22R2 Data Model Changes: Safety

Pre-Release Date: July 11, 2022 | Release Date: August 4, 2022 & August 12, 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 22R2.

For information about data model changes related to Vault Platform, see 22R2 Data Model Changes: Platform.

Data Model Updates - Safety

The following changes were made to support the Auto-Calculations: Warnings for Overridden Values feature:

  • Added the Age At Vaccination (Status) (age_at_vaccination_calculation_status__v) field to the Case Drug History (case_drug_history__v) object.
  • Added the following fields to the Case (case__v) object:
    • Age at Onset (Status) (age_calculation_status__v)
    • Age Group (Status) (age_group_calculation_status__v)
    • Age at Vaccination (Status) (age_at_vaccination_calculation_status__v)
  • Added the Duration (Status) (duration_calculation_status__v) field to the Case Adverse Event (case_adverse_event__v) object.
  • Added the Duration (Status) (duration_calculation_status__v) field to the Case Product Dosage (case_product_dosage__v) object.
  • Added the Cumulative Dose (Status) (cumulative_dose_calculation_status__v) field to the Case Product (case_product__v) object.
  • Added the following fields to the Case Assessment (case_assessment__v) object:
    • First Dose Latency (Status) (first_dose_latency_calculation_status__v)
    • Last Dose Latency (Status) (last_dose_latency_calculation_status__v)

The following changes were made to support the Blind Protection Relatedness Override - CIOMS I and E2B feature:

  • Added the Assessment Result Override (assessment_result_override__v) object type to the Controlled Vocabulary (controlled_vocabulary__v) object.
  • Added the Assessment Result Override (assessment_result_override__v) field to the Controlled Vocabulary (controlled_vocabulary__v) object.
  • Added the following Controlled Vocabulary (controlled_vocabulary__v) record with the Assessment Result Override (assessment_result_override__v) object type:
    Field Value
    Type Assessment Result Override
    Name Not Applicable
    E2B Code 2
    Assessment Result Override Not Applicable
    Causality Established No
    API assessment_result_not_applicable__v
  • Added the Assessment Result (Override) (assessment_result_override__v) field to the Case Assessment Result (case_assessment_result__v) object.

The following changes were made to support the Case Data Validations and Always Evaluate Criteria feature:

  • Added the Always Evaluate (always_evaluate__v) field to the Validation Criteria (validation_criteria__v) object.
  • Added the Rule Formula Format (rule_formula_format__v) field to the Validation Criteria (validation_criteria__v) object.
  • The File Format (file_format__v) field on the Validation Criteria (validation_criteria__v) object is no longer required.

The following changes were made to support the Combination Product FDA E2B(R2) Export and Case Processing Enhancements feature:

  • Added the Trade Name (trade_name__v) field to the Case Product (case_product__v) object.
  • Added the Product Code (product_code__v) field to the Case Product (case_product__v) object.

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

  • Added the Localization Scope (localization_scope__v) field to the Localization (localization__v) object.
  • Added the Country State / Province (country_state_province__v) object.
  • Added the Localized Country State / Province (localized_country_state_province__v) object.
  • Added the Country State/Province Lifecycle (country_state_province_lifecycle__v) object lifecycle.
  • Added the Localized Country State/Province (localized_country_state_province_lc__v) object lifecycle.
  • Added the State / Province (state_province__v) field to the Case Contact (case_contact__v) object.
  • Added the following fields to the Localized Case Contact (localized_case_contact__v) object:
    • State / Province (state_province__v)
    • Use Domestic State Code (use_domestic_state_code__v)

The following changes were made to support the EDQM Dose Forms and Routes of Administration feature:

  • Added the EDQM (edqm__v) object.
  • Added the following fields to the EDQM (edqm__v) object:
    • API Name (api_name__v)
    • EDQM Type (edqm_type__v)
    • EDQM Name (edqm_name__v)
    • EDQM Code (edqm_code__v)
    • EDQM Term Status (edqm_term_status__v)
    • EDQM Version (edqm_version__v)
    • Name (name__v)
  • Added the EDQM Mapping (edqm_mapping__v) object.
  • Added the following fields to the EDQM Mapping (edqm_mapping__v) object:
    • EDQM (edqm__v)
    • EDQM Mapping Type (object_type__v)
    • Dose Form (dose_form__v) (Dose Form object type only)
    • Route of Administration (route_of_admin__v) (Route of Administration object type only)
    • Primary for Import (primary_for_import__v)
    • Name (name__v)
  • Added the EDQM Lifecycle (edqm_lifecycle__v) object lifecycle.
  • Added the EDQM Mapping Lifecycle (edqm_mapping_lifecycle__v) object lifecycle.
  • Added the EDQM Standard Term (edqm_standard_term__v) object type to the Dictionary (dictionary__v) object.
  • Added the EDQM Standard Term (type = EDQM) object record to the Dictionary (dictionary__v) object.

The following changes were made to support the Exclude Literature for E2B Submissions feature that will be included in a future release:

  • Added the following fields to the Transmission (transmission__v) object:
    • Attachment Documents (attachment_documents__v)
    • Literature Documents (literature_documents__v)

The following changes were made to support the Field Limit Updates for E2B feature:

  • Added the Dose Text (Long Text) (dose_text_long_text__v) field to the Case Product Dosage (case_product_dosage__v) object.
  • Added the Dose Text (Long Text) (dose_text_long_text__v) field to the Localized Case Product Dosage (localized_case_product_dosage__v) object.
  • Added the Reason Text (Long Text) (reason_text_long_text__v) field to the Transmission (transmission__v) object.
  • Added the Result (Text) (result_value_text_v) field to the Case Test Result (case_test_result__v) object.

The following changes were made to support the Generate and Manage Standalone CIOMS II Line Listing feature:

  • Added the Comments Field (comments__v) field to the _Aggregate Report _(aggregate_report__v) object.
  • Added the CIOMS II (cioms_ii__v) object type to the _Aggregate Report _(aggregate_report__v) object.
  • Added the following Shared Fields to the CIOMS II document class:
    • Blind Protection (blind_protection__v)
    • Study Content Protection (study_content_protection__v)
  • Added the following new template to the CIOMS II document type:
    Field Value
    Type Basic Document Template
    Label CIOMS II Line Listing
    Name cioms_ii_line_listing__v
    Defined in Template > Aggregate Summary Tabulation > CIOMS II Line Listing
    Status Active
  • Added the following actions:
    • Create Next Aggregate Report Record
    • Generate Aggregate Report Tabulations

The following changes were made to support the Health Canada Transmission Profiles and Message Types feature:

  • Added the Message Type (HC) (message_type_hc__v) field to the Transmission (transmission__v) object (Base Transmission and Submission types only).

The following changes were made to support the Multi-Format Submissions and Distributions feature:

  • Added the Additional Outbound Format(s) (additional_outbound_formats__v) field to the Transmission Profile (transmission_profile__v) object.
  • Added the Additional Transmission Document Type(s) (additional_transmission_documents__v) field to the Transmission (transmission__v) object.
  • Converted the Outbound Transmissions (outbound_transmissions__v) document field to a Shared Field.

The following changes were made to support the Narrative Templates for Report Types and Studies feature:

  • Added the following Shared Fields to the Template > Narrative (Template) (narrative__v) document types:
    • Localization (localization__v)
    • Report Type (report_type__v)
    • Study (study__v)
    • Study Type (study_type__v)
  • Added the Narrative Template Type (narrative_template_type__v) field to the Transmission Profile (transmission_profile__v) object (AS2 Gateway and System types only).
  • Added the Connection (connection__v) object type to the Transmission Profile (transmission_profile__v) object.
  • Added the following Transmission Profiles:
    1. General API
      Field Value
      Name General API Profile
      Type Connection
      Origin vault_customer__v
      Origin ID ORIGINID
      Destination vault_customer__v
      Destination ID DESTINATIONID
      Organization vault_customer__v
      Outbound Format E2B(R3)
      Enable Auto Promote No
      Serious Merge Method Manual
      Non Serious Merge Method Manual
      Import to Inbox Yes
      API Name general_api_profile__v
    2. EDC API
      Field Value
      Name EDC API Profile
      Type Connection
      Origin vault_customer__v
      Origin ID ORIGINID
      Destination vault_customer__v
      Destination ID DESTINATIONID
      Organization vault_customer__v
      Outbound Format E2B(R3)
      Enable Auto Promote No
      Serious Merge Method Manual
      Non Serious Merge Method Manual
      Import to Inbox Yes
      API Name edc_api_profile__v

The following changes were made to support the Pagination in Dose Section Control feature:

  • Removed the Child Dosage (child_dosage_data__v) field from the Case Product (case_product__v) object.
  • Added the Session Store ID Dosage (session_store_id_dosage__v) field to the Case Product (case_product__v) object.

The following changes were made to support the Receiver Information Export for E2B(R2) and PMDA E2B(R3) feature:

  • Updated the the following existing Transmission Profile (transmission_profile__v) records with these default values:
    1. HC CVP (hc_cvp)
      Field Value
      Receiver Type 2
      Receiver Organization Canada Vigilance
      Receiver Department Marketed Products
      Receiver Address 0701E
      Receiver City Ottawa
      Receiver State Ontario
      Receiver Postal Code K1A 0K9
      Receiver Country Canada
      Receiver Telephone 6139570337
      Receiver Fax 6139570335
      Receiver Email CanadaVigilance@hc-sc.gc.ca
    2. HC TPD (hc_tpd__v)
      Field Value
      Receiver Type 2
      Receiver Organization Canada Vigilance
      Receiver Department Office of Clinical Trials
      Receiver Address 3105A
      Receiver City Ottawa
      Receiver State Ontario
      Receiver Country Canada
      Receiver Postal Code K1A 0K9
      Receiver Telephone 6139412132
      Receive Fax 6139529656
      Receiver Email OCT_BEC_Enquiries@hc-sc.gc.ca
  • Added the Receiver Person (receiver_person__v) object type to the Person (person__sys) object.
  • Added the following fields to the Receiver Person (receiver_person__v) object type:
    • Receiver Type (receiver_type__v)
    • Telephone Extension (telephone_ext__v)
    • Country Code (telephone_country__v)
    • Fax Extension (fax_ext__v)
    • Fax Country Code (fax_country__v)
    • Exclude From Receiver Block (exclude_from_receiver_block__v)
  • Added the Receiver Person (receiver_person__v) field to the Transmission Profile (transmission_profile__v) object.

The following changes were made to support the Reporting Family Jurisdictions and Distribution List Management feature:

  • Added the Distribution Jurisdiction (distribution_jurisdiction__v) object.
  • Added the Distribution Jurisdiction Lifecycle (distribution_jurisdiction_lifecycle__v) object lifecycle.

Added the following standard tabs to support Safety Suite Manifest Update and Tabs:

  • Inbox (inbox__v)
  • Cases (cases__v)
  • Localized Cases (localized_cases__v)
  • Transmissions (transmissions__v)
    • Submissions (submissions__v)
    • Distributions (distributions__v)
  • Inbound Transmissions (inbound_transmissions__v)
  • Aggregate Reports (aggregate_reports__v)
    • DSURs (dsurs__v)
    • PBRERs (pbrers__v)
    • PADER (paders__v)
    • PSURs (psurs__v)
  • Action Items (action_items__v)
  • Analytics (analytics__v)
  • PVAs (safetydocs_pva__v) (SafetyDocs)
  • PSMF (safetydocs_psmf__v) (SafetyDocs)

See Enable Safety Suite Manifest Update and Tabs for details on enabling these tabs in your Vault.

The following changes were made to support the Unconstrained UCUM for Test Result Units feature:

  • Added the Result (Unit) Text (result_unit_text__v) field to the Case Test Result (case_test_result__v) object.

The following changes were made to support the Cross Reporting Most Conservative Submission feature:

  • Added the Cross Report Priority (cross_report_priority_v) field to the Organization (organization_v) object (Agency type only).
  • Added the following picklist to the Cross Report Priority (cross_report_priority_v) field:
    • Marketing (marketing__v)
    • Investigational (investigational__v)
    • Marketing and Investigational (marketing_and_investigational__v)