If an Inbox Item or Case is missing information, you can send an automated preconfigured follow-up questionnaire to the primary Case Reporter.

Overview

This page provides instructions for users, such as case processors, on how to generate follow-up questionnaires for an Inbox Item or Case. For Admin instructions on how to configure the questionnaires, see Set Up Scheduled Follow-Up Questionnaire Emails.

There are two (2) types of questionnaires that your Admin can set up:

  • Follow-Up Rule questionnaires
  • Watchlist questionnaires

The following sections describe these types, and how to trigger the generation of each. The questionnaire is sent to the primary Case Reporter.

Vault Safety automatically generates and emails the questionnaire to the primary Case Reporter when an Inbox Item or Case matches a questionnaire template and when you have recorded the reporter’s email address and consent to be contacted.

If the primary Reporter’s email or consent information does not exist, the questionnaire can be sent to the non-primary Reporter, if available. If there are multiple non-primary Reporters, Vault picks the last created one.

Prerequisite

Before you can trigger a follow-up questionnaire, your Admin must have already configured the questionnaire and enabled Automatic Email of Case Questionnaire & Scheduled Reminders.

Trigger Case Questionnaire Generation

To trigger questionnaire generation:

  1. Go to the Inbox Item or Case for which you want to send a questionnaire.
  2. In the Details section, specify the following fields:
    1. Follow-Up Rule Select the Follow-Up Rule for the questionnaires with which Vault should attempt to match the Inbox Item or Case:
      • To evaluate the Inbox Item or Case for a certain Follow-Up Rule, select the rule from the picklist. Vault also attempts to match the Inbox Item or Case with any Watchlist or MedDRA Term questionnaires, regardless of which option you select.
      • To omit Follow-Up Rules and evaluate the Inbox Item or Case for Watchlist or MedDRA Term questionnaires only, select Adverse Events of Interest
    2. Send Follow-Up Select this field. This field is required for Vault to evaluate whether this Inbox Item or Case matches the criteria for one or more questionnaires. After running the process to generate questionnaires, Vault clears this field.
      Follow-Up Questionnaire Fields in Case Details
  3. Go to one of the following areas to add the reporter’s email and consent:
    • Inbox Item: Expand the Case Contacts section and go to the primary Case Contact record.
    • Case: Expand the Contacts section and go to the primary Case Contact record. This section may be named Reporters, depending on your Admin’s configuration.
  4. Specify the following fields for the reporter:
    1. Email Address Enter the reporter’s email address. Vault sends the questionnaire to this address.
    2. Email Consent Provided If the reporter has provided their consent to be contacted for more information, select this field.


    If you do not have the primary Case Contact information, complete the above information for a non-primary Case Contact, if available. Both the email address and consent are required for Vault to email the questionnaire automatically. If either of these fields are blank, Vault creates a manual Correspondence instead.

Vault chooses the last created non-primary Reporter with an email address who has provided consent.

Follow-Up Questionnaire Fields for Reporter

Result

Vault will evaluate this Case against the Follow-Up Rule as well as any Watchlists or MedDRA Terms, depending on the option that you select in the Case Follow-Up Rule field. Vault checks each Case with the Send Follow-Up checkbox selected once per day, at approximately midnight EST.

If there is a match to a questionnaire, Vault generates a Correspondence record for this Case. After evaluating the Case, the Send Follow-Up checkbox is cleared.

Next Steps

For automatic correspondence, once the reporter replies to the email, mark the Correspondence record as Completed to prevent Vault from sending reminder emails.

Track and Monitor Correspondence

When a Case successfully triggers one (1) or more questionnaires, Vault generates a Correspondence record to track the request for follow-up information.

Vault automatically generates the relevant questionnaire documents and attaches them to the Correspondence record.

If a Case triggers multiple questionnaires, they are attached and sent in the same Correspondence record. However, if there are questionnaires with different reply-to email addresses, Vault generates a Correspondence record for each reply-to person.

View Case Correspondence

Generally, there are a few ways to find Correspondence records, but depending on your Admin’s configuration these may vary:

  • To view all Correspondence, from the primary navigation bar, go to Transmissions > Correspondence.
  • To view Correspondence for a specific Case, go to that Inbox Item or Case. The Correspondence section will show the records.

After promoting an Inbox Item to a Case, Correspondence is included on both the Inbox Item and the Case.

Case Correspondence Fields

The following table describes the Correspondence fields and how Vault populates these fields:

Field Description
Case The Inbox Item or Case for which the Correspondence record was generated.
Recipient (Case Contact) The Case Contact (Reporter) for which the Correspondence record was generated.
Vault populates this field with the primary Reporter on a Case.
Recipient (Person) The Person record with the email information for the Reporter.
When generating Correspondence, Vault creates an Email Person record for the recipient using the email and information for the Reporter on the Inbox Item or Case, if one (1) doesn't already exist for that person.
Correspondence Method

The method of transmission. Vault automatically sets this field to either Email or Manual. If the method is Email, Vault automatically sends the Transmission. See the Correspondence Events log to track the progress.

For more information on the differences between these options, see the Correspondence Methods section.

Destination Email The email address for the questionnaire recipient.
Reply-To

The Person record with the email address that should be populated in the Reply-To field on the Email Transmission.

Vault sets the Reply-To field using the contact preconfigured by an Admin on the questionnaire template.

Case Identifier The unique ID for the email subject line, being either the Inbox Item or Case name. Vault does not change this field. If available, Vault includes the WWUID value in the Case Identifier field. Otherwise, Vault includes the External System UID in the Case Identifier field if this value is available.
Organization Vault automatically populates the Organization from the Case and questionnaire.
Due Date The date when the first reminder email will be sent.
Transmission Date The date and time when the initial email was sent to the recipient.

View Questionnaires Attached to Correspondence

On the Correspondence record, expand Attachments to view its questionnaire documents.

Correspondence Events Log

For automatic emails, Vault Safety tracks certain key events in the Correspondence record. Review the events log to view these events and monitor when the email was sent and opened.

Vault logs the following events:

Event Type Description
Initial Message Sent The initial email was sent to the recipient.
Follow-Up Message Sent A reminder email was sent to the recipient.
Message Opened An email was opened by the recipient.
Error The email could not be delivered to the recipient.

View Email Messages from Correspondence Events

You can view the email body and attachments sent to the recipient from the Correspondence Event.

  1. From the Correspondence, expand Correspondence Events and then open a Correspondence Event.
  2. View the email message in the Body field.
    • Select Show More to see the entire message.
  3. Expand Attachments to view the questionnaires sent to the recipient.

Stop Further Reminder Emails

Once you receive the questionnaire back from the reporter, move the Correspondence record to the Completed state, otherwise Vault continues to send reminder emails based on the Follow-Up Rule setup.

  1. Go to the Correspondence record.
  2. Expand the Workflow State Change (Workflow State Change) menu, and then select Change State to Completed.
    Depending on your Admin’s configuration, this action may have a different name.

Result

Vault changes the Correspondence record state to Completed and does not send any further reminder emails.

Correspondence Methods

Vault Safety can generate Correspondence with the transmission method as either manual or automatic.

Email Correspondence (Automatic)

If both the Reporter’s email address and consent are provided, Vault can automatically email any questionnaires that match the Inbox Item or Case.

For automatic emails, Vault sends reminders to the recipient. The reminders continue for the configured amount on the questionnaire template unless the Correspondence record is marked as complete.

Reminders are sent once per day, at approximately midnight EST.

Manual Correspondence

If the email address or email consent is not available on the primary Case Contact (Reporter), but the Inbox Item or Case matches a questionnaire template, then Vault generates a Correspondence record in the Ready state and the Correspondence Method as Manual.

The questionnaire document is generated and included on the manual Correspondence record as an attachment.

Vault does not take any further action for this type of Correspondence. Vault does not support manual email correspondence with the Reporter.

For manual Correspondence, download the questionnaire and handle the follow-up outside of Vault Safety. Your Admin may have configured a workflow to handle this process.