staff can import an eConsent form from a sponsor or vice versa. See the Importing eConsent Forms section 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 ( Split Content icon ) to break the content into blocks quickly. See the Editing Text Content section for more information.
Modular Content

We recommend that you make your content modular in the following ways:

  • 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 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 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 may be difficult for the participant to view if they're using a mobile device or small screen, as they’ll need to scroll horizontally to view the content. Additionally, the table may be narrowed in the .PDF file of the eConsent form in Vault and MyVeeva for Patients.

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 as you want in both formats.

See the Previewing and Downloading eConsent Forms section for more information.

Importing eConsent forms

Copy Import Code dialog

You can import eConsent forms into the editor in the ways described below. For example, if you’re creating an eConsent form for a site, you can import an eConsent form from a sponsor using an import code then make any site-specific edits to the form in the editor. This allows sites and sponsors to transfer Veeva eConsent forms between vaults without Site Connect.

If you’re a sponsor, we recommend that you use the import codes instead of the eForm renditions to share forms with sites. The import codes are easier to use, are more traceable, and prevent the forms from being edited or formatted incorrectly before they’re imported.

Note Importing an eConsent form replaces the content you currently have in the editor. If you’ve made edits to the content in the editor, we recommend that you save to Vault before you import in case you need to revert the form to its previous version in Vault.

Importing With Import Codes

Importing with a code allows you to import an eConsent form into the editor from your vault or someone else’s using a code copied in the participant preview. To share a code, you can send the person importing the document a link to the participant preview or the import code itself.

Complete the following steps to import an eConsent form using an import code:

  1. If you don’t already have the code or haven’t sent it to the person importing the document, complete the following steps:
    1. Open the participant preview. You can access the link given to you, or you can select the preview option from the Actions menu for the eConsent form in Vault (**Open Preview Link **in SiteVault Free).
    2. Select the Share icon ( Share icon ) in the upper-right corner of the participant preview.
    3. Select the Copy to Clipboard icon ( Copy to Clipboard icon ) to copy the code. We also include instructions in the dialog for how to use the code if you want to share them.
    4. Continue with Step 2 if you’re importing the document, or send the import code to the person importing the document.
  2. In Vault, create a new blank ICF or a new draft of an existing blank ICF, then select the action to edit the eConsent form from the Actions menu (Edit eConsent in SiteVault Free).
  3. Select the Import icon ( Import icon ) in the upper-right corner of the editor.
  4. Select Import With Code.
  5. Paste the import code into the box, then select Import Document. The content in the editor is replaced with your imported content.
  6. Save the document to Vault. We recommend saving a version to Vault before you begin editing, so that you always have a version that represents the original imported content.

Importing eForm Renditions

Complete the steps below to import an eForm rendition (the .JSON file of an eConsent form) into the editor. If you’re creating a copy of a document in your own vault, we recommend that you copy the document in Vault instead. Additionally, if you’re a sponsor sharing a form with sites, we recommend that you use the import codes for ease of use and traceability.

  1. If you don’t already have the .JSON file or haven’t sent it to the recipient, select Veeva eForm from the download options in Vault for the document.
  2. In Vault, create a new blank ICF or a new draft of an existing blank ICF, then select the action to edit the eConsent form from the Actions menu (Edit eConsent in SiteVault Free).
  3. Select the Import icon ( Import icon ) in the upper-right corner of the editor.
  4. Select Import JSON.
  5. Either drag-and-drop the .JSON file into the box or browse for and select it. The maximum file size is 10 MB.
  6. Select Import Document. The content in the editor is replaced with your imported content.
  7. Save the document to Vault. We recommend saving a version to Vault before you begin editing, so that you always have a version that represents the original imported content.

Using the Veeva eConsent Editor

Titling eConsent Forms

Participant-Friendly Title box

Complete the following steps to specify a participant-friendly title for a document:

  1. Select the Edit Title link at the top of the form.
  2. Enter your title, for example, Main Informed Consent Form. The title can be up to 150 characters. If your title is too long, consider shortening it to be more understandable for the participant and including the full title in the document’s text.
  3. Click outside of the title box or select a content block on the page.

The participant-friendly title is displayed in MyVeeva for Patients and on the viewable rendition in Vault but is not saved to a field in Vault. If you want to view the participant-friendly title when you select an ICF to send to a participant, add the title to the document’s Description field in Vault.

Working With Sections and Content Blocks

Table of Contents

The table of contents on the right side of the editor displays the sections and content blocks on your form. You can view, move, remove, and add content blocks on the table of contents.

Viewing Sections and Content Blocks

If you want to navigate to a section or content block, select it on the table of contents.

Moving Sections and Content Blocks

If you want to move a section or content block, drag and drop it on the table of contents. You also can position your pointer over the section or content block on the table of contents and select the applicable Move Up One ( Move Up One icon ) or Move Down One ( Move Down One icon ) icon.

If you drag-and-drop a content block to a different section, the content block is added to the bottom of the section.

Removing Sections and Content Blocks

If you want to delete a section or content block, position your pointer over the section or content block on the table of contents and select the Remove icon ( Remove icon ) .

If the section or block currently includes content, select Yes to confirm that you want to remove it.

Adding Sections

Complete the following steps to add a section:

  1. Select the Add Section icon (+) next to Sections on the table of contents. The section is added to the bottom of the table of contents.
  2. If you want to specify a title for the section, enter it in the title box. Section block titles can be up to 100 characters long.

Note The section title box isn’t displayed if the document has only one section. Additionally, Section [#] is used as a default title in both the editor and MyVeeva for Patients if the document includes multiple sections and you don't specify a title.

Adding Content Blocks

Add Content Block dialog

If you’re currently viewing the section to which you want to add a text content block, select Click to Add Content Block below the last content block.

If you want to add a content block to a different section or add a different type of block, complete the following steps:

  1. Select the section to which you want to add the content block.
  2. Select the Add Content Block icon (+) next to Content Blocks on the table of contents.
  3. Select the type of content block that you want to add. See the Content Block Types section below for more information.
  4. If you want to specify a title for the content block, enter it in the title box. Content block titles can be up to 100 characters long.
  5. Select any additional settings as needed. See the Content Block Types and Content Block Settings sections below for more information.

Content Block Types

The following content block types are available:

Type Description
Text Block If you want to navigate to a section or content block, select it on the table of contents. See the Editing Text Content section for more information.
Signature Block

The signature content block allows you to add a signature and optional text content above it.

Currently, only the participant can sign the form and you can add only one signature block. The site approver signs in SiteVault after the participant signs the form in MyVeeva for Patients.

Question Block The question content block allows you to insert a question and its response options. You can also add text content above the response options. See the Content Block Settings section for more information about how to add responses.

Content Block Settings

The following content block settings are available:

Setting Types Description
Show Text Content Question, Signature

Deselect the Show Text Content checkbox if you want to hide the block's text content. If you do so, the text content you entered is still saved but is not displayed in MyVeeva for Patients or the .PDF files.

You can reselect the checkbox to display the content. The checkbox is selected by default when you add a question or signature block.

Show Title All

Deselect the Show Title checkbox if you want to hide a content block's title. The checkbox is selected by default when you add a content block.

If you hide the title or don't enter one at all, no heading for the block is displayed in MyVeeva for Patients or the .PDF files. Instead, the content block is added to the previous content block or section.

Required Response Question Toggle Required Response to on if you want participants to be required to answer a question before they can sign and submit the eConsent form. This is defaulted to off and can be set only if the question has two or more options.
Responses Question

You can modify a question block’s responses in the following ways:

  • Add Response: Select Add Option and enter your response option in the Your Option box. You can add up to 12 response options.
  • Move Responses: You can drag and drop response options to move them on the list or select the Move Up One ( Move Up One icon ) or Move Down One ( Move Down One icon ) icon.
  • Remove Responses: You can position your pointer over the response option and select the Remove icon ( Remove icon ) to remove it.
Signature Name, Question Name, and Answer Name Question, Signature

The signature, question, and answer names are displayed in the response records for participants and used in Vault reporting. You can either enter a name of up to 128 characters or use the default. The system uses the first 40 characters of the body text as the default name if text is present.

If no text content is present or you remove the name, the system uses a default name such as question_1. The names are displayed in Vault. You can use the names to aggregate response data across separate documents and studies when you create reports. We recommend that you use unique names in a data set for easy organization and reporting.

See the Viewing Form Responses page in SiteVault Help for more information on viewing and reporting on participant responses in SiteVault.

Release Considerations Response reporting is currently available only in SiteVault.

Editing Text Content

Text block

The text formatting toolbar is displayed when you click into or select text in a text content box. The following functionality is available on the toolbar:

Note Similar to other text editors, browsers undo your edits to the current field then continue to the most recent fields you edited when you press CTRL+Z (⌘+Z) in the editor. If you undo edits to one section or content block, make sure you don't undo changes elsewhere on the page also.

Action Icon Shortcut Description
Split Content Split Content icon N/A

Select the Split Content icon to split the text into a new text content block. This enables you to paste an entire document or a large portion of a document into the editor then select where you want to split it into a new content block, which can be quicker than copying and pasting each section from a source document.

The content is split after the cursor. If you want part of the text to be the title of the new text content block, select the text then the Split Content icon. The selected text is made the heading of the new content block, and the content after the selected text is the text content.

Format Format icon Multiple

You can format text in the following ways:

  • Normal text (CTRL+ALT+0 or ⌘+ALT+0)
  • Quote
  • Code
  • Subheadings 1, 2, and 3 (CTRL+ALT+1,2, or 3 or ⌘+ALT+1, 2, or 3)
Bold Bold icon CTRL +B (⌘+B) Select the Bold icon to bold your text.
Italic Italic icon CTRL+I (⌘+I) Select the Italic icon to bold your text.
Underline Underline icon CTRL+U (⌘+U) Select the Underline icon to bold your text.
Strikethrough Strikethrough icon N/A Select the Strikethrough icon to strike through your text.
Bullets Bullets icon CTRL+SHIFT+8 (⌘+SHIFT+8) Select the Bullets icon to add a bulleted list.
Numbers Numbers icon CTRL+SHIFT+7 (⌘+SHIFT+7) Select the Numbers icon to add a numbered list.
Table Table icon N/A

Select the Table icon then Insert Table to add a table. If you want to add or remove rows or columns or add a heading row, select the Table icon then the applicable option.

You can also remove tables by selecting the Table icon then Delete Table.

Link Link icon CTRL+K (⌘+K)

Complete the following steps to add a link:

  1. Select the Link icon.
  2. Select Insert Link.
  3. Enter the web address in the URL box.
  4. Enter the link text in the Text box.
  5. Select Insert.
Image Image icon N/A Select the Image icon to add an image. See the Working With Images section for more information.
Align Align icon N/A Select the Align icon then an alignment option to change the alignment of your text.
Clear Formatting Clear Formatting icon CTRL+SHIFT+M (⌘+SHIFT+M)

Select the Clear Formatting icon to clear the formatting from the text. If you select text first, the selected text’s formatting is removed. If you select the icon without text selected, all the text content formatting in the block is removed.

Note If you’re having issues with formatting, you can press CTRL+SHIFT+V (⌘+SHIFT+V) to paste text without formatting then apply the formatting you want manually.

Working With Images

Add Image dialog

Adding Images

Complete the steps below to add an image. You can use images to include device diagrams, visit schedules, and other helpful visuals on eConsent forms.

  1. Select the Image icon ( Image icon ) on the text editor’s toolbar.
  2. Either drag-and-drop an image into the box or browse for and select an image. The maximum file size is 2 MB, and you can use .JPG, .PNG, and .GIF files.
  3. Enter a description in the Image Description box. This description is used as alternative text for screen readers and accessibility for participants in MyVeeva for Patients. See Alternative Text on the WebAIM℠ website for more information about writing high-quality alternative text.
  4. If you want to align the image a specific way, select an option in the Alignment section.
  5. Select Add Image.

Editing Images

Complete the following steps to change, realign, or edit the description of an image:

  1. Select the image, then select Edit in the upper-right corner of the image.
  2. Make any updates as necessary.
  3. Select Update.

Removing Images

If you want to remove an image, select it and press BACKSPACE (DELETE).

Previewing and Downloading eConsent Forms

Editor Preview mode

Previewing eConsent Forms

Select the Web Preview icon ( Web Preview icon ) in the upper-right corner of the eConsent editor to preview how the eConsent form will be displayed to participants in MyVeeva for Patients. We recommend previewing the document to ensure that the form is displayed as you want.

This preview is viewable to only you as the logged-in user. If you want to create and share a preview of the form with external readers, select the option from the Actions menu in Vault (Open Preview Link in SiteVault Free). See the following pages for more information:

Note The web preview accessed from the editor includes your current content in the editor at the time you open it. It doesn't include more recent edits if you refresh it. If you want to open a new preview, reselect the Web Preview icon.

Downloading eConsent Forms

Select the Download PDF icon ( Download PDF icon ) in the upper-right corner of the eConsent editor to download a copy of the document as a .PDF file. We recommend downloading the .PDF file to ensure that the content is displayed as you want it to be in .PDF format

The participant can download the .PDF file from MyVeeva for Patients, and the file is stored as a viewable rendition in Vault. You can also download the .PDF document in Vault after you save the document or check it in.

Note If you notice that a section or page is separated from its content by a page break in the .PDF document, you can add lines at the end of an earlier block to force a page break in the .PDF document.

Saving and Checking In eConsent Forms

Saving to Vault dialog

Autosave

Autosave indicator

We save your changes automatically in the Veeva eConsent editor every 30 seconds. This occurs after you add text to a content block and click outside of it or after you otherwise edit, add, move, or remove items. You need to save to Vault only if you want to create a new version or share your draft in Vault.

If you leave or close the editor, you can return to it by reselecting the action to edit the eConsent form from the Actions menu (Edit eConsent in SiteVault Free).

Saving to Vault

If you want to save your changes and create a new version in Vault without ending your editing session, complete the steps below. Saving to Vault allows other staff to view the progress you’ve made. If another user needs to edit the form, you’ll need to check in the document from the editor instead.

  1. Select Save to Vault.
  2. If you want to include version comments, enter them in the Version Comments box.
  3. Select Save to Vault. A message is displayed over the Save to Vault and Check In buttons that indicates that your changes are being saved.

When the changes are successfully saved, the message is updated. You can select the linked version number to return to Vault, or you can select the X to close the notification.

Checking In to Vault

When you’re ready to check in your document, complete the steps below. When you check in the document, a new version is created, your editing session is ended, and the document is unlocked in Vault so others can edit it or it can be sent for review. Only one user can edit a document in the editor at a time.

  1. Select Check In.
  2. If you want to include version comments, enter them in the Version Comments box.
  3. Select Check In. When the check-in is complete, we redirect you to the new document version in Vault.

Troubleshooting the Veeva eConsent Editor

You may encounter the following issues while using the Veeva eConsent Editor:

Issue Resolution
HTML was removed from my content.

If you copied and pasted content into the editor and a message was displayed that HTML was removed, your content contained HTML that the editor doesn’t support. Extra characters from the removed HTML may still be present, so check the content you pasted to verify that it’s still correct.

The editor does not support the following items, and any HTML that contains them is removed:

  • Alerts
  • Cross-site scripting
  • External resources
  • Inline frames
  • Pasted images
  • Scripts

The following anchor tags may still be included in your content after the unsupported HTML was removed:

  • href
  • id
  • target
  • title

If you can see HTML tags in the editor, the participant will see them as well. For this reason, we recommend pasting in only rendered HTML and not raw HTML, as the raw HTML will still include the tags in the editor.

My document checkout was canceled.

If you were editing, saving, or checking in the document and a message was displayed that your checkout was canceled, you or an administrative user canceled your checkout in Vault.

Return to Vault to view the current version of the document and, if necessary, reenter the editor.

My editor login expired.

Your access to the editor is determined by whether you’re logged in to Vault. You remain logged in as long as you’re interacting with either Vault or the editor.

If you’re inactive in both Vault and the editor, we log you out of the editor. However, we autosave your content in the editor every 30 seconds. If you’re logged out, simply log in to Vault and reselect the action to edit the eConsent form from the Actions menu (Edit eConsent in SiteVault Free).

I can’t save to Vault or check in the document.

Follow the instructions in the error message displayed in the application. You won’t be able to save or check in the document if you’re logged out or if either Vault or the Veeva eConsent editor is experiencing issues. Try again later and contact Veeva support if the issue continues.