If a Case requires follow-up information, you can send online questionnaires to Case Contacts or generate documents for follow-up correspondence.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
About Online Questionnaire Generation
For email methods of correspondence, Vault generates questionnaires and emails the applicable Case Contacts for follow-up information. This allows you to gather follow-up information, such as for post-market Cases and clinical trial Cases. Depending on your Admin’s configuration, you can generate follow-up questionnaires in the following ways:
- Move the Case to a certain lifecycle state
- Run the Create Correspondence and Questionnaires action
Vault then sends the online questionnaire to the following types of Case Contacts:
- Health Care Professional
- Patient Contact
- Reporter
For manual methods of correspondence, Vault does not email recipients. Instead, Vault generates documents from configured document templates.
Note: For information on how to generate and send follow-up email questionnaires to Case Reporters, see Send a Follow-Up Email Questionnaire to a Case Reporter.
Prerequisites
Before you can generate follow-up online questionnaires, your Admin must have already configured the questionnaire and enabled online questionnaires for follow-ups.
Your Admin can also enable importing online questionnaire responses to follow-up Inbox Items.
Generate Questionnaires
To generate questionnaires or documents from templates
- Navigate to the Case for which you want to send a questionnaire.
- In the Contacts section, ensure the applicable Case Contacts have provided their email address and consent:
- Email field contains a value.
- Email Consent Provided checkbox is selected.
- Depending on your Admin’s configuration, you can generate questionnaires in the following ways:
- Automatically generate questionnaires by processing the Case to the applicable lifecycle.
- Manually generate questionnaires:
- From the All Actions menu, select Create Correspondence and Questionnaires.
- In the window, select the applicable follow-up rules.
- Select Complete.
Results
Vault evaluates this Case against the selected Follow-up Questionnaire Rules as well as any Watchlists. Vault generates a Questionnaire type of Transmission for each matching Follow-up Questionnaire Rule and Case Contact pair. For example, if there are two (2) Case Contacts and two (2) selected Follow-up Questionnaire Rules, Vault generates four (4) Questionnaire records. For manual methods of correspondence, each Questionnaire includes all applicable correspondence documents in the language associated with the Country of the Case Contact from all applicable templates.
Post-Questionnaire Generation Steps
Vault generates Questionnaire types of Transmission records for processing when a Follow-up Questionnaire Rule is met. When the Correspondence Method of the Correspondence is Email, recipients receive an email about follow-up correspondence. Each email includes a public access link (PAL), which allows the recipient to access the online questionnaire. Recipients can securely respond to questionnaires without logging into a Vault and without the ability to view or access any areas of your Vault. PALS are valid until a reminder with a new PAL is sent out with a new link, or for 30 days if there is no reminder is scheduled.
If your Admin did not configure your Vault to automatically send questionnaires to recipients, you can review the generated questionnaires by adding or removing questions and editing pre-populated answers. After the review is complete, select the Ready to Send checkbox for Vault to send the email.
Post-Questionnaire Completion Steps
After the recipient completes an online questionnaire, Vault creates an Inbox Item and sets the following:
- State: Marked as Follow-up
- Intake Method: Online Questionnaire
- Intake Format: Data
- Source Questionnaire: Links to the online questionnaire
If configured by your Admin, Vault also maps questionnaire responses to Inbox Item fields for the following objects:
- Case
- (Primary) Case Adverse Event
- (Primary) Case Product
- Case Contact
As the Intake user, review the information and promote the Inbox Item accordingly. Questions with responses appear in the Source Data pane for the applicable Inbox Item section. Select Show More to see the complete response. When a response to a text question exceeds the maximum character limit of the associated question field mapping, Vault does not import the response and instead displays the response text in the Questionnaire Response subsection of the Source Data pane.
Track and Monitor Correspondence
See Send a Follow-up Email Questionnaire to a Case Reporter for more details.
Case Correspondence Fields
The following table describes the Correspondence fields and how Vault populates these fields:
Field | Description |
---|---|
Case | The Case for which Vault generates the Correspondence record. |
Recipient (Case Contact) | The Case Contact for which Vault generates the Correspondence record. |
Correspondence Method | The method of transmission. Vault sets this field to either Email or Manual. If the method is Email, Vault sends the Transmission. See the Correspondence Events log to track the progress.
For more information on the differences between these correspondence methods, see Send a Follow-Up Email Questionnaire to a Case Reporter. |
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 based on your Admin's configuration. |
Case Identifier | The Case Number. Vault does not change this field. |
Organization | Vault populates the Organization from the Case and questionnaire. |
Due Date | The date when the first reminder email will send. |
Transmission Date | The date and time when the initial email was sent to the recipient. |
Stop Further Reminder Emails
For information on stopping further reminder emails, see Send a Follow-up Email Questionnaire to a Case Reporter.