Set Up Follow-Up Questionnaires

Configure your Vault so that users can run the Create Correspondence and Questionnaires action to generate and send questionnaires for Cases that require follow-up. Vault uses Follow-up Questionnaire Rules to determine the criteria with which to match questionnaires. When the action runs, Vault evaluates the Case against the selected Follow-up Questionnaire Rules as well as any Watchlists. Vault then generates a Questionnaire type of Transmission for each matching Follow-up Questionnaire Rule and Case Contact pair when the following conditions are met:

  • A Case matches the criteria defined in a Follow-up Questionnaire Rule or Watchlist.
  • The Case Contact includes both an email address and consent.

Vault generates the following types of follow-up questionnaires:

  • Online Questionnaires: Vault generates online questionnaires leveraging checklists and sends recipients a link to enter follow-up data. Users can review and modify the questionnaires before sending them to recipients.
  • Questionnaire Documents: Vault generates questionnaire documents from templates, which can be automatically or manually sent as email attachments. Users can modify the documents before sending them to recipients.

For instructions on how to use this feature, see Send a Follow-Up Questionnaire to Case Contacts.

Online Questionnaires

Users can generate checklists for online questionnaires, then review and update the checklists before sending them to recipients to collect follow-up information. Vault sends recipients a public access link (PAL), allowing them to securely respond without logging into a Vault and without the ability to view or access any areas of your Vault.

How Vault Determines When to Send an Online Questionnaire

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

Follow-up Online Questionnaire Process Flow

  1. 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 for email correspondence, Vault selects the Questionnaire Checklist Designs that meet the following:
    • Does not contain any Watchlist Designs or contains Watchlist Designs that match the Case Watchlist tags.
    • Does not contain any Country Designs or contains Country Designs 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 and links the questionnaires for the respective rule.
  5. Vault verifies which of the selected Follow-up Questionnaire Rules have selected the Enable Auto-Send checkbox. For these rules, Vault automatically emails the questionnaires to the Case Contacts when the rule is met. Each questionnaire can be accessed using a public access link (PAL).

Questionnaire Documents

Users can generate follow-up questionnaire documents based on matching templates, then review the documents before sending them to recipients. The Correspondence Method of the associated Questionnaire type of Transmission determines if users send those documents automatically, through Vault, or manually, outside of your Vault. Vault creates Case > Correspondence > Questionnaire follow-up documents based on the matching document templates when the associated Follow-up Questionnaire Rule meets following criteria:

How Vault Matches Questionnaire Document Templates

Vault matches questionnaire templates based on the Product, Country, and Language values of the template document and Case. For more information, see Set Up Scheduled Follow-Up Questionnaire Emails.

Prerequisites

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

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.
  • Email Consent: The Case Contact has explicitly provided consent to be contacted about this Case by all methods of communication, which is tracked with the Email Consent Provided checkbox of the Case Contact.
  • 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). Vault does not evaluate the Case against MedDRA Terms for questionnaire documents.

Overview

Complete the following procedures to configure Follow-Up Questionnaires in your Vault:

  1. Create Questionnaire (Template) and AESI Questionnaire (Template) types of documents to use as document-based questionnaire templates, considering the best practices & recommendations.
  2. Add reply-to contact emails for applicable Persons.
  3. Optional: Create checklists for online questionnaires.
  4. Create Follow-up Questionnaire Rules to define the criteria Vault uses to generate questionnaires.
  5. Optional: Customize notification templates Vault sends recipients.

Create Checklists

To send online questionnaires, you must configure checklists, which Vault sends to recipients.

Create Questionnaire Checklist Designs

To create Questionnaire Checklist Designs:

  1. Navigate to Business Admin > Objects > Checklist Designs.
  2. Select Create.
  3. Select the Questionnaire Checklist Design object type and then Continue.
  4. On the Create Questionnaire Checklist Design page, complete the following information:
  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 creating a Questionnaire Checklist Design, you can select the View Record Detail Page (View Record Detail Icon) icon to populate fields and add the following records:

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

Alternatively, you can create Question Designs as needed.

Enable Ad Hoc Questions and Sections

You can configure checklists so that users and respondents can add ad hoc questions and sections to checklists. You must grant permissions and update the following fields to Yes on the Questionnaire Checklist Design:

  • Ad Hoc Questions Allowed
  • Ad Hoc Sections Allowed

Add Watchlists and Countries

You can add the applicable Watchlists and Countries to each Questionnaire Checklist Design. These help Vault determine whether to send an online questionnaire to the Case Contacts. To do this:

  1. Navigate to the applicable Questionnaire Checklist Design.
  2. Optional: Add Watchlists:
    1. In the Watchlist section, select Add.
    2. In the window, select or create the applicable Watchlists. You can also use the search bar and filters to refine your search.
    3. Select OK.
  3. Optional: Add Countries:
    1. In the Countries section, select Add.
    2. In the window, select or create the applicable Countries. You can also use the search bar and filters to refine your search.
    3. Select OK.

Create Question Designs

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

  1. Navigate to Business Admin > Object > Question Designs.
  2. Select Create.
  3. Select a question type, 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 Checklist Question & Answer Setup for field information while noting the following differences:
    • Section Design: Select the Questionnaire Checklist Design and section.
    • Documents Allowed: Ensure this value is No.
    • Documents Required: Ensure this value is Not Required.
  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. When Question Field Mappings reuse the same fields and objects, you can set the Standard Question Field Mapping. This allows Vault to map API names of standard fields and their respective objects, instead of requiring manual entry.

Question Field Mapping and Standard Question Field Mappings support the following objects:

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

When creating Question Field Mappings, required fields depend on whether you are selecting a Standard Question Field Mapping. To create Question Field Mappings:

  1. Navigate to Business Admin > Objects > Question Field Mappings.
  2. Select Create.
  3. On the Create Question Field Mapping page, enter the following:
    • Field Name: Enter the API name of the field. If selecting a Standard Question Field Mapping, Vault populates this field upon saving the record.
    • Object Name: Enter the API name of the object. If selecting a Standard Question Field Mapping, Vault populates this field upon saving the record.
    • Questionnaire Design: Select a Questionnaire Checklist Design.
    • Question Design: Select the Question Design.
    • Standard Question Field Mapping: (Optional) Select a Standard Question Field Mapping.
  4. Select Save.

Create Follow-Up Questionnaire Rules

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

  1. Navigate 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.
    • 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 when this Follow-up Questionnaire Rule is met.
    • From: Select an email address. You may first need to configure the email addresses.
    • Reply-To: Select an email address. When this questionnaire is sent to a Case Contact, this is the person the Case Contact replies 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.
    • Generate Document from Template: Select this checkbox to generate questionnaire documents from active templates instead of generating online questionnaires.
    • Distribute Document by Email: If you selected the Generate Document from Template checkbox, select this checkbox to send generated documents as email attachments for automatic Correspondence Methods. If you do not select this checkbox, users must manually send questionnaire documents outside of your Vault.
  4. Select Save.

Add Follow-Up Rule Criteria

Add up to ten Follow-up Rule Criteria to define the criteria a Case must satisfy to match a questionnaire:

  1. Navigate to the applicable Follow-up Questionnaire Rule.
  2. In the Follow-up Rule Criteria section, select Create.
  3. Define the criteria Vault uses to evaluate Case data for the associated Follow-up Questionnaire Rule using either of the following options:
    • To define complex criteria, in the Follow-up Rule Criteria Query Builder field, enter a formula expression that returns as true.
      • Optional: Use the Check Syntax button to validate your query.
    • To define simple criteria, enter values in the following fields:
      • Object Name: Enter the API name of the Case (case_version__v) or Case child object.
      • Field Name: Enter the API name of the field on the specified object.
      • Value: Enter the applicable value of the specified field.
  4. Select Save.
  5. Repeat the above steps to add more criteria. For simple criteria, you can create one Follow-up Rule Criteria for each Object Name and Field Name combination.

Follow-Up Rule Criteria Query Builder

When building a query using VQL formula expressions, you can use any of the operators and functions in the Vault Formula Reference Guide and the Safety-specific functions detailed in Create Formula Expressions.

Example

The following example returns true for serious, post-marketing Cases:

IF( AND(case_version__v.serious__v=TRUE, OR( AND(case_version__v.report_type__vr.api_name__v= "study__v",case_version__v.study_product_reason__vr.api_name__v!= "clinical_trial__v"), OR( case_version__v.report_type__vr.api_name__v="spontaneous__v", case_version__v.report_type__vr.api_name__v="literature__v", case_version__v.report_type__vr.api_name__v="literature_study__v"))), TRUE,FALSE)

Add Questionnaire Checklist Designs

When 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. Navigate to the applicable Follow-up Questionnaire Rule.
  2. In the Questionnaire Designs section, Select Add.
  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.

Customize Notification Templates

You can configure the following templates to customize the emails Vault sends for each questionnaire:

  • Online Questionnaire Email
  • Questionnaire Email with Documents

You can use the following object message tokens in the Subject and Email Body fields of the notification, which reference the corresponding fields on the Case:

  • ${Custom.patient_id_value__v}
  • ${Custom.primary_event_reported__v}
  • ${Custom.primary_product_reported__v}
  • ${Custom.receipt_date__v}
  • ${Custom.new_info_date__v}
  • ${Custom.uid__v}
  • ${Custom.worldwide_uid__v}

Translate Email Notifications

You can use the bulk translation tool to add translations for the subject_template and message_template fields of the notification. This enables Vault to send Case Contacts language-specific emails. Vault determines which translation to use based on the Reporter Language value of the Case Contact. Vault uses the base language translation in the following scenarios:

  • The Reporter Language of the Case Contact is blank or not supported
  • The Translated Label column of the bulk translation file is blank