Working with eConsent Sections and Content Blocks

The signature content block allows you to add places for signatures and optional text content above them. You can add two signature blocks for the witness role, and one signature block for all other roles 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 to 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.

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.

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. Selecting the Default Role option will assign the question to the recipient according to the highest rank as ordered below:

• Proxy
• Guardian/Caregiver
• Participant
• Witness
• Translator

You can only add one signature block for all roles, with the exception of the witness role, which you can add up to two signature blocks for. However, you can also add as many role-based question blocks as you need to.

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.

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 the Collect Consent Signatures in Wet Ink section on the Consenting Participants in Wet Ink page in SiteVault Help.

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 do not 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.

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.

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.

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.

If you’re editing a consent form in SiteVault that was shared by a sponsor 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.

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 will not 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 eConsent Form Responses in SiteVault eReg Help
• Reporting On eConsent Form Responses in Study Connect Help

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.

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.

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.

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.

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.

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.