Set Up Scheduled Follow-Up Questionnaire Emails

Administrators can configure vaults to automatically generate and send email questionnaires to case reporters for follow-up information.

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About Scheduled Follow-Up Emails

This page provides instructions to Administrators to configure their vaults to automatically generate and send questionnaires to case reporters for follow-up information. For instructions on how to use this feature once configured, see Send a Follow-Up Email Questionnaire to a Case Reporter.

You can set up questionnaires using vault’s controlled document management capabilities. To customize the criteria for which a questionnaire is sent, you can configure Follow-Up Rules or leverage Watchlists to monitor Adverse Events of Special Interest (AESI).

If a Case matches with a questionnaire template for a Follow-Up Rule or Watchlist and the reporter provides their email and consent to be contacted, then the system automatically performs the following actions:

  • Generates a Correspondence Transmission record to log events regarding the email
  • Emails the questionnaire to the reporter's designated email address

Prerequisites

Note 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:

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

Best Practices & Recommendations

  • Specify base global templates as much as possible.
  • Only specify the Country and Language template document fields when required. This will make maintenance easier.
  • Try to use templates at the watchlist-level instead of the MedDRA Criteria level where possible.
  • You can have multiple watchlists under the same watchlist tag for easier management.

Create the Questionnaire Template Document

You must create a source questionnaire and add it as a controlled document template. Vault uses the questionnaire template to generate specific questionnaires for each Case and add the resulting document as an attachment on the Correspondence record. To learn more about controlled document templates, see Vault Platform Help.

You can create the questionnaire source file using any document type. However, we recommend that you use a .docx file format, which allows you to configure merge field tokens in the file.

Merge field tokens are replaced by field values from the relevant Case when the system generates a case questionnaire. To learn more about using merge fields, see Vault Platform Help.

Add Reply-To Contact Emails

Add Person records to configure the email addresses that should be the reply-to contact on questionnaire emails. You must select the reply-to contact when you configure the questionnaire template. The email does not have to be associated with a vault user.

  1. In Admin, go to Business Admin > Persons.
  2. Select Create.
  3. In the Create Person window, select the type of person, and then Continue.
    You can add any type of Person record to store the email address.
  4. On the Create Person page, specify the fields, and then select Save.

Result

The Person record is added and available to be selected as the reply-to email address in automated questionnaire emails.

Case Follow-Up Rules

Set up case Follow-Up Rules to add questionnaires for a given product. When this feature is enabled, basic Follow-Up Rules are added to your vault. You can customize these default Follow-Up Rules to specify the number of attempts to reach out to the reporter and how long to wait between each attempt.

Follow-Up Rule questionnaire templates use the Template > Correspondence (Template) > Questionnaire (Template) document type.

To set up questionnaires specific to certain adverse events of special interest, set up a Watchlist or MedDRA Term questionnaire template.

Customize a Case Follow-Up Rule

  1. In Admin, go to Business Admin > Follow-Up Rules.
  2. Open the Follow-Up Rule that you want to customize.
  3. Select Edit, and modify the following fields as required:
    Field Description
    Name Enter a name to describe the Follow-Up Rule.
    Rank This field does not currently control any functionality, but can be used to sort Follow-Up Rules in Business Admin.
    Total Attempts to Make Enter the total number of attempts that the system should make to email the reporter. After the first email, the system waits the specified Days Between Attempts before sending the next email, and each one thereafter. You can specify up to 10 attempts.
    Days Between Attempts Enter the number of days that should pass between each email attempt to the reporter. You can specify up to 30 days.
    Follow-up Type Select the follow-up type from the picklist. The Follow-up Type on an AER or Case must match the type that you select in this field to qualify for the questionnaire.
  4. Select Save.

After You Finish

Add one or more questionnaire template documents.

Add a Follow-Up Rule Questionnaire Template

We recommend adding the Follow-Up Rule questionnaire from the Follow-Up Rule record to automatically populate the Follow-Up Rule field and filter the document type field. However, you can also add templates from the Library tab.

  1. On the new Follow-Up Rule record, expand Template Documents.
  2. Select Add.
  3. Perform one of the following action sequences:
    • To use an existing template, select the document, and then select Close.
    • To add a new template, perform the following steps:
      1. Select Create.
      2. On the Upload Files (Step 1) page, upload the file and classify the document as Template > Correspondence (Template) > Questionnaire (Template), and then select Next.
      3. On the Upload Files (Step 2) page, specify the General Document Fields and Questionnaire Settings Fields, and then select Save.
        Once you save the document, you are directed back to the Follow-Up Rule record.
      4. Go to the template document in the Library.
        Select the document name link under Template Documents to find the document quickly.
      5. Move the document to a Steady state, such as Approved.
        The method to move the document to a steady-state depends on your vault's configuration. We recommend configuring a document workflow for approval. The document must be in a steady-state to be used as a controlled template.

Result

The template document is added to the Follow-Up Rule. You can add additional template documents as required. The system uses the Follow-Up Type along with the Questionnaire Settings to determine when to send the email questionnaire. See Questionnaire Matching Logic to understand how the system matches a Case to a template.

Watchlist and AESI Questionnaires

You can add questionnaire templates at the Watchlist-level and at the MedDRA Term level. If you add a questionnaire template for the entire Watchlist, and also add a questionnaire template for certain MedDRA Terms, the MedDRA Term template supersedes the Watchlist template for those terms only.

Note When a MedDRA Term supersedes a Watchlist, only the questionnaire for that MedDRA Term is sent for Cases and AERs with that MedDRA Term. The core questionnaire for the Watchlist is not sent.

Watchlist questionnaire templates use the Template > Correspondence (Template) > AESI Questionnaire (Template) document type.

Add a Questionnaire Template for a Watchlist or MedDRA Term

We recommend adding the questionnaire from the Watchlist or MedDRA Term record to automatically populate certain fields. However, you can also add templates from the Library tab.

  1. In Admin, go to Business Admin > Watchlists.
  2. Open the Watchlist for which you want to schedule automated email follow-ups.
  3. Perform one of the following action sequences, depending on where you want to add the template:
    • To add a template for the entire Watchlist:
      1. On the Watchlist record, expand Templates.
      2. Select Add.

      Note The Watchlist page layout must be configured to show the Templates section. If this section is not configured in your vault, you can add the document from the Library tab.

    • To add a template for specific MedDRA Term:
      1. Expand MedDRA Terms, and then open the term for which you want to add the questionnaire template.
      2. On the MedDRA Criteria record, expand Template Documents.
      3. Select Add.

      Note The MedDRA Term page layout must be configured to show the Template Documents section. If this section is not configured in your vault, you can add the document from the Library tab.

  4. Perform one of the following action sequences:
    • To use an existing template, select the document, and then select Close.
    • To add a new template, perform the following steps:
      1. Select Create.
      2. On the Upload Files (Step 1) page, upload the file and classify the document as Template > Correspondence (Template) > AESI Questionnaire (Template), and then select Next.
      3. On the Upload Files (Step 2) page, specify the General Document Fields and Questionnaire Settings Fields, and then select Save.
        Once you save the document, you are directed back to the Follow-Up Rule record.
      4. Go to the template document in the Library.
        Select the document name link under Template Documents to find the document quickly.
      5. Move the document to a Steady state, such as Approved.
        The method to move the document to a steady-state depends on your vault's configuration. We recommend configuring a document workflow for approval. The document must be in a steady-state to be used as a controlled template.

Result

The template document is added to the Watchlist or MedDRA Criteria. You can add additional template documents as required. The system uses the Watchlist or MedDRA Criteria along with the Questionnaire Settings to determine when to send the email questionnaire. See Questionnaire Matching Logic to understand how the system matches a Case to a template.

Questionnaire Template Document Fields

The following sections describe the fields that appear on questionnaire document templates.

General Document Fields

The following table describes the General fields. These fields appear on the Questionnaire (Template) document.

General Fields
General Template Document Fields
Field Description
Organization

(Required) Select the Organization to which this Follow-Up Rule applies.

The AER or Case Organization field must match the Organization that you select in this field.

Name (Required) Enter a name for this document. The name determines how the system displays and refers to the document in the user interface.
Title Enter an optional secondary identifier for the document.
Template Document Type (Required) Select Questionnaire.

Questionnaire Settings Fields

The following tables describe the Questionnaire Settings fields and usage for each type of questionnaire. These fields appear on the Questionnaire (Template) document.

Questionnaire Fields
Questionnaire Template Document Fields

Note the table captions that identify which template type each field appears for.

1. Fields for Follow-Up Rule Questionnaire Templates Only
Field Description
Follow-Up Rule

(Required) The Follow-Up Rule referencing this template. The system automatically populates this field when you add the template to a Follow-Up Rule.

The AER or Case Follow-Up Type field must match the Follow-Up Rule set in this field.

Products

(Required) Select the Products to which this questionnaire applies. You can enter multiple values in this field. The questionnaire will be sent to reporters of cases involving any of these products.

The AER or Case must match the Product that you select in this field, according to the following conditions:

  • AER — The Product or Study Product on the AER must match a Product that you select in this field.
  • Case — The Case must contain a Case Product that meets both of the following requirements:
    1. The Product or Study Product matches a Product set in this field.
    2. The Drug Role is Suspect or Interacting.
2. Fields for AESI Questionnaire Templates Only
Field Description
Watchlist

The Watchlist referencing this template. The system automatically populates this field when you add the template to a Watchlist.

The Case Watchlist Tags field must contain the tag for the Watchlist set in this field.

MedDRA Terms

The specific MedDRA Terms to which this questionnaire applies. When you add the template under a MedDRA term in a Watchlist, the system populates this field automatically.

Cases must contain a Case Adverse Event with a coded MedDRA term that matches the MedDRA Term set in this field.

3. Fields for All Questionnaire Templates
Field Description
Countries

To make this questionnaire specific to certain countries, select the countries to which this questionnaire applies. You can enter multiple values in this field.

The AER or Case must match a Country that you select in this field, according to the following conditions:

  • AER — The Reporter Country field must match the Country selected in this field.
  • Case — The Reporter Country field on the primary Case Contact must match the Country selected in this field. If the Reporter Country field is blank, then the system looks at the Event Country field on the primary Case Adverse Event.
  • If each of the above fields are blank, the system only matches questionnaires with an empty Country field.

Language

To make this questionnaire specific to certain languages, select the language to which this questionnaire applies. You can enter multiple values in this field.

The AER or Case must match a Language that you select in this field, according to the following conditions:

  • AER — The Reporter Language field must match a Language selected in this field.
  • Case — The Reporter Language field on the primary Case Contact must match a Language selected in this field. If the Reporter Language field is blank, then the system looks at the Event (Reported) - Language field on the primary Case Adverse Event.

If each of the above fields are blank, the system only matches questionnaires with the Country field either left blank or set to English.

Reply-To (Required) Select the contact whose email should be populated in the Reply-To field on the email sent to the reporter. The available options depend on the Reply-To records set up.

How Vault Safety Determines When to Send a Questionnaire

The following flowchart illustrates what the system looks at to determine whether to generate the Correspondence record and email questionnaire for a given Case:

Follow-Up Questionnaire Action Flowchart
Follow-Up Questionnaire Flowchart

The following list provides more information on each of the actions and decisions in the above flowchart:

  1. Once per day, at approximately midnight EST, to determine which Cases to consider sending a questionnaire for, the system searches for Cases and AERs with the Send Follow-Up checkbox selected.
  2. The system verifies that the Case or AER matches either a Follow-Up Rule, Watchlist tag, or MedDRA Term for which a questionnaire document template is configured.
  3. The system queries the Product, Language, and Country information from the Case or AER.
  4. The system verifies whether the Case or AER matches the criteria configured in the Questionnaire Settings section on a template document for the given Follow-Up Rule or Watchlist. If the Case matches multiple template documents, the system generates multiple questionnaires.
  5. If the Case or AER matches a questionnaire template, the system verifies that the reporter provided their consent to be contacted for more information to use the appropriate Correspondence Transmission Method:
    • If the Case or AER contains the reporter's email address and consent, then the system generates and sends an automatic Email Correspondence.
    • If the Case or AER is missing either the reporter's email or their consent, then the system generates a Manual Correspondence.

Example: Follow-Up Rule Cholecap Questionnaire

The following diagram shows an example questionnaire for a post-market product, Cholecap, and an example Case that would trigger this questionnaire being sent to the reporter:

Matching Questionnaire Settings with Case Data
Matching Questionnaire Settings with Case Data

Questionnaire Matching Logic

The following sections describes how the system determines matching between a Case or AER and the Questionnaire Settings for each template type.

Field Calculation

The following list describes how the system calculates the Product, Language, and Country when evaluating a Case or AER:

  • Product
    • AER — The Product on the AER.
    • Case — All Case Products where the Drug Role is Suspect or Interacting.
  • Country
    • AER — The Reporter Country field.
    • Case — The Reporter Country field on the primary Case Contact. If the Reporter Country field is blank, then the system looks at the Event Country field on the primary Case Adverse Event.
  • Language
    • AER — The Reporter Language field.
    • Case — The Reporter Language field on the primary Case Contact. If the Reporter Language field is blank, then the system looks at the Event (Reported) - Language field on the primary Case Adverse Event.

Note In addition to the criteria mentioned below, for the system to generate a questionnaire, the Case or AER must always match with the Organization specified on the questionnaire template.

Follow-Up Rule Questionnaire Matching

For Follow-Up Rules, the system evaluates each suspect or interacting Case Product for a matching questionnaire template using the following logic:

Priority Order Case⮀Questionnaire Matching System Action
Level 1
  • Product
  • Country
  • Language
Generates a questionnaire for each template that matches on all of these fields.
Level 2
  • Product
  • Country
  • Language

If either of the following conditions are true, then the system only considers templates with an empty Country field.

  • The Case or AER does not match the Country on a template
  • The Country fields are blank on the Case or AER

The system generates a questionnaire if there is a template matching on Product and Language with a blank Country field.

Level 3
  • Product
  • Country
  • Language

If the following conditions are true, then the system only considers templates with a Language field empty or set to English.

  • The Case or AER does not match the Language on a template
  • The Language fields are blank on the Case or AER

The system generates a questionnaire if there is a template matching on Product and Country with a blank or English Language field.

Level 4
  • Product
  • Country
  • Language

The system generates a questionnaire for each template that only matches on Product when both of the following conditions are met:

  • The Country field on the template document is blank
  • The Language field on the template document is blank or set to English

If neither of the above conditions are met, the system does not generate a questionnaire.

-
  • Product
  • Country
  • Language
Questionnaire not generated.

Watchlist and MedDRA Term Questionnaire Matching

For Watchlist questionnaires, the system evaluates each Case Adverse Event with a MedDRA term of special interest for a matching questionnaire template.

The system uses the same Country and Language matching as the Follow-Up Rule matching, with the additional considerations:

  1. MedDRA Term Questionnaire — If there is a MedDRA Term questionnaire matching the term coded on the Case Adverse Event, then only the specific MedDRA Term template is used to create the questionnaire.
  2. Watchlist Questionnaire — If there is no matching MedDRA Term questionnaire, but there is a Watchlist template matching the term coded on the Case Adverse Event, then the Watchlist template is used to create the questionnaire.
  3. Neither — If the event coded on the Case Adverse Event does not match either a Watchlist or MedDRA Term template, then no Watchlist questionnaire is sent.

Configure Adverse Event Watchlists
Configure Controlled Vocabularies
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