Configuring Health Authority Question Extraction

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

If you have previously used HAQ functionality, you may have configured custom object fields and document fields to capture and display information related to questions. You can continue using most of the custom fields as described in the configuration below or transition to using the standard fields available in Vault.

Prerequisites

Ensure that the following prerequisites are met before configuring this functionality:

  • A lifecycle exists for the Health Authority Question (health_authority_question__rim) object.
  • The HAQ object has no required fields that do not match required fields on the Document Types where they will be extracted from or are being defaulted.
  • The Lifecycle State Stage ID (state_stage_id__sys) field must exist on the HAQ object. If it does not exist, complete the following steps:
    1. Create an Object Lifecycle Stage Group for the HAQ object.
    2. Add a Stage to the Lifecycle Stage Group and add a Lifecycle State to the Stage.
    3. Confirm that the Lifecycle State Stage ID (state_stage_id__sys) field exists on the HAQ object.
    4. Delete the Stage and Lifecycle Stage Group from the HAQ object.

Configuration Overview

To configure HAQ extraction functionality, complete the following steps:

  1. Configure the Health Authority Questions panel to be displayed for specific document types.
  2. Activate the HAQ document field and object fields.
  3. Configure the HAQ join objects.
  4. Optional: Update your custom configuration if you have previously used HAQ functionality.
  5. Add the document fields to the document types you configured to display the Health Authority Questions panel.
  6. Update any required fields on the HAQ object.
  7. Update any document lifecycles as needed.

Configuring the Health Authority Questions Panel Document Types

To enable questions to be extracted from documents, configure the Health Authority Questions panel to be displayed for each document type, subtype, or classification that may contain questions. The Health Authority Questions panel can be enabled for all document types, subtypes, and classifications except the following:

  • Submissions Archive (archive__v)
    • Content (content__v)
    • Structure (structure__v)
  • IDMP (idmp__v)
    • EU IDMP Submission (eu_idmp_submission__v)
    • eAF FHIR Output (eaf_fhir_output__v)
  • Submission Ready (submission_ready__v)
    • Clinical Study (clinical_study__v)
    • Nonclinical Study (nonclinical_study__v)
    • Report (report__v)
  • UDI (udi__v)
    • UDI Submission (udi_submission__v)
  • Unclassified (undefined__v)

To configure the Health Authority Questions panel for a document type:

  1. Navigate to Admin > Configuration > Application Configurations > RIM Document Type Configurations.
  2. Click Create to create a RIM Document Type Configuration. 
  3. Select the Document Type, and enter a Name and Label for the document type configuration. We recommend using the associated Document Type, Subtype or Classification Name and Label for these fields. When you select a Type or Subtype, the configuration applies to all Subtypes and Classifications under it.
  4. Select Yes for Enable HAQ Panel to enable the panel and allow questions to be extracted from the selected document type. 
  5. Click Save.

Activating Health Authority Question Fields

If your organization has previously implemented HAQ functionality using custom fields, you can continue to use a majority of those custom fields as long as the fields that should be copied from the document to the HAQ record have the same Name. Alternatively, you can activate and use the standard fields.

Activating Required Fields

Activate the following required HAQ fields:

  1. Navigate to Admin > Configuration > Document Fields and set the Health Authority Questions (health_authority_question__v) document field to Active. This standard document field must be activated to use this feature.
  2. Navigate to Admin > Configuration > Objects > Health Authority Question (health_authority_question__rim) and set the following object fields to Active. These fields must be activated to use this feature:
    • Question Source (question_source__v)
    • Question Source Document (question_source_document__v)
    • Question Source Document ID (question_source_document_id__v)
    • Question Annotation ID (question_annotation_id__v)

Configuring Optional Fields

HAQ object fields can be configured to be copied from the document where the question is extracted. You can use custom HAQ object fields with the same name as the document fields below. If you are using custom fields, you may need to rename the field on either the document or the HAQ object so that they match. See Reviewing Current Custom Fields for more information about reviewing your current custom object fields if you have previously used them for HAQ functionality.

Alternatively, you can change the following standard object fields to Active for the Health Authority Question (health_authority_question__rim) object: 

  • Primary Product Family (product__v)
  • Related Application (applications__v)
  • Country (country__v)
  • Question Topic (question_topic__v)
  • CTD Sections Impacted (ctd_sections_impacted__v)

You can also configure the standard document fields below. These fields are not required, and if they remain Inactive, Vault maps the respective custom document field with the same name instead:

  • Commitments (commitment__v)
  • Correspondence Scope (correspondence_scope__v)
  • Date Received (date_received__v)
  • Method of Communication (method_of_communication__v)
  • Regulatory Objectives (regulatory_objectives__v)
    • Although this field is optional, it is required for Vault to automatically create HAQ Regulatory Objective records during question extraction. If the custom Regulatory Objectives document field is used instead, the join is not automatically populated.

Configuring Health Authority Question Join Objects

Create relationships for the join objects below between the Health Authority Question (health_authority_question__rim) parent object and the indicated parent object. The specific document field indicated must be configured and set to drive the automatic creation of the relationship, and custom document fields are not supported.

  • Health Authority Question Submission (health_authority_question_submission__v)
    • Vault creates a record for each Submission (submissions__v) set on the document.
  • Health Authority Question Application (health_authority_question_application__v)
    • Vault creates a record for each Application (applications__v) set on the document.
  • Health Authority Question Product Family (health_authority_question_product_family__v)
    • Vault creates a record for each Product Family (product__v) set on the document.
  • Health Authority Question Regulatory Objective (health_authority_question_regulatory_objective__v)
    • Vault creates a record for each Regulatory Objective (regulatory_objectives__v) set on the document.

Ensure that the appropriate permissions are added for those join objects for the users who will be extracting questions. In addition, add the above join objects to the Health Authority Question (health_authority_question__rim) object page layouts.

Updating the Custom Configuration

This configuration section is optional and is only applicable if you have previously used custom configuration for HAQ functionality.

Reviewing Current Custom Fields

If you have previously used HAQ functionality, you may have configured custom object fields and document fields to capture and display information related to questions. You can continue using most of the custom fields or transition to using the standard fields available in Vault.

Assess the current custom fields on the HAQ document field and HAQ object that should be copied from the document to the HAQ record during extraction to ensure that they have matching names.

To continue using the custom fields, rename the custom fields as needed to match their corresponding mapped field. For example, if you use the custom related_application__c object field on the HAQ object to capture the application related to the question, rename the custom object field to application__c to match the standard application__v document field. This ensures that the HAQ record can be correctly populated with information from the source document using field-matching logic.

Refer to the field names listed in the Activating Required Fields section to ensure that all of your custom object field names match the corresponding document field names. If you continue to use custom object fields, ensure that the standard field with the same name remains inactivated.

Updating Additional Field Names

Your organization’s processes may include using additional document fields to capture information related to questions. Assess whether the fields should be defaulted from the document to the HAQ record. If so, ensure that the fields have the same name and data type on both the document and the HAQ object so that data is correctly mapped to the HAQ record.

Updating the Correspondence Details Field Layout

The standard Correspondence Details field layout contains the following document fields:

  • Issued/Start Date
  • Date Received
  • Method of Communication
  • Correspondence Scope
  • Health Authority Questions
  • Commitments

If your organization has previously used custom fields in a custom Correspondence Details field layout, you may need to update the custom field layout so that your Documentation Information panel does not display two Correspondence Details sections with duplicate data. 

To ensure that duplicate data is not displayed on the Documentation Information panel, delete, inactivate, or move the custom fields. Navigate to Admin > Configuration > Document Fields for each custom field and change its Display Section to a different field layout, set its Status to Inactive, or delete the custom field. If you deactivate or delete the custom field, ensure that you activate its corresponding standard field. 

Migrating Data from Custom Fields to Standard Fields

If you begin using the standard fields and have previously used custom fields, you may also need to perform a data migration to migrate existing values in custom fields to the new standard fields. This will ensure that the correct document information is displayed in the Correspondence Details section of the Documentation Information panel.

Updating Criteria VQL to use Standard Objects

If the Health Authority Question (health_authority_question__rim) object has criteria VQL that uses custom object fields and you are transitioning to using standard object fields, update the criteria VQL to reference the new standard fields. For example, if the criteria VQL references a custom Country (country__c) object field, update the VQL to reference the standard Country (country__v) object field instead.

Adding Document Fields to the Configured Document Types

Navigate to Admin > Configuration > Document Fields and add the HAQ document fields to the document types you configured to display the Health Authority Questions panel. See Managing Document Fields and Working with Shared Fields for more information.

Updating Required Fields on the Health Authority Question Object

Required fields on the Health Authority Question (health_authority_question__rim) object will cause errors when using this feature if their values are not defaulted or if they are mapped from a document but not required on the document. 

Navigate to Admin > Configuration > Objects > Health Authority Question (health_authority_question__rim)  and review whether any of the fields are required. If any fields are required and their values are not defaulted, or if they are mapped from a document but not required on the document, edit the object field and deselect User must always enter a value (required). You may then make the field required using lifecycle entry criteria to enforce that the field is not blank on the next lifecycle state after the Initial state.

Updating Document Lifecycles

Assess whether the document lifecycles for document types configured for question extraction require updates. If questions will be extracted when the document is in a lifecycle state that is not Approved and the document will be approved after extraction is complete, update any entry criteria on the Approved lifecycle state for Field Annotations (Unresolved) equals 0. We recommend adding a condition for this entry criteria to run only if the Classification is not configured for question extraction.

The following permissions are required for configuring HAQ extraction functionality:

Type Permission Controls
Security Profile Object > Health Authority Question: Read, Create, Edit, Delete Ability to create and edit the HAQ object; ability to extract questions from a document; ability to delete HAQ records
Security Profile Object > Health Authority Question Submission: Read, Create Ability to create HAQ Submission records when extracting questions
Security Profile Object > Health Authority Question Application: Read, Create Ability to create HAQ Application records when extracting questions
Security Profile Object > Health Authority Question Product Family: Read, Create Ability to create HAQ Product Family records when extracting questions
Security Profile Object > Health Authority Question Regulatory Objective: Read, Create Ability to create HAQ Regulatory Objective records when extracting questions
Security Profile Admin > Document Fields: Read, Create Ability to set the HAQ document field when extracting questions
Document Role Annotate Ability to highlight questions in a document