Set Up Follow-Up Online Questionnaires

Configure Vaults to automatically generate and send online questionnaires to Case Contacts for follow-up information.

About Scheduled Follow-Up Emails

This page provides instructions on how you can configure your Vault to generate and send online questionnaires to Case Contacts for follow-up information. Follow-up questionnaires are used when there is missing information on the Case. For instructions on how to use this feature once configured, see Send a Follow-Up Online Questionnaire to Case Contacts.

Vault generates a Questionnaire Transmission record to log events regarding the email and sends the questionnaire to the Case Contact’s designated email address if the following are met:

• A Case matches the criteria defined in a Follow-up Questionnaire Rule or Watchlist.
• The Case Contact provides both their email address and consent.
• You have configured the Vault to automatically send questionnaires to recipients when the Case meets the Follow-up Questionnaire Rule criteria.

Prerequisites

Consider the following requirements before you can configure follow-up questionnaires:

• Enable online questionnaires for post-marketing follow-ups. This questionnaire setup leverages Vault Checklist functionality.
• Before you can add questionnaire templates for Watchlists and Adverse Events of Special Interest (AESI), you must have already configured the Watchlist.

Important Terms

Before you start configuring follow-up questionnaires, it’s important to understand the following terms:

• Case Contact: The person reporting the adverse event. This may be a medical professional or the patient themselves. This information is stored using a Case Contact record.
• Email Consent: The Case Contact has explicitly provided consent to be contacted about this Case by email.
• Questionnaire: A predefined form with questions and requests for information to be sent to a Case Contact.
• Watchlist: A specific set of MedDRA terms of special interest for a specific product. This is sometimes referred to as Adverse Events of Special Interest (AESI).

Best Practices & Recommendations

For details, see Set Up Scheduled Follow-Up Questionnaire Emails.

Create the Questionnaire Template Document

For details, see Set Up Scheduled Follow-Up Questionnaire Emails and the template document fields.

Add Reply-To Contact Emails

For details, see Set Up Scheduled Follow-Up Questionnaire Emails.

Configure Follow-Up Online Questionnaires

When a Case requires follow-up information, Vault matches Cases with questionnaires to obtain the necessary information. Configure online Case questionnaires using the steps below:

1. Create a Questionnaire Checklist Design.
2. Create Question Designs.
3. Create Question Field Mappings.
4. Create Follow-Up Questionnaire Rules.

Create Questionnaire Checklist Designs

This setup leverages Vault Checklist functionality. Using the Visual Checklist Designer provides more information on creating sections, designing a question section, and adding library questions.

To create Questionnaire Checklist Designs:

1. Go to Business Admin > Objects > Checklist Designs.
2. Select Create.
   A Create Checklist Design window appears.
3. Select the Questionnaire Checklist Design object type and then Continue.
4. On the Create Questionnaire Checklist Design page, complete the following information:
   • Checklist Name: Enter a name for this questionnaire checklist design.
   • Checklist Type: Select a checklist type from the dropdown menu. You may need to first create a checklist type. For more information about selecting and creating checklist types, see Configuring Checklists.
     For weighting and translation resources, see Vault’s Checklist Scoring & Weighting and Translating Checklist Designs.
5. Select Save.
6. On the questionnaire, you can add sections in the left panel.
7. Add questions to the questionnaire checklist design or see the section below to create Question Designs.

After You Finish

After creating a Questionnaire Checklist Design, you can select the View Record Detail Page icon () to set fields and add the following records:

• Follow-up Questionnaire Rules
• Watchlists
• Countries
• Checklist Design Translations
• Question Field Mappings
• Section Designs
• Questions

Alternatively, see the sections below for instructions on adding them in Business Admin.

(Optional) Enable Ad Hoc Questions and Sections

If enabled, respondents can add ad hoc questions and sections to checklist instances. You must grant permissions and follow the steps below to set the relevant fields:

1. In the respective Questionnaire Checklist Design, select Edit.
2. In the Details section, set the following fields to Yes:
   • Ad Hoc Questions Allowed
   • Ad Hoc Sections Allowed
3. Select Save.

(Optional) Add Watchlist Design Records

For details on configuring watchlists in your Vault, see Configure Adverse Event Watchlists.

To add a Watchlist record to a Questionnaire Checklist Design:

1. In the respective Questionnaire Checklist Design, expand the Watchlist section.
2. Select Add.
   A Search: Watchlist window appears.
3. In the window, select or create the applicable watchlists. You can also use the search bar and filters to refine your search.
4. Select OK.

Watchlist records in a Questionnaire Checklist Design help Vault determine whether to send an online questionnaire to the Case Contacts. For more information, see How Vault Determines When to Send an Online Questionnaire.

(Optional) Add Country Design Records

For details on configuring countries in your Vault, see Managing Countries.

To add a Country record to a Questionnaire Checklist Design:

1. In the respective Questionnaire Checklist Design, expand the Country section.
2. Select Add.
   A Search: Country window appears.
3. In the window, select or create the applicable countries. You can also use the search bar and filters to refine your search.
4. Select OK.

Country records in a Questionnaire Checklist Design help Vault determine whether to send an online questionnaire to the Case Contacts. For more information, see How Vault Determines When to Send an Online Questionnaire.

Create Question Designs

A Question Design is a question associated with a section on a Questionnaire Checklist Design.

To create Question Designs:

1. Go to Business Admin > Object > Question Designs.
2. Select Create.
   A Create Question Design window appears.
3. Select a question type from the dropdown menu and then Continue.
4. Complete the information on the [Question Type] page. The fields on this page vary depending on the question type selected. See Vault’s Checklist Question & Answer Setup for field information while noting the following differences:
   • Section Design: Select the Questionnaire Checklist Design and section.
   • Documents Allowed: Vault automatically selects No. Always leave the default selection since online questionnaires are sent using a public access link (PAL), which does not support document attachments.
   • Documents Required: Vault automatically selects Not Required. Leave the default selection.
5. Select Save.

Create Question Field Mappings

Setting up question field mappings allows Vault to pre-populate questionnaire answers and reduces recipient effort. Vault copies the respective field’s source value from the Case to the questionnaire response.

Vault can pre-populate fields of the following objects:

• Case
• (Primary) Case Adverse Event
• (Primary) Case Product
• Case Contact

To create question field mappings:

1. Go to Business Admin > Objects > Question Field Mappings.
2. Select Create.
3. On the Create Question Field Mapping page, complete the following information:
   • Object Name: Enter the API name of the object
   • Field Name: Enter the API name of the field.
   • Question Design: Select the Question Design from the dropdown menu.
   • Questionnaire Design: Select the Questionnaire Checklist Design from the dropdown menu.
4. Select Save.

Create Follow-Up Questionnaire Rules

When Vault generates Correspondences and questionnaires for a Case, it uses Follow-up Questionnaire Rules to match questionnaires to the Case.

To create Follow-up Questionnaire Rules:

1. Go to Business Admin > Objects > Follow-up Questionnaire Rules.
2. Select Create.
3. On the Create Follow-up Questionnaire Rule page, complete the following information:
   • Name: Enter a name for the Follow-up Questionnaire Rule.
   • Days Between Attempts: The number of days that should pass between each email attempt to the Case Contact. You can specify up to 30 days.
   • Enable Auto-Send: Select this checkbox to allow Vault to automatically send online questionnaires to the desired Case Contacts once this Follow-up Questionnaire Rule is met.
   • From: Select a From email address from the picklist. You may first need to configure From email addresses.
   • Reply-To: Select a Reply-To email address from the picklist. After this questionnaire is sent to a Case Contact, this is the person the Case Contact is replying to.
   • Total Attempts: The total number of attempts that Vault should make to email the Case Contact. After the first email, Vault waits the specified Days Between Attempts before sending the next email, and each one thereafter. You can specify up to 10 attempts.
4. Select Save.

Add Follow-Up Rule Criteria

Set up Follow-up Questionnaire Rule criteria the Case must satisfy to meet this rule and match a questionnaire:

1. In the Follow-up Questionnaire Rule, go to the Follow-up Rule Criteria section.
2. Select Create.
3. On the Create Follow-up Rule Criteria page, complete the following information:
   • Object Name: Enter the API name of the object.
   • Field Name: Enter the API name of the field.
   • Value: Enter the field’s source value.
4. Select Save.
5. Repeat the above steps to add more criteria.

Add Questionnaire Checklist Designs

Once a Case satisfies the Follow-up Questionnaire Rule criteria, Vault matches it with a questionnaire. Link the Questionnaire Checklist Designs to the Follow-up Questionnaire Rule:

1. In the Follow-up Questionnaire Rule, go to the Questionnaire Designs section.
2. Select Add.
   A Search: Checklist Design window appears.
3. In the window, select all applicable checklist designs to link them to the Follow-up Questionnaire Rule, or select Create to create new checklist designs.
4. Select OK.

How Vault Determines When to Send an Online Questionnaire

You can configure an entry action or user action to trigger questionnaire generation. The following flowchart illustrates how Vault determines whether to generate the Questionnaire record and email questionnaires for a given Case:

1. When triggered by an entry action or user action, Vault looks at the criteria of the Follow-up Questionnaire Rules. Vault selects the Follow-up Questionnaire Rule when:
   • The Case meets all the criteria.
   • There are no criteria in the rule.
     When triggered by a user action, the user must also confirm Vault’s rule selection.
2. For each selected Follow-up Questionnaire Rule, Vault selects the Questionnaire Checklist Designs that meet the following:
   • Does not contain any Watchlist Design records or contains Watchlist Design records that match the Case Watchlist Tags.
   • Does not contain any Country Design records or contains Country Design records that match the Case Contact Country or, if blank, the primary Event Country.
3. Vault looks at the Case Contacts who have provided an email address and consent.
4. For each Case Contact and Follow-up Questionnaire Rule pair, Vault generates a Questionnaire record and links the questionnaires for the respective rule in the record.
5. Vault verifies which of the selected Follow-up Questionnaire Rules have enabled the Enable Auto-Send checkbox. For these rules, Vault automatically emails the questionnaires to the Case Contacts once the rule is met. Each questionnaire can be accessed using a public access link (PAL).

Watchlist and AESI Questionnaires

For details on configuring Watchlist and AESI questionnaires, see Set Up Scheduled Follow-Up Questionnaire Emails.