Sections in This Article
- Overview
- Prerequisite
- Trigger Case Questionnaire Generation
- Track and Monitor Correspondence
- Stop Further Reminder Emails
- Correspondence Methods
Overview
This page provides instructions for users, such as case processors, on how to generate follow-up questionnaires for a Case, Inbox Item, or AER. For administrator instructions on how to configure the questionnaires, see Set Up Scheduled Follow-Up Questionnaire Emails.
There are two types of questionnaires that your administrator 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 a Case, Inbox Item, or AER matches a questionnaire template and when you have recorded the reporter’s email address and consent to be contacted on the Case, Inbox Item, or AER.
If the primary Reporter’s email and consent information do not exist, the questionnaire can be sent to the non-primary Reporter, if available. If there are multiple non-primary Reporters, the system picks the last created one.
Note The option to email the non-primary reporter is only available for Cases and Inbox Items, not AERs.
Prerequisite
Before you can trigger a follow-up questionnaire, an administrator must have already configured the questionnaire
Trigger Case Questionnaire Generation
- Go to the Case, Inbox Item, or AER for which you want to send a questionnaire.
- In the Details section, specify the following fields:
- Follow-Up Rule: Select the Follow-Up Rule for the questionnaires with which the system should attempt to match the Case, Inbox Item, or AER:
- To evaluate the Case, Inbox Item, or AER for a certain Follow-Up Rule, select the rule from the picklist.
The system also attempts to match the Case, Inbox Item, or AER with any Watchlist or MedDRA Term questionnaires, regardless of which option you select. - To omit Follow-Up Rules and evaluate the Case, Inbox Item, or AER for Watchlist or MedDRA Term questionnaires only, select Adverse Events of Interest.
If Follow-Up Rule is left blank, the system uses Invalid Case (Missing Parameters) as the default value.
- To evaluate the Case, Inbox Item, or AER for a certain Follow-Up Rule, select the rule from the picklist.
- Send Follow-Up: Select this field.
This field is required for the system to evaluate whether this Case, Inbox Item, or AER matches the criteria for one or more questionnaires. After running the process to generate questionnaires, the system clears this field.
Follow-Up Questionnaire Fields in Case Details - Follow-Up Rule: Select the Follow-Up Rule for the questionnaires with which the system should attempt to match the Case, Inbox Item, or AER:
- Go to one of the following areas to add the reporter's email and consent:
- Case: Expand the Contacts section and go to the primary Case Contact record.
This section may be named Reporters, depending on your vault's configuration. - Inbox Item: Expand the Case Contacts section and go to the primary Case Contact record.
- AER: Go to the Reporters section.
- Case: Expand the Contacts section and go to the primary Case Contact record.
- Specify the following fields for the reporter:
- Email Address: Enter the reporter's email address.
The system sends the questionnaire to this address. - Email Consent Provided: If the reporter has provided their consent to be contacted for more information, select this field.
Note that when entering information for the Non-Primary Reporter record, if the Primary Reporter record has either the email address or consent field populated, the system will not email the non-primary Reporter. Instead, a manual Correspondence is created.
Both the email address and consent are required for the system to email the questionnaire automatically. If either of these fields are blank, the system creates a manual Correspondence instead.
Note Questionnaires can be emailed to a non-primary reporter for Cases and Inbox Items only, not AERs. The system chooses the last created non-primary reporter with an Email Address and Consent Provided.
Follow-Up Questionnaire Fields for Reporter Note When an imported AER or Inbox Item is promoted to a Case, the Email Address and Email Consent Provided fields are not copied over to the promoted Case.
- Email Address: Enter the reporter's email address.
Result
The system 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. The system 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, the system will generate 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, ensure to mark the Correspondence record as Completed to prevent the system from sending reminder emails.
Track and Monitor Correspondence
When a Case successfully triggers one or more questionnaires, the system generates a Correspondence record to track the request for follow-up information.
The system automatically generates the relevant questionnaire documents and attaches them to the Correspondence record.
Note Total attachment size cannot exceed 15MB.
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, the system generates a Correspondence record for each reply-to person.
View Case Correspondence
Generally there are two ways to find Correspondence records, but depending on your vault’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 Case, Inbox Item, or AER. The Correspondence section will show the records.
Note After promoting an AER or Inbox Item to a Case, the Correspondence disappears from the AER or Inbox Item and moves to the promoted Case.
Case Correspondence Fields
The following table describes the Correspondence fields and how the system automatically populates these fields:
| Field | Description |
|---|---|
| Case | The Case, Inbox Item, or AER for which the Correspondence record was generated. |
| Recipient (Case Contact) | The Case Contact (Reporter) for which the Correspondence record was generated.
The system 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, the system creates an Email Person record for the recipient using the email and information for the Reporter on the Case, Inbox Item, or AER, if one doesn’t already exist for that person. |
| Correspondence Method | The method of transmission. The system automatically sets this field to either Email or Manual. If the method is Email, the system automatically sends the Transmission. See the Correspondence Events log to track the progress. For more information on the differences between these, 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. The system sets the Reply-To field using the contact preconfigured by an administrator on the questionnaire template. |
| Case Identifier | The unique ID for the email subject line, being either the Case, Inbox Item, or AER name. The system does not change this field. If available, the system includes the WWUID value in the Case Identifier field. Otherwise, the system includes the External System UID in the Case Identifier field if this value is available. |
| Organization | The system 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 the questionnaire documents generated for that Correspondence record.
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.
The system 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. |
Note Consider the following when tracking email events:
- Not all email addresses support full event tracking, depending on the recipient email server security settings.
- Email receipt status updates may be delayed up to one hour.
View Email Messages from Correspondence Events
You can view the email body and attachments sent to the recipient from the Correspondence Event.
- From the Correspondence, expand Correspondence Events and then open a Correspondence Event.
- View the email message in the Body field.
Select Show More to see the entire message. - Expand Attachments to view the questionnaires sent to the recipient.
Stop Further Reminder Emails
Once you receive the questionnaire back from the reporter, you must move the Correspondence record to the Completed state, otherwise the system continues to send reminder emails as configured on the Follow-Up Rule.
- Go to the Correspondence record.
- Expand the Workflow State Change (
) menu, and then select the user action for Change State to Completed.
This action may be labeled differently, depending on how the action is configured in your vault.
Result
The system 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.
Note Vault Safety only supports sending automatic email correspondence. For manual correspondence, the system attaches the questionnaire to the correspondence record but the sending of the questionnaire must be handled outside of Vault Safety.
Email Correspondence (Automatic)
If both the reporter’s email address and consent are provided, Vault Safety can send any questionnaires that match the Case, Inbox Item, or AER automatically by email.
For automatic emails, Vault Safety sends reminders to the recipient. The reminders continue for the configured amount on the questionnaire template unless the Correspondence record is marked as complete.
An administrator can configure the number and frequency of reminder emails.
Manual Correspondence
If the email address or email consent is not available on the primary Case Contact (Reporter), but the Case, Inbox Item, or AER matches a questionnaire template, then the system 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.
The system does not take any further action for this type of Correspondence. Vault Safety does not support manual email correspondence with the reporter.
For manual Correspondence, you can download the questionnaire and handle the follow-up outside of Vault Safety. Your administrator may have configured a workflow to handle this process.
