24R3 Data Model Changes: Safety

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 New in 24R3 Limited Release.

24R2.2

Safety

The following changes were made to support the Sender-Based Email Inbox Item Pre-Population feature:

  • Added the following fields to the Transmission Profile (transmission_profile__v) object:
    • Pre-Populate Country (prepopulate_country__v)
    • Pre-Populate Report Type (prepopulate_report_type__v)

The following changes were made to support the Inbox Item Enhancements: Report Type & Seriousness feature:

  • Added the following fields to the Inbox Item (inbox_item__v) object:
    • Report Type (report_type__v)
    • Seriousness (seriousness__v)

The following changes were made to support the Duplicate E2B XML File Detection feature:

  • Added the Enable E2B Document Duplicate Detection (enable_document_duplicate_detection__v) picklist with the following picklist values:
    • Yes (yes__v)
    • No (no__v)
  • Added the Enable E2B Document Duplicate Detection (enable_document_duplicate_detection__v) picklist field to the Transmission Profile (transmission_profile__v) object.
  • Added the Enable E2B Document Duplicate Detection (enable_document_duplicate_detection__v) document field to the Adverse Event Report (adverse_event_report__v) document classification with the following values:
    • Yes (yes__v)
    • No (no__v)

The following change was made to support the Duplicate Inbox Item Linking feature:

  • Added the Linked Inbox Item (linked_inbox_item__v) field to the Inbox Item (inbox_item__v) object.

The following change was made to support the Configurable PII and E2B Masking for NullFlavor Fields feature:

  • Add the Null Flavors (null_flavors__v) picklist value to the Exceptions to Patient Content Protection (exceptions_to_patient_content_protection__v) picklist.

The following changes were made to support the EU Convention E2B(R2) feature:

  • Added the EU Convention E2B(R2) (eu_convention_e2br2__v) picklist value to the Document Types (document_types__v) picklist.
  • Added the EU Convention E2B(R2) (eu_convention_e2br2__v) document classification to the ICSR Individual Case Safety Reports (ICSR) (generated__v) document subtype of the Case (case__v) document type.

The following changes were made to support the MedDRA Bulk Recode Without Case Upversioning feature:

  • Added the Approved/Closed Case Bulk Action Scope (closed_case_bulk_action_scope__v) picklist with the following values:
    • All Case Versions (all_case_versions__v)
    • Latest Case Version (latest_case_version__v)
  • Added the Approved/Closed Case Bulk Action Scope (closed_case_bulk_action_scope__v) picklist field to the Dictionary Bulk Action (dictionary_bulk_action__v) object.

The following change was made to support the PMDA Post-Market Reports: Filter by Local Awareness Date feature:

  • Added the Local Awareness Date (local_awareness_date__v) picklist value to the Filter Cases By (filter_cases_by__v) picklist for the PMDA Post-Market (pmda_postmarket__v) object type of the Aggregate Report (aggregate_report__v) object.

The following changes were made to support the Additional Filters for CIOMS II Aggregate Report feature:

  • Added the following fields to the Aggregate Report (aggregate_report__v) object:
    • Case Expectedness (case_expectedness__v)
    • Case Relatedness (case_relatedness__v)
    • Case Serious (case_serious__v)
    • Expectedness Source (expectedness_source__v)
    • Original CIOMS II Logic (original_cioms_ii_logic__v)
    • Report Type (report_type__v)
  • Added the Aggregate Report Country (aggregate_report_country__v) object with the following fields:
    • Aggregate Report (aggregate_report__v)
    • Country (country__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Global ID (global_id__sys)
    • ID (id)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Lifecycle (lifecycle__v)
    • Lifecycle State (state__v)
    • Link (link__sys)
    • Name (name__v)
    • Status (status__v)
  • Added the Aggregate Report Country (aggregate_report_country_lifecycle__v) object lifecycle.

The following changes were made to support the Safety-EDC Connection: Send SAE Reporter Details to Safety feature:

  • Added the following fields to the CDMS Subject Adverse Event (cdms_subject_adverse_event__v) object:
    • Reporter City (reporter_city__v)
    • Reporter Country (reporter_country__v)
    • Reporter Email (reporter_email__v)
    • Reporter First Name (reporter_first_name__v)
    • Reporter Last Name (reporter_last_name__v)
    • Reporter Postal Code (reporter_postal_code__v)
    • Reporter Qualification (reporter_qualification__v)
    • Reporter State / Province (reporter_state_province__v)
    • Reporter Street (reporter_street__v)
    • Reporter Street 2 (reporter_street_2__v)
    • Reporter Telephone (reporter_telephone__v)
    • Reporters Comments (reporters_comments__v)

The following changes were made to support the Country Specific IMP ICSR Reporting feature:

  • Added the Study Product Country (study_product_country__v) object with the following fields:
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Global ID (global_id__sys)
    • ID (id)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Lifecycle (lifecycle__v)
    • Lifecycle Stage (stage__sys)
    • Lifecycle State (state__v)
    • Lifecycle State Stage ID (state_stage_id__sys)
    • Link (link__sys)
    • Name (name__v)
    • Status (status__v)
    • Study (study__v)
    • Study Product (study_product__v)
    • Study Product Role Override (study_product_role_override__v)
    • Study Registration (study_registration__v)
  • Added the Study Product Country Lifecycle (study_product_country_lifecycle__v) object lifecycle to the Study Product Country (study_product_country__v) object.

SafetyDocs

The following changes were made to support the Literature Coding to Product Family feature:

  • Added the Product Family (product_family__v) field to the following objects:
    • Literature Article (literature_article__v)
    • Literature Review (literature_review__v)
    • Literature Search Term (literature_search_term__v)
    • Literature Standard Search Term (literature_standard_search_term__v)

The following change was made to support the Customize Sender Email Address for PVA Document Distribution feature:

  • Added the Originating Email (originating_email__v) field to the PV Agreement (pv_agreement__v) object.

The following changes were made to support the Create Inbox Items from Literature Articles in CRO Vaults feature:

  • Added the Organization (organization__v) field to the following objects:
    • Literature Review (literature_review__v)
    • Literature Article (literature_article__v)

The following changes were made to support the Capture Additional Information for Safety Investigations feature:

  • Added the following fields to the Safety Investigation (safety_investigation__v) object:
    • Description (description__v)
    • Due Date (due_date__v)
    • Validation Outcome Rationale (validation_outcome_rationale__v)
    • Disposition Rationale (disposition_rationale__v)