Configure Web Intake Forms

You can configure Web Intake Forms in accordance with your organization’s branding, which respondents can access on desktop and mobile devices for postmarketing data collection such as adverse event reports (AERs). Vault generates a public access link (PAL) for each form, allowing respondents to securely submit data without viewing or accessing any areas of your Vault. When a respondent submits a form, Vault generates an Inbox Item from the submitted data based on Veeva-defined field mappings as well as a Web Intake Form record linking to the Inbox Item.

Vault includes the following access options for Web Intake Forms:

• Single Use forms with time-limited access for occasional respondents. These can be used for spontaneous adverse event reporting. These forms require respondents to complete a CAPTCHA.
• Repeat Use forms that require email verification for frequent respondents. These forms require respondents to verify their email address before they can access a link to the form. Email verification for a particular form lasts for 30 days, after which a respondent will be prompted to verify their email again before completing the form.

Prerequisites

Before you can configure this feature in your Vault, you must complete the following:

• Enable Web Intake Forms
• Configure Case Access Group security
• Optional: We recommend configuring a custom outbound domain for emails Vault sends respondents, including a From Email Person type of Person you can select for Safety Form Admins.

If you’re interested in discussing whether getting early access to this feature is appropriate for your business needs, contact your Veeva Representative.

Create Organizations

You must create the applicable Trusted Vendor types of Organizations that will submit Web Intake Forms.

Define Allowed Email Domain Lists

You must add all email domains to your Vault’s allowed email domain list for all vendors for which you will configure Repeat Use types of Safety Form Admins:

1. Navigate to Business Admin > Objects > Allowed Email Domain Lists.
2. Select Create.
3. Select the applicable Trusted Vendor.
4. Enter the Email Domain of the selected Trusted Vendor. For example, enter veepharm.com.
5. Select Save.

If a respondent attempts to verify their email address with an email address from a domain without an Allowed Email Domain List record, Vault does not send a follow-up email for that respondent to continue with an Web Intake Form.

Each time a respondent verifies their email address for a Repeat Use form, Vault creates or updates a Verified Email ID with details about the associated form and last active session, with associated Verified Email ID Email Events. Vault inactivates Verified Email IDs after 30 days of inactivity.

Form Designs

Form Designs define the page respondents see when they access the form. Veeva provides standard form components that reflect standard questions for collecting AER details and you can create custom records for certain components. Fields and answers map to corresponding Inbox Item sections and fields so that generated Inbox Items include data from submitted forms. Design components include:

• Form Sections: Pages available for data entry on the form, including:
  • Respondent
  • Patient
  • Product
  • Event
  • Additional Information
  • Documents
• Form Fields: Questions available for respondents to answer
• Form Answer Selections: Answers available for the Form Fields
• Section Field Groups: Define which Form Fields display in each section
• Conditional Field Display Rules: Define the display and requiredness conditions for certain Form Fields

Form Fields

Vault provides standard Form Fields for your use in Form Designs. For all mapped picklist fields, Vault only displays active values on forms. You can also create custom records for certain supported field types for fields supported for structured data intake that meet field limits and restrictions. To do this:

1. Navigate to Business Admin > Objects > Form Fields.
2. Select Create.
3. In the Create Form Field dialog, select Custom, and then Continue.
4. Enter a Name for the field.
5. Select the Form Section this field will appear in. You cannot add fields to the Document section.
6. Optional: Enter Field Help Text that displays to respondents on the form.
7. Enter a Field Label that displays to respondents on the form.
8. Select an Answer Type. For all RadioGroup types, you must create at least one Field Answer Selection.
9. Optional: Enter the following details to map a field of the same type you selected for Answer Type:
   • For Mapped Field Name, enter the unique API name of the field. For example, custom_field__c.
   • For Mapped Object Name, enter the API name of the object on which the field exists. For example, case_versiont__v.
   • If you selected Product for the Form Section, you must map to the case_product__v object.
   • If you selected Event for the Form Section, you must map to the case_adverse_event__v object.
   • If you selected Patient, Reporter, or Additional Information for the Form Section, you must map to the case_version__v object.
10. Select Save.

Field Answer Selections

Vault provides standard Field Answer Selections for your use in Form Designs. You can also create up to ten custom records for each RadioGroup type of Form Field. To do this:

1. Navigate to Business Admin > Objects > Field Answer Selections.
2. Select Create.
3. Enter a unique Name for the answer.
4. Select the RadioGroup type of Form Field to which this answer applies.
5. Define the following optional fields, as applicable:
6. Enter a Display Order to specify the order this answer displays under the Form Field. If you leave this field blank, Vault orders the answers by order of creation.
7. Select a Controlled Vocabulary.
8. Select a Reason Omitted.
9. Select Save.

Section Field Groups

Vault provides standard Section Field Groups to define which Form Fields appear in each Form Section. You can also create custom records. To do this:

1. Navigate to Business Admin > Objects > Section Field Group.
2. Select Create.
3. Select the Form Design Version to which this group applies.
4. Select the Form Section in which field appears.
5. Define the following optional fields, as applicable:
   • Select the Form Field to which this group applies.
   • Select the Field Display to specify the display or requiredness condition of the selected Form Field.
   • Enter a Field Display Order to specify the order this field displays in the section. If you leave this field blank, Vault orders the field by order of creation.
   • Enter Field Help Text Override to display instead of the Field Help Text of the selected Form Field.
   • Enter Field Label Override to display instead of the Field Label of the selected Form Field.
6. Select Save.
7. Optional: In the Conditional Field Display Rules section, create rules for this group.

Conditional Field Display Rules

You can create Conditional Field Display Rules to define the display or requiredness conditions for certain Form Fields on Web Intake Forms. You can nest up to three Conditional Field Display Rules. For example:

• Level 1: Field A = Yes
• Level 2: Field B displays based on Field A
• Level 3: Field C is required based on Field B

To create a Conditional Field Display Rule:

1. Navigate to Business Admin > Objects > Conditional Field Display Rules or to the Conditional Field Display Rules section of the applicable Section Field Group.
2. Select Create.
3. Select the Form Design Version to which this rule applies.
4. Select a unique Source Field associated with the specified Form Design Version. The Form Field you select here here must have an Answer Type of Picklist, RadioGroup, YesNo, or CheckboxGroup.
5. Select a Condition to define when the specified Value applies.
6. Enter the exact Value to which the rule applies. To apply to multiple values, separate each value with a comma. Depending on the Answer Type of the specified Target Field and Source Field, the field supports the following values:
   • Picklist: Name of the picklist value
   • RadioGroup: Name of the Field Answer Selection
   • YesNo: Yes and No
   • CheckboxGroup: Name of the Field Answer Selection (this type only applies to the standard Event Seriousness record)
7. Select the Target Field Display to specify the display or requiredness condition of the selected Target Field.
8. Select a unique Target Field associated with the specified Form Design Version.
9. Select Save.

Form Design Versions

Form design versioning allows you to manage changes to Web Intake Forms over time in a controlled manner. With versioned forms, you can track form responses to the specific form design version from which it was created, allowing you to maintain traceability. Run the Create Draft Version action on a Form Design to generate a new Form Design Version. Run the Approve Version action to approve the Form Design and publish the latest version for all associated forms. Any previous versions update to Superseded state. You cannot edit approved Form Designs or their associated records.

Create Form Stylesheets

Use Form Stylesheets to define your branding for Web Intake Forms. Create a Form Stylesheet for each Sponsor type of Organization that will receive forms:

1. Navigate to Business Admin > Objects > Form Stylesheets.
2. Select Create.
3. Enter a Name.
4. Upload a Header Logo PNG, JPG, or JPEG file up to 500 KB that is 176 pixels by 88 pixels in size. This image will appear on all forms associated with this stylesheet. We recommend uploading a dark-colored image in a PNG file.
5. Select a Sponsor type of Organization to which this stylesheet applies.
6. Upload a Privacy Notice PDF file that will be accessible from the Privacy Notice link in the footer of all forms associated with this stylesheet.
7. Enter a Reference Number Prefix up to three alphanumeric characters that Vault will prepend to a generated Case Identifier value for all submitted forms associated with this stylesheet. We recommend using uppercase letters for this prefix.
8. Select Save.

If you update the Header Logo or Privacy Notice after record creation, Vault syncs the updates to all associated forms.

Create Safety Form Admins

Use Safety Form Admins to define how respondents will access the Web Intake Forms associated with the specified Form Stylesheet. Vault generates a URL at which respondents can access the associated form with the following Safety Form Admin parameters:

https://[Vault-DNS]/safety-form/[Access-Type]/[Form-Name-for-URL]

You can integrate the generated URL on your organization’s website for respondent access. Vault uses the following field values in the generated URL, which cannot be modified after the Safety Form Admin is in Published state:

• Vault DNS: The value generated by Vault for the specified Connection
• Access Type: Based on the specified value
  • Single Use: su
  • Repeat Use: ru
• Form Name for URL: The specified value

To create a Safety Form Admin:

1. Navigate to Business Admin > Objects > Safety Form Admins.
2. Select Create.
3. Enter a Name.
4. Select Access Type to specify if the form will be single or repeat use.
   • If you select Repeat Use, create a Form Admin Trusted Vendor.
5. Select the Safety Form type of Connection.
6. Optional: Enter a Description.
7. Enter three characters or more for the Form Name for URL. This field supports numbers, letters, and hyphens (-). This value appears at the end of the URL respondents use to enter forms associated with this record.
8. Optional: Enter an Error Message Description that displays to respondents if Vault encounters an error during form submission.
9. Select the Form Stylesheet to which this record applies.
10. Optional: Enter a From Email for the applicable From Email Person. All emails generated for forms associated with this record include this value as the sender. If you leave this field blank, Vault sends related emails from vault-emails@veeva.com.
11. Select an Organization. This must be the same Organization specified in the associated Form Stylesheet.
    • If you selected Repeat Use for Access Type, ensure you create the applicable Form Admin Trusted Vendors.
12. Optional: Select a Pre-populate Report Type value to assign a specific report type to Inbox Items generated for forms associated with this record.
13. Select a Form Design.
14. Specify if the associated forms Allow Document File Upload. When you select Yes, all associated Form Designs include a Documents section in which respondents can upload and attach files. If you leave this field blank, associated Repeat Use forms include the Document section, but Single Use forms do not.
15. Select Save.
16. On the new record, run the Publish action.

When you run the action, Vault updates the Sync Status value to Pending. When the sync completes:

• The Sync Status updates to Synced.
• Vault populates the Published Date and Published URL field. This is the URL at which respondents can access forms associated with this Safety Form Admin. You can provide this link directly to respondents or integrate it on your organization’s website.
• The record updates to the Published state to indicate when the content is published on the associated Web Intake Forms. You can have up to five Safety Form Admins in the Published state.
• You cannot change the Access Type or Form Name for URL values.

Inactivate Forms

You can move a Safety Form Admin to the Inactive state if you no longer want to use it. When you do this, Vault populates the Inactivation Date for traceability. The Published URL field remains active, but respondents can no longer access associated forms.

Create Form Admin Trusted Vendors

You must associate each Repeat Use type of Safety Form Admin with a Trusted Vendor type of Organization by creating Form Admin Trusted Vendors:

1. Navigate to Business Admin > Objects > Form Admin Trusted Vendors.
2. Select Create.
3. Enter a Name.
4. Select the applicable Repeat Use type of Safety Form Admin.
5. Select the applicable Trusted Vendor.
6. Select Save.

Vault adds the Trusted Vendor to the selected Safety Form Admin. To remove access before 30 days of inactivity, you can manually remove the related record from the Safety Form Admin.

Customize Notification Templates

You can update your Vault’s email banners and customize the following notification templates that Vault sends to form respondents:

• Safety Form Email Verification: Sent to respondents to verify their email address before accessing a Repeat Use form.
• Safety Form Access: Sent to respondents after verifying their email address so they can access a Repeat Use form.
• Completed Safety Form Reference: When requested, sent to respondents after they submit a form.