Using the Veeva eConsent Editor

Overview of Editing eConsent Forms

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 you’re conducting a study with a sponsor who uses it for a connected study or if you enable it as a paid add-on.

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:
   • Creating, Editing, Previewing, and Approving eConsent Forms in SiteVault
   • Viewing, Editing, Previewing, and Approving eConsent Forms in Study Connect Help
   • Veeva eConsent Authoring (Clinical Operations)
2. Select the action to edit the eConsent form from the Actions menu (Edit eConsent Form in Study Connect). 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.
• 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	We recommend that you use Microsoft Word source documents in the eConsent editor in the following ways: If you're 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. 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. 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	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. 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 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.
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 merge fields display their applicable variable content 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 doesn't reflect 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 display in the editor. If you export a .DOCX file containing merge fields from the editor, the tokens display 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 as you want in both formats. See the Previewing and Downloading eConsent Forms section for more information.

Importing eConsent Forms

You can import eConsent forms into the Veeva eConsent editor using Microsoft Word documents, import codes, or eForm renditions. For example, you can download a Microsoft Word file, review and edit the form with an EC or IRB, then import the new version.

Regardless of which method you use to import your eConsent form or what edits you make in the editor, the original file type of the document in Vault (.PDF or .DOCX) will be maintained throughout the document’s life.

Note: Importing an eConsent form replaces the content you currently have in the Veeva eConsent editor. You can select Undo Changes in the editor if you accidentally replace your edits.

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.
   2. Select the Share icon in the upper-right corner of the participant preview.
   3. Select the 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.
3. Select the 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. All the content in the editor is replaced. You can select Undo Changes in the message at the top of the page if you want to restore the previous 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 Microsoft Word Documents

Complete the following steps to import an eConsent form from a .DOCX file:

1. Ensure that your .DOCX file is formatted per the guidelines below.
2. Select the Import icon in the upper-right corner of the editor.
3. Select Import Microsoft Word (.DOCX).
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. Select Import Document. All the content in the editor is replaced. You can select Undo Changes in the message at the top of the page if you want to restore the previous 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.

Import Guidelines

When you import a .DOCX file, format the file per the following guidelines to ensure that the document is imported correctly:

Guideline	Description
Headings	Use the standard Microsoft Word styles for heading level one and two. Use heading 1 for sections and heading 2 for content blocks. When you download an eConsent form, the system also makes sections heading 1 and content blocks heading 2 in the downloaded .DOCX file.
Images	Don't use text boxes to alter images, and ensure that the images are in a .JPG, .PNG, or .GIF format. The system will import the images.
Lists	Use bullet points or numbered lists in Microsoft Word. Lists that don't use that formatting are not imported as lists.
Tables	Keep bullet points on tables to a minimum. These lists make table rows expand. Additionally, tables on eConsent forms are in portrait format. If you include landscape tables, the system reformats them.
Tracked Changes	Accept or reject tracked changes before importing a file. When you import a .DOCX file with tracked changes, the changes are imported as text.
Videos	If your eConsent form includes videos, add them in the editor after importing the .DOCX file. The first time you import a .DOCX file that includes a video, the system imports the first frame of the video as an image. You can replace the image with the video in the editor. If you download an eConsent form that includes a video then import it later, the video is imported.

Other Formatting and Content

Formatting or Content	Description
Content Blocks	Signature and question blocks need to be created in the Veeva eConsent editor. When you initially import a .DOCX file, use the editor to create signature and question blocks instead of using text blocks for those items. When you download a Microsoft Word document, we use special formatting around the signature and question blocks to ensure they can be imported as the correct content block type.
Fonts	eConsent forms use a sans-serif font. If you import a document that uses a serif font, the system changes it to sans-serif. Font colors and highlights are imported.
Headers and Footers	The system doesn't import headers, footers, or footnotes. The system automatically adds a header and footer to .PDF and .DOCX files. If you edit the header and footer of a .DOCX file in Microsoft Word, the system overwrites your changes when you import the file to the editor.
Margins	Margins are ignored by the import process.
Orientation	Pages on eConsent forms are oriented in portrait mode. The system reformats landscape pages to portrait.
Unsupported Items	The following items can't be imported: <>Columns: The content will be imported into a single column, top to bottom. Comments: While documents with Microsoft Word comments are supported in Vault, the Veeva eConsent editor doesn't support them and will permanently remove comments from imported documents. Cross-reference links within the document Embedded objects such as Microsoft Excel or Microsoft PowerPoint content Fields Images with links Microsoft Word art, shapes, and drawings Page breaks Text boxes. Text will be imported, but any style or placement on a page will not.

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.

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.
3. Select the 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. All the content in the editor is replaced. You can select Undo Changes in the message at the top of the page if you want to restore the previous 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.

Consent Form Settings

Titling eConsent Forms

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.

Locking or Unlocking Site Editing Permissions

When you restrict editing permissions at the document level, the site can still see all sections of the form, but they are unable to change anything.To restrict sites from editing all sections and blocks in the form, select the Lock All button. To allow sites to edit content in the form that is not restricted at the section or block level, select the Allow Edits button.

Requiring an Unlock Code to Sign

If you want to require participants to have a site-provided unlock code to sign the eConsent form, select Settings and toggle the Requires Unlock Code to Sign setting to on.

When site staff send an eConsent form that requires an unlock code to a participant, the participant can review the form before an in-person or virtual consenting visit but can’t sign it until the site coordinator gives them the unlock code. This allows the site to ensure that the participant discusses the form and study with site staff before signing. Site staff create the code in the preview opened from SiteVault.

See the following help topics for more information about how to create the code:

• Locking and Unlocking eConsent Forms in SiteVault eReg Help
• Locking and Unlocking eConsent Forms in Study Connect Help

Requiring a Hand-Drawn Signature

If you want to require MyVeeva users to draw their signature instead of clicking or tapping to sign, select Settings and toggle the Requires Hand-Drawn Signature setting to on.

The following conditions apply to hand-drawn signatures:

• All Users: If hand-drawn signatures are required, MyVeeva users need to draw their signature to sign the eConsent form and won’t need to verify their identity with a code.
• Registered Users: When hand-drawn signatures aren’t required, registered MyVeeva users can choose whether they draw their signature or click or tap to sign.
• Unregistered Users: Hand-drawn signatures are always required if a MyVeeva user is signing a consent form in person without an account registered with a phone number and email address.

Adding or Editing the Header and Footer

Adding a header and footer can help people identify printed documents and keep them in order.

1. Select Settings, and select Edit Header or Edit Footer.
2. Update the column boxes to include the information that you want to be displayed.
3. If you want to add a page count to the footer, enter [[curr_page_num]] where you want the current page number to be displayed, and enter [[total_page_nums]] where you want the total page count to be displayed. You can add any text you want around the number values or translate it for different languages. See the following examples:
   • Example 1: If you enter Page [[curr_page_num]]/[[total_page_nums]], the page count is displayed as Page 1/15.
   • Example 2: If you enter Page [[curr_page_num]] out of [[total_page_nums]], the page count is displayed as Page 1 out of 15.
4. To allow the site to edit the text, turn on the Allow Site Edits toggle.
5. Select Save. The text is saved.

Connecting a Form

If you’re editing a consent form in SiteVault that was shared from a sponsor with Site Connect, a banner is displayed at the top of the editor to notify you that the form is connected to the sponsor. When a MyVeeva user submits a connected consent form, de-identified question and signature response data is sent to the sponsor in Clinical Vault as well as the site in SiteVault.

A green link icon is also displayed next to the question and signature blocks that were in the sponsor’s consent form.

See the following help topics for more information about viewing and reporting on signature and question responses in SiteVault:

• Viewing and Reporting on eConsent Form Responses in SiteVault eReg Help
• Viewing and Reporting on eConsent Form Responses in Study Connect Help

See Reporting Overview for more information about viewing and reporting on signature and question responses in Vault.

Requiring a Signing Order

Signing order represents the order in which consent forms should be completed. For example, when a participant receives two forms with signing order values of 1 and 2, they must complete the form with a signing order value of 1 before the form with a signing order value of 2. Additionally, the following parameters apply to signing order:

• You can apply the same signing order value to multiple forms.
• The signing order value must be greater than 0 and less than or equal to 1000. You can enter up to four decimal places, which can be useful if you add a new document between two existing ordered forms.
• You can leave the signing order value blank if the form doesn’t have to be completed in a certain order.

Complete the following steps to apply a signing order to an eConsent form:

1. Select Settings on the right-hand side of the editor.
2. In the Signing Order field, enter a value.

Working With Sections and Content Blocks

The table of contents on the 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

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

Moving Sections and Content Blocks

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 or Move Down One 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

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.

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

Adding Sections

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.

Restricting Section Editing Permissions

When you restrict editing permissions at the section level, the site can still see all sections of the form, but they are unable to change any content in the restricted section. To restrict sites from editing all content in a section, deselect the Allow Site Edits toggle button beside the section title. To allow sites to edit form content that is not restricted at the block level, select the Allow Edits button.

Adding Content Blocks

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 places for signatures and optional text content above them. You can add one signature block per role that might need to sign a consent form. The site approver signs in SiteVault after all the included roles sign in MyVeeva for Patients. If necessary, you can make an eConsent form template accommodate study countries that require wet-ink signatures by adding a Site signature block to the form. See the Content Block Settings section for more information about the roles.
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. If you want to specify who is able to answer the question, you can select a specific role for the question block. 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
Role	Question, Signature	Select the role for the signature block from the Role list. The following role options are available for question and signature blocks: Participant Site (Signature Block Only) Witness Translator Guardian/Representative Caregiver Proxy If a question applies to all reviewers, leave Default as the selected Role option in the question block. You can only add one signature block per role, but you can add as many role-based question blocks as needed. You can add a signature block for any role that is responsible for signing the consent form. If a role has a signature block in a consent form, an existing reviewer with that role receives the consent form if the site coordinator sends it for that role. Note: When necessary, a document supports signature capabilities for two Guardian role recipients without needing additional document configuration. Wet Ink: To have a single eConsent form accommodate multiple study countries with differing signature regulations, you can add a Site signature block to the form. In study countries that require wet-ink signatures, site staff can print the blank eConsent form and have the participant and signatories sign their applicable signature blocks in wet ink. Site staff can then countersign the Site signature block in wet ink, scan the form, and upload it to SiteVault as an Informed Consent Form (signed) document type. For more information, see Consenting Participants in Wet Ink in SiteVault eReg Help.
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.
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.
Allow Site Edits	Question	Deselect the Allow Site Edits toggle button if you do not want sites to have access to edit the content in the question block. Note: You can also lock content at the document or section level.
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. Questions with more than one response option are required by default, and you can't make questions with only one response required.
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 or Move Down One icon. Remove Responses: You can position your pointer over the response option and select the Remove icon to remove it.
Sponsor Connection Status	Question, Signature	If you're editing a consent form in SiteVault that was shared from a sponsor using Site Connect and is still connected to the sponsor, a green link icon is displayed next to question and signature blocks that were in the sponsor's form. See the Connecting a Form section for more information about connected documents.
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 a consent form is not connected to a sponsor and no text content is present or you remove the name, the system uses a default name such as question_1. For consent forms connected to the sponsor, question, answer, and signature names for connected blocks are filled in automatically with the names that the sponsor defined. You can enter your own name for these blocks, and it won't interfere with the ability to send responses to the connected site. 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, and we recommend not changing the sponsor-defined names when they are present to facilitate communication with the sponsor. See the following help topics for more information about viewing and reporting on signature and question responses: Viewing and Reporting On eConsent Form Responses in SiteVault eReg Help Viewing and Reporting On eConsent Form Responses in Study Connect Help Reporting Overview
Signature, Printed Name, and Date Labels	Signature	You can edit the signature, printed name, and date labels on signature blocks to add custom labels or translations to them. For Site signature blocks, you can edit the site signature placeholder label. Each label has a maximum character limit of 50. By default, the signature, site signature placeholder, printed name, and date labels are in English.

Editing Text Content

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:

Action	Icon	Shortcut	Description
Format		Multiple	You can format text in the following ways: Normal text (CTRL+ALT+0) Quote Code Subheadings 1, 2, and 3 (CTRL+ALT+1,2, or 3) Occasionally, subheading styles may shift to nearby sections of text while you are copying, pasting, or deleting formatted text. If this happens, you can select the Format icon to reapply the correct style to any effected text.
Bold		CTRL+B	Select the Bold icon to bold your text.
Italic		CTRL+I	Select the Italic icon to italicize your text.
Underline		CTRL+U	Select the Underline icon to underline your text.
Strikethrough		Not available	Select the Strikethrough icon to strike through your text.
Bullets		CTRL+SHIFT+8	Select the Bullets icon to add an unordered, or bulleted, list.
Numbers		CTRL+SHIFT+7	Select the Numbers icon to add an ordered, or numbered, list.
Table		Not available	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		CTRL+K	Complete the following steps to add a link: Select the Link icon. Select Insert Link. Enter the web address in the URL box. Enter the link text in the Text box. Select Insert. Note: When adding links to a document, use secure (https://) links instead of unsecure (http://) links. Participants may not be able to access unsecure links from the Android and iOS apps.
Media		Not available	Select the Media icon to add an image or video. See the Working With Media section for more information.
Align		Not available	Select the Align icon then an alignment option to change the alignment of your text.
Clear Formatting		CTRL+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 to paste text without formatting. Then you can apply the formatting you want manually.
Split Content		Not available	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.

Working With Media

You can use images and videos to include helpful visuals on eConsent forms such as device diagrams, visit schedules, and instructions. Videos can be used to further explain study-specific or general medical topics to the participant, for example, the phases of a clinical trial, a summary of informed consent, or an overview of what an MRI entails.

Adding Images and Videos

1. Select the Media icon on the text editor’s toolbar.
2. Either drag-and-drop an image or video in a supported format into the box, or select Browse and select a file. The maximum file size is 2 MB for .JPG, .PNG, and .GIF files and 500 MB for .MP4 files.
3. If you’re adding an image, enter a description in the Description box. This description is used as alternative text for screen readers and accessibility for users in MyVeeva for Patients. See Alternative Text on the WebAIM website for more information about writing high-quality alternative text.
4. If you’re adding an image and want to align it a specific way, select an option in the Alignment section.
5. Select Add Media.

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.

Note: You can’t edit videos. If you want to change an included video, remove it and add a new one.

Removing Images and Videos

• To remove an image, select it and press BACKSPACE (DELETE).
• To remove a video, click to the right of it and press BACKSPACE (DELETE).

Previewing and Downloading eConsent Forms

Previewing eConsent Forms

Select the 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 or from the Blank Forms tab in Study Connect. See the following pages for more information:

• Creating, Editing, Previewing, and Approving eConsent Forms in SiteVault eReg Help
• Viewing, Editing, Previewing, and Approving eConsent Forms in Study Connect Help
• Veeva eConsent Authoring (Clinical Operations)

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

• eConsent Editor: In the editor, select the Download PDF or Download Word Document icon in the upper-right corner.
• eConsent Preview: In the preview opened from Vault, select the ellipsis in the upper-right corner then select Download PDF or Download Word Document.

When you download a Microsoft Word document, we use special formatting around the signature and question blocks to ensure they can be imported as the correct content block type. Only edit the content in the blocks and don’t delete and replace them to ensure they remain the correct type.

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

Autosave

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 Form in Study Connect).

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 media 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 Form in Study Connect).
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.