Send a Follow-Up Online Questionnaire to Case Contacts

If a Case requires follow-up information, you can send online questionnaires to Case Contacts.

About Online Questionnaire Generation

Vault can automatically generate and send online questionnaires to the desired Case Contacts for Follow-up Case information. You can use this feature to gather follow-up information for post-market Cases, clinical trial Cases, and more.

Online questionnaires can be generated in the following ways:

• Vault triggers questionnaire generation when the Case enters a certain lifecycle state.
• You can trigger questionnaire generation using a record action.

Vault then sends the online questionnaire to the Case Contacts who have provided their email address and consent and are of the following types:

• Health Care Practitioner
• Patient
• Reporter

Prerequisites

Before you can trigger 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.

Trigger Online Questionnaire Generation

To trigger online questionnaire generation:

1. Go to the Case for which you want to send a questionnaire.
2. In the Contacts section, ensure the desired Case Contacts have provided their email address and consent.
3. Use one (1) of the following methods to trigger questionnaire generation:
   1. If your Vault is configured to automatically generate questionnaires once a Case lifecycle is reached, continue processing the Case until the respective state. Contact your Admin for more information.
   2. To trigger questionnaire generation manually, go to the All Actions menu and select Generate Follow-up Questionnaires.
      A Generate Follow-up Questionnaires window appears.
      1. Vault automatically displays the follow-up rules the Case satisfies. Confirm or edit the selection from the dropdown menu.
      2. Select Complete.

Results

Vault evaluates this Case against the selected Follow-up Questionnaire Rules as well as any Watchlists or MedDRA Terms.

If there is a match to one (1) or more questionnaires, Vault generates a Questionnaire record for each 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. Vault then links the questionnaires in the Questionnaire record.

Questionnaires are only accessible by Vault Users in the specified Case Access Group with PII access.

Post-Questionnaire Generation Steps

If your Admin has configured your Vault to automatically send questionnaires to recipients when a Follow-up Questionnaire Rule is met, Vault sends an email to each Case Contact. The recipient can access each online questionnaire through a public access link (PAL) in the email and complete it in Vault. During questionnaire completion, the user cannot access other Vault areas. The public access link (PAL) is valid until a reminder is sent out with a new link, or for 30 days if there is no reminder 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, ensure the Ready to Send field is checked off for Vault to send the email.

Post-Questionnaire Completion Steps

After the recipient completes the 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

Questions with responses will appear in the Source Data pane for the applicable Inbox Item section.

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.

When the response text is greater than 500 characters, select Show More to see the complete response.

As the Intake user, review the information and promote the Inbox Item accordingly.

Track and Monitor Correspondence

See Send a Follow-up Email Questionnaire to a Case Reporter for details on the following:

• Tracking Correspondence records
• Viewing Correspondence records
• Viewing the Correspondence Events Log

Case Correspondence Fields

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

Field	Description
Case	The Case for which the Correspondence record was generated.
Recipient (Case Contact)	The Case Contact for which the Correspondence record was generated.
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 using the contact preconfigured by your Admin on the questionnaire template.
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 be sent.
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.