22R3 Data Model Changes: Safety

Pre-Release Date: October 31, 2022 | Release Date: November 23, 2022 & December 9, 2022

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Safety and SafetyDocs data model. These data model updates are automatically included in all Safety and SafetyDocs Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 22R3.

For information about data model changes related to Vault Platform, see 22R3 Data Model Changes: Platform.

Data Model Updates - Safety

The following changes were made to support the Automated Case Promotion for API Transmissions feature:

• Added the following fields to the Adverse Event Report (adverse_event_report__v) document type:
  • Enable Auto Promote (enable_auto_promote__v)
  • Serious Merge Method (serious_merge_method__v)
  • Non-Serious Merge Method (non_serious_merge_method__v)
• Added the following picklist values to the Enable Auto Promote (enable_auto_promote__v) field:
  • No (no__v)
  • Yes (yes__v)
• Added the following picklist values to the Serious Merge Method (serious_merge_method__v) and Non Serious Merge Method (non_serious_merge_method__v) fields:
  • Manual (manual__v)
  • Smart (smart__v)
  • Override (override__v)
• Added the following picklist item to the Document Type (document_types__v) picklist:
  • JSON V1 (json_v1__v)

The following changes were made to support the Automatic Email of Case Questionnaire for Inbox Items feature:

• The standard Document field Products (products_correspondence__v) is no longer a required field.

The following changes were made to support the Cosmetics, OTC Drugs, Nutritionals, and Non-Physical Devices for Case Processing feature:

• Added the Product (product__v) object type to the Product (product__v) object.
• Added the Default Registration (default_registration__v) field to the Product Registration (product_registration__v) object.
• Added the following items to the Product Type (product_type__v) picklist:
  • Cosmetic (cosmetic__v)
  • OTC Drug (otc_drug__v)
  • Nutritional (nutritional__v)
• Added the Company Product (company_product__v) object type to the Case Product (case_product__v) object.
• Added the Globally Registered As (globally_registered_as__v) field to the Case Product (case_product__v) object (Company Product object type only).

The following changes were made to support the Domestic Case Processing for Agency Jurisdictions feature:

• Updated the EMA.C.2.r.2.5-1 (ema_c2r25_1__v) Validation Criteria record.
• Added the EMA.C.2.r.2.5-2 (ema_c2r25_2__v) Validation Criteria record.

The following changes were made to support the Generate Transmissions and AutoSubmit Enhancement feature:

• Added “Suppress File Generation for Auto-Submit Transmissions” to Submissions section under Admin > Settings > ICSR Reporting.

The following changes were made to support the IMDRF: Dictionary Maintenance, Case Processing, and Submissions feature:

• Added “System manages field value” option to the Name (name__v) field on the Localized Case Product Device Code (localized_case_product_device_code__v) and Case Product Device Code (case_product_device_code__v) objects.
• Added the following notification templates:
  • IMDRF Version Update Importing (imdrf_version_update_importing__v)
  • IMDRF Version Update Succeeded (imdrf_version_update_success__v)
  • IMDRF Version Update Failed (imdrf_version_update_failure__v)
• Added the following Validation Criteria records:
  • FDA.B.4.k.20.FDA.19.1b (fda_b4k20fda191b__v)
  • FDA.VAERS.G.k.12.r.3.r (fda_gk12r3r__v)
• Added the Localized Case Product Device Code (localized_case_product_device_code__v) object.
• Added the Localized Case Product Device Code LC (localized_case_product_device_code_lc__v) object lifecycle
• Added the following fields to the Localized Case Product Device Code (localized_case_product_device_code__v) object:
  • Localized Case Product (localized_case_product__v)
  • Case Product (case_product__v)
  • Device Code (Type device_code_type__v)
  • Local Code (local_code__v)
  • Case (case__v)
  • Localized Case (localized_case__v)
  • Case Product Device Code (case_product_device_code__v)
• Added the Case Product Device Code (case_product_device_code__v) object.
• Added the Case Product Device Code Lifecycle (case_product_device_code_lc__v) object lifecycle.
• Added the following fields to the Case Product Device Code (case_product_device_code__v) object:
  • Case Product (case_product__v)
  • Case (case_version__v)
  • Organization (organization__v)
  • Device Code Type (device_code_type__v)
  • Device Code (device_code__v)
• Added the Active IMDRF Version (active_imdrf_version__v) field to the Dictionary object.
• Added the IMDRF Device Code (imdrf_device_code__v) object.
• Added the IMDRF Device Code Lifecycle (imdrf_device_code_lifecycle__v) lifecycle.
• Added the Device Code Type (device_code_type_picklist__v) picklist.
• Added the following values to the Device Code Type (device_code_type_picklist__v) picklist:
  • Medical Device Problem (medical_device_problem__v)
  • Type of Investigation (type_of_investigation__v)
  • Investigation Finding (investigation_finding__v)
  • Investigation Conclusion (investigation_conclusion__v)
  • Health Effects - Clinical Signs and Symptoms or Conditions (health_effects_clinical_sign__v)
  • Health Effects - Health Impact (health_effects_health_impact__v)
  • Medical Device Component (medical_device_component__v)
• Added the IMDRF Version (imdrf_version__v) picklist.
• Added the following fields to the IMDRF Device Code (imdrf_device_code__v) object:
  • Device Code Type (device_code_type__v)
  • IMDRF Version (imdrf_version__v)
  • Level 1 - Code (level_1_code__v)
  • Level 1 - Term (level_1_term__v)
  • Level 1 - Definition ( level_1_definition__v)
  • Level 2 - Code (level_2_code__v)
  • Level 2 - Term (level_2_term__v)
  • Level 2 - Definition ( level_2_definition__v)
  • Level 3 - Code (level_3_code__v)
  • Level 3 - Term (level_3_term__v)
  • Level 3 - Definition (level_3_definition__v)

The following changes were made to support the Localized Case Child and Grandchild Record Deletion from Case feature:

Added a new Other Options section to Admin > Settings > Safety General Settings with the following option:

• Allow localized record deletion from Case

The following changes were made to support the MedDRA Bulk Recode Cases feature:

• Added the following new picklists:
  • Case State (case_state__v)
  • Bulk Action Status (bulk_action_status__v)
• Added the following values to the Case State (case_state__v) picklist:
  • Approved/Closed (approved_closed__v)
  • Open (open__v)
• Added the following values to the Bulk Action Status (bulk_action_status__v) picklist:
  • Preview Generated (preview_generated__v)
  • Bulk Action Initiated (bulk_action_initiated__v)
  • Bulk Action Completed (bulk_action_completed__v)
• Added the Dictionary Bulk Action (dictionary_bulk_action__v) object.
• Added the following fields to the Dictionary Bulk Action (dictionary_bulk_action__v) object:
  • Dictionary (dictionary__v)
  • Replacement MedDRA Version (replacement_meddra_version__v)
  • Organization (organization__v)
  • Case State (state_name__v)
  • Report Type (report_type__v)
  • Study Type (study_type__v)
  • Study (study__v)
  • Bulk Action Status (bulk_action_status__v)
• Added the Recoded (recoded_state__v) field to the Case Lifecycle (case_processing_lifecycle__v).
• Added the MedDRA Bulk Action Id (meddra_bulk_action_id__v) field to the MedDRA (meddra__v) object.

The following changes were made to support the MedDRA Synonym Field Exclusion and Candidate Auto-Creation feature:

• Added the following fields to the MedDRA Synonym (meddra_synonym__v) object:
  • MedDRA Languages (meddra_languages__v)
  • Excluded MedDRA Fields (excluded_meddra_fields__v)
• Added the following field to the MedDRA Dictionary (meddra_dictionary__v) object type:
  • Enable Synonym Candidate Auto-Creation (enable_synonym_candidate_autocreation__v)

The following changes were made to support the New Duplicate Search Algorithm feature:

• Added the Duplicate Search Options section to the Case Promotion Settings (case_promotion_settings__v) page, containing the following settings:
  • Perform Deep Duplicate Search on Spontaneous Cases
  • Max Number of Spontaneous Search Results
  • Perform Deep Duplicate Search on Study Cases
  • Max Number of Study Search Results
  • Perform Deep Duplicate Search on Inbox Items

The following changes were made to support the Product Hierarchy Data Model feature:

• Added the Product Family (product_family__v) object with the following fields:
  • Name (name__v)
  • Organization (organization__v)
  • Family Datasheet (datasheet__v)
  • Therapeutic Area (therapeutic_area__v)
• Added the Product Family (product_family__v) field to the Product (product__v) object (all types).
• Added the Inactive Ingredient (inactive_ingredient__v) object with the following fields:
  • Name (name__v)
  • Organization (organization__v)
  • Inactive Ingredient Name (inactive_ingredient_name__v)
• Added the Inactive Ingredient Registration (inactive_ingredient_registration__v) object with the following fields:
  • Name (name__v)
  • Organization (organization__v)
  • Inactive Ingredient Name (inactive_ingredient_name__v)
  • Product Registration (product_registration__v)

The following changes were made to support the Remedial Actions and Malfunction for Combination Products feature:

• Added the Remedial Action (remedial_action__v) picklist with the following values:
  • Inspection (inspection__v)
  • Modification/Adjustment (modification_adjustment__v)
  • Notification (notification__v)
  • Other (remedial_action_other__v)
  • Patient Monitoring (patient_monitoring__v)
  • Recall (recall__v)
  • Relabelling (relabelling__v)
  • Repair (repair__v)
  • Replace (replace__v)
• Added the Malfunction (malfunction__v) picklist with the following values:
  • Yes (yes__v)
  • No (no__v)
• Added the following fields to the Case Product (case_product__v) object for the Device, Company Product, External Product, and Study Product object types:
  • Remedial Action (remedial_action__v)
  • Remedial Action Other (remedial_action_other__v)
  • Malfunction (malfunction__v)
• Increased the maximum length of the Serial Number (serial_number__v) field on the Case Product (case_product__v) object from 25 to 30 characters.
• Added the Device Report Type (Status) (device_report_type_status__v) field to the Case Product (case_product__v) object.

The following changes were made to support the Auto-Translation Framework for Localized Intake and Case Submissions feature:

• Added the User (user__v) field to the Automation Task (automation_task__v) object.
• Added the following fields to the Connection (connection__sys) object for the Translation Connect (translation_connection__v) type:
  • External Id (external_id__v)
  • Role Arn (role_arn__v)
  • Bucket Name (bucket_name__v)
• Added the Translation Request ID (translation_request_id__v) field to the Localized Case (localized_case__v) object.
• Added the Amazon Translate Connection (amazon_translate_connection__v).
• Added “Activate Translation Connection” record action to the Translation (translation_connection__v) Connection object type.
• Added record action to move Translation type Connections that are in the Pending state to the Active state.

The following changes were made to support the Async Submit to Gateway feature:

• Added a new record action “Async Submit to Gateway” to the Case (case__v) object.
• Added the new state type “Queued State” to all lifecycles.

The following changes were made to support fixing an issue where validations could fail without indicating an error at the Case level (fixed issue reference: SAF-34354):

• The following states were added to the Validation Status picklist on the Case object:
  • Error (error__v)
  • In Progress (in_progress__v)

The following change was made to support E2B import logic for country code aliases, for example, to import E2B cases from Northern Ireland (fixed issue reference: SAF-32724):

• The Country Code Alias (abbreviation_alias__v) field was added to the Country (country__v) object

Data Model Updates - SafetyDocs

The following changes were made to support the PSMF Automatic Logbook Generation feature:

• Added the PSMF Logbook (psmf_logbook__v) object.
• Added the PSMF Logbook Lifecycle (psmf_logbook_lifecycle__v) object lifecycle.
• Added the PSMF Logbook Entry (psmf_logbook_entry__v) object.
• Added the PSMF Logbook Entry Lifecycle (psmf_log_entry_lifecycle__v) object lifecycle.
• Added the PSMF Binder Lifecycle (psmf_binder_lifecycle__v).
• Added the PSMF Content Lifecycle (psmf_content_lifecycle__v).
• Added the PSMF Generated Document Lifecycle (psmf_generated_document_lifecycle__v).
• Added the Pharmacovigilance System Master File (pharmacovigilance_system_master_file__v) document type.
  • Added the document subtype PSMF Content (psmf_content__v) under Pharmacovigilance System Master File.
    • Added the following document classifications under Pharmacovigilance System Master File > PSMF Content:
      • PSMF Title Page (psmf_title_page__v).
      • PSMF Core Document (psmf_core_document__v).
      • PSMF Annex (psmf_annex__v).
  • Added the document subtype PSMF Generated Document (psmf_generated_document__v) under Pharmacovigilance System Master File.
    • Added the following document classifications under Pharmacovigilance System Master File > PSMF Generated Document:
      • PSMF Table of Contents (psmf_table_of_contents__v).
      • PSMF Logbook (psmf_logbook__v).
      • PSMF eSignature Page (psmf_esignature_page__v).
      • PSMF Generated PDF (psmf_generated_pdf__v).
  • Added the document subtype PSMF Binder (psmf_binder__v) under Pharmacovigilance System Master File.
    • Added the following document classifications under Pharmacovigilance System Master File > PSMF Binder:
      • PSMF Global Binder (psmf_global_binder__v).
      • PSMF Local Binder (psmf_local_binder__v).
• Added the PSMF Details field layout, along with the following fields:
  • Added the PSMF Section (psmf_section__v) field.
  • Added the PSMF Annex (psmf_annex__v) field.
  • Added the PSMF Jurisdiction (psmf_jurisdiction__v) field.
• Added the following relationship types:
  • Under Pharmacovigilance System Master File > PSMF Binder, added the Generated PSMF (generated_psmf__v) relationship type.
  • Under Pharmacovigilance System Master File > PSMF Generated Document, added the PSMF Binder (psmf_binder__v) relationship type.
• Added the following tabs under the PSMF tab:
  • PSMF Binders (psmf_binders__v).
  • PSMF Logbooks (psmf_logbooks__v).
• Added the following notification templates:
  • PSMF Merge Succeeded (psmf_merge_success__v).
  • PSMF Merge Warning (psmf_merge_warning__v).
  • PSMF Merge Failure (psmf_merge_failure__v).
• Added the following components to support PSMF logbook report generation:
  • Added the PSMF Logbook with Documents and PSMF Logbook Entry (psmf_logbook_with_documents_and_psmf__v) report type.
  • Added the PSMF Content Documents in Binder (psmf_content_documents_in_binder__v) report view.
  • Added the Logbook with Logbook Final Entries and Documents (logbook_with_logbook_entries_and_docs__v) report view.
  • Added the PSMF Binder Logbook (psmf_binder_logbook__v) multi-pass report type.
  • Added the PSMF Binder Logbook (psmf_binder_logbook__v) standard report.
• Added the Generate PSMF PDF (generate_psmf_pdf__v) document action.