Working with Health Authority Questions

Vault RIM provides functionality that allows you to capture, review, and track health authority questions from your regulatory documents. The Health Authority Question panel, available in the Doc Info pane for the configured document types, allows you to select question text within a document and Vault automatically extracts a Health Authority Question (HAQ) record for the question. You can view all questions extracted from a single document and add additional details to the records as needed to track your questions throughout their lifecycle.

Viewing Health Authority Questions

To view questions on a document:

Open the document that contains the questions you want to view.
On the Doc Info page, click the Health Authority Question panel icon () to open the Health Authority Question panel. The panel displays a card for each HAQ record extracted from highlighting a question in the document.
Click a question card to navigate directly to the highlighted question text within the document.
Click an HAQ record link in a question card to open the HAQ record in a pop-out browser window.

If a question card displays an orange caution icon (), the question was extracted from a previous version of the document. This means that its text is not highlighted in the current version of the document, and you will not be navigated to the question source in the document automatically.

Managing Health Authority Questions

This section describes how to manage questions in Vault RIM.

How Vault Extracts Health Authority Questions

The following behavior applies when you highlight a question in a document:

An HAQ record is created for the question.
A document annotation is created for the highlighted selection.
A question card is displayed in the Health Authority Question panel with an HAQ record link and question text.
The extracted question is linked in the Health Authority Question (health_authority_question__v) document field
HAQ join records are created for Application, Submission, Regulatory Objective, and Product Family based on the respective fields on the document at the time of question extraction.

When an HAQ record is created, the following fields are automatically populated on the record:

Any HAQ record fields that match the source document fields (name and data type) are populated with the document field information.
The Question Source field is populated with a link to the highlighted question annotation. Click See Source to navigate to the annotation on the source document.
The Question Source Document field is populated with a link to the source document. Click the Question Source Document link to navigate to the source document.

How to Extract Health Authority Questions

You can highlight question text within a document to extract an HAQ record. When Vault extracts an HAQ record, it populates the values on the HAQ record using values from matching fields on the source document.

Only one (1) user can extract questions from a document at a time. While a user is extracting questions, Vault locks the document until the user clicks Done, or 15 minutes have elapsed since the last question was extracted.

The following image displays an example of question cards and question text in the Health Authority Question panel for questions highlighted in a document:

To extract questions from a document:

Open the document that contains the questions you want to extract.
On the Doc Info page, click the Health Authority Question panel icon () to open the Health Authority Question panel.
Click Select Questions to enter Question Selection mode.
Highlight the question text in the document. Vault extracts an HAQ record, creates a document annotation for the highlighted selection, displays a question card with the HAQ record link and question text in the Health Authority Question panel, and displays the HAQ record link in the Correspondence Details section of the Doc Info panel.
When you are done highlighting questions, click Done in the Health Authority Question panel. Vault unlocks the document to allow other users to extract questions from the document.
To review the HAQ records that were extracted, click Review in the Health Authority Question panel. Vault opens a standalone tab that displays all of the HAQ records extracted from the document.

How to Delete Health Authority Questions

To delete a question:

Open the document that contains the questions you want to delete.
On the Doc Info page, click the Health Authority Question panel icon () to open the Health Authority Question panel.
Click the Delete icon () on the card of the question you want to delete. If the HAQ is referenced on previous versions of the document, the HAQ reference must be removed from the previous versions of the document before deleting.
In the confirmation message, click Delete to confirm that you want to delete the question, or click Cancel to cancel the deletion.

Limitations

The following limitations apply to HAQ functionality:

HAQ extraction supports document text only. If the document is a scan or an image that did not undergo OCR text extraction, question text cannot be highlighted and extracted. In addition, if the document contains images, figures, or tables, they cannot be highlighted and extracted unless they contain text that has undergone OCR text extraction.
You cannot highlight questions across two pages, and the amount of text that can be highlighted for a single question is limited according to Vault’s annotation limits.
You can extract up to 1,000 HAQs per document; however, the HAQ field in the document’s Information panel is limited to tracking and displaying 250 HAQ records.