Pre-Release Date: July 22, 2024 | Release Date: August 8, 2024 & August 16, 2024

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 24R2.

For information about data model changes related to Vault Platform, see 24R2 Data Model Changes: Platform.

Safety

The following changes were made to support the Sender-Based Email Attachment Handling feature:

  • Added the Email Attachment Handling Method (email_attachment_handling_method__v) picklist with the following values:
    • Separate (separate__v)
    • Single-File Import (singlefile_import__v)
    • Manual (manual__v)
  • Added the Transmission Profile Email (transmission_profile_email__v) object with the following fields:
    • 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)
    • Person (person__v)
    • Status (status__v)
    • Transmission Profile (transmission_profile__v)
  • Added the Inbound Email Profile (email_profile__v) object type to the Transmission Profile (transmission_profile__v) object.

The following change was made to support the Rule Level Control of Auto-Submit feature:

  • Added the Auto-Submit Override (auto_submit_override__v) picklist value to the Safety Rule Parameter Name (safety_rule_parameter_name__v) picklist.

The following changes were made to support the Safety-RIM Connection: PSMF Annex H Support feature:

  • Added the following picklists:
    • Additional Monitoring (additional_monitoring__v)
    • Non-Standard Aggregate Periodicity (nonstandard_aggregate_periodicity__v)
  • Added the following fields to the Product Registration (product_registration__v) object:
    • Additional Monitoring (additional_monitoring__v)
    • Application Lead Market (application_lead_market__v)
    • Application Number (application_number__v)
    • Non-Standard Aggregate Periodicity (nonstandard_aggregate_periodicity__v)
    • Procedure Type (procedure_type__v)
    • Procedure Number (procedure_number__v)

The following changes were made to support the Reporting Family Configuration Scenarios feature:

  • Added the Product Family (product_family__v) object type to the Reporting Family Member (reporting_family_member__v) object.
  • Added the Product Family (product_family__v) field to the Product Family (product_family__v) object type.
  • Added the Coded Product Registration Only (coded_product_registration_only__v) field to the Product Registration (product_registration__v) object type.
  • Added the following fields to the Partner Distribution List (partner_distribution__v) object type:
    • All Products (all_products__v)
    • All Studies (all_studies__v)
    • Distribution Substance Lookup Method (distribution_substance_lookup_method__v)

The following changes were made to support the PMDA E2B(R3): Export Substance Codes from JDrug Codes feature:

  • Added the Japan Product Code Type (japan_product_code_type__v) field to the following objects:
    • Case Product Registration (case_product_registration__v)
    • Localized Case Product (localized_case_product__v)

The following changes were made to support the Include Source Document in Email Transmission feature:

  • Added the Attach Source Document(s) (attach_source_documents__v) field to the Email Profile (email_profile__v) object type with the following picklist values:
    • Exclude Unredacted Source Documents for PII Mask (exclude_unredacted_source_documents__v)
    • Any Source Document (any_source_document__v)
  • Added the Outbound Transmissions (outbound_transmissions__v) document field to the Source (source__v) document type.

The following change was made to support the Reporting Rule Level Control of Auto-Submit for Transmissions feature:

  • Added the Auto-Submit Override (auto_submit_override__v) picklist value to the Safety Rule Parameter Name (safety_rule_parameter_name__v) picklist.

The following change was made to support the Adverse Event in Jurisdiction Parameter Country Differentiation feature:

  • Added the AE in Jurisdiction Source (ae_in_jurisdiction_source__v) picklist value to the Safety Rule Parameter Name (safety_rule_parameter_name__v) picklist.

The following changes were made to support the Automated Classification of Inbox Item Significance feature:

  • Added the Significance (significance__v) field to the Inbox Item (inbox_item__v) object with the following picklist values:
    • Initial Case (initial_case__v)
    • Non-Significant Follow Up (nonsignificant_follow_up__v)
    • Significant Follow Up (significant_follow_up__v)
    • Urgent-Significant Follow Up (urgentsignificant_follow_up__v)
  • Added the Enable Auto Significance (enable_auto_significance__v) field to the Connection (connection__v) object type on the Transmission Profile (transmission_profile__v) object with the following picklist values:
    • Yes (yes__v)
    • No (no__v)
  • Added the following lifecycle states to the Inbox Item Lifecycle (inbox_item_lifecycle__v) object lifecycle:
    • Superseded (superseded_state__v)
    • Marked as Follow-up (Not Current) (marked_as_follow_up_not_current_state__v)

The following changes were made to support the Online Questionnaires for Post-Marketing Follow-ups feature:

  • Added the Follow-up Questionnaire Rule (followup_questionnaire_rule__v) object with the following fields:
    • Days Between Attempts (days_between_attempts__v)
    • Enable Auto-Send (enable_autosend__v)
    • From (from__v)
    • Name (name__v)
    • Reply-To (replyto__v)
    • Total Attempts (total_attempts__v)
  • Added the Follow-up Rule Design (followup_rule_design__v) object with the following fields:
    • Follow-up Questionnaire Rule (followup_questionnaire_rule__v)
    • Name (name__v)
    • Questionnaire Design (questionnaire_design__v)
  • Added the Follow-up Rule Criteria (followup_rule_criteria__v) object with the following fields:
    • Field Name (field_name__v)
    • Follow-up Questionnaire Rule (followup_questionnaire_rule__v)
    • Name (name__v)
    • Object Name (object_name__v)
    • Value (value__v)
  • Added the Design Country (design_country__v) object with the following fields:
    • Country (country__v)
    • Name (name__v)
    • Questionnaire Design (questionnaire_design__v)
  • Added the Design Watchlist (design_watchlist__v) object with the following fields:
    • Name (name__v)
    • Questionnaire Design (questionnaire_design__v)
    • Watchlist (watchlist__v)
  • Added the Question Field Mapping (question_field_mapping__v) object with the following fields:
    • Field Name (field_name__v)
    • Name (name__v)
    • Object Name (object_name__v)
    • Question Design (question_design__v)
    • Questionnaire Design (questionnaire_design__v)
  • Added the Application Managed User (application_managed_user__v) object with the following fields:
    • Application User Management Type (application_user_management_type__v) with the following value:
      • PAL Follow-up Questionnaire Respondent (pal_followup_questionnaire_respondent__v)
    • Name (name__v)
    • User (user__v)
  • Added the Questionnaire PAL Context (questionnaire_pal_context__v) object with the following fields:
    • Case (case__v)
    • Follow-up Questionnaire (followup_questionnaire__v)
    • Name (name__v)
    • Public Access Link Expiration Date (pal_expiration_date__sys)
    • Public Access Link Last Accessed Date (pal_last_accessed_date__sys)
    • Public Access Link Status (pal_status__sys) with the following values:
      • Active (active__v)
      • Inactive (inactive__v)
    • Public Access Link Type (pal_type__sys)
    • Recipient (Case Contact) (recipient_case_contact__v)
  • Added the Follow-up Questionnaire Rule Lifecycle (followup_questionnaire_rule_lifecycle__v) object lifecycle.
  • Added the Follow-up Rule Design Lifecycle (followup_rule_design_lifecycle__v) object lifecycle.
  • Added the Follow-up Rule Criteria Lifecycle (followup_rule_criteria_lifecycle__v) object lifecycle.
  • Added the Design Country Lifecycle (design_country_lifecycle__v) object lifecycle.
  • Added the Design Watchlist Lifecycle (design_watchlist_lifecycle__v) object lifecycle.
  • Added the Question Field Mapping Lifecycle (question_field_mapping_lifecycle__v) object lifecycle.
  • Added the Application Managed User Lifecycle (application_managed_user_lifecycle__v) object lifecycle.
  • Added the Questionnaire PAL Context Lifecycle (questionnaire_pal_context_lifecycle__v) object lifecycle.
  • Added the Questionnaire (questionnaire__v) object type to the Transmission (transmission__v) object.
  • Added the Follow-up Questionnaire (followup_questionnaire__v) checklist type to the Transmission (transmission__v) object.
  • Added the Access Group (access_group__v) field to the Transmission Checklist (transmission_checklist__sys) object.
  • Added the following fields to the Transmission (transmission__v) object:
    • Follow-up Questionnaire Rule (followup_questionnaire_rule__v)
    • From (from__v)
    • Ready to Send (ready_to_send__v)
  • Added the PAL Follow-up Questionnaire Respondent (pal_fu_questionnaire_respondent__v) permission set.
  • Added the PAL Follow-up Questionnaire Respondent (pal_fu_questionnaire_respondent__v) security profile.

The following changes were made to support the Product Coding: Additional Matching Fields for Product Aliases feature:

  • Added the Alias Match Type (alias_match_type__v) picklist with the following picklist values:
    • Is Equal To (is_equal_to__v)
    • Is Blank (is_blank__v)
    • Is Not Blank (is_not_blank__v)
    • Matches Registration Value (matches_registration_value__v)
  • Added the following fields to the Product Alias (product_alias__v) object:
    • Country Alias Match Type (country_alias_match_type__v) with the following picklist values:
      • Is Equal To (is_equal_to__v)
      • Is Blank (is_blank__v)
      • Is Not Blank (is_not_blank__v)
      • Matches Registration Value (matches_registration_value__v)
    • Dose Form Alias Match Type (dose_form_alias_match_type__v) with the following picklist values:
      • Is Equal To (is_equal_to__v)
      • Is Blank (is_blank__v)
      • Is Not Blank (is_not_blank__v)
      • Matches Registration Value (matches_registration_value__v)
    • Dose Strength Alias Match Type (dose_strength_alias_match_type__v) with the following picklist values:
      • Is Equal To (is_equal_to__v)
      • Is Blank (is_blank__v)
      • Is Not Blank (is_not_blank__v)
      • Matches Registration Value (matches_registration_value__v)
    • Dose Strength (Unit) Alias Match Type (dose_strength_unit_alias_match_type__v) with the following picklist values:
      • Is Equal To (is_equal_to__v)
      • Is Blank (is_blank__v)
      • Is Not Blank (is_not_blank__v)
      • Matches Registration Value (matches_registration_value__v)
    • Organization Alias Match Type (organization_alias_match_type__v) with the following picklist values:
      • Is Equal To (is_equal_to__v)
      • Is Blank (is_blank__v)
      • Is Not Blank (is_not_blank__v)
      • Matches Registration Value (matches_registration_value__v)
    • ROA Alias Match Type (roa_alias_match_type__v) with the following picklist values:
      • Is Equal To (is_equal_to__v)
      • Is Blank (is_blank__v)
      • Is Not Blank (is_not_blank__v)
      • Matches Registration Value (matches_registration_value__v)
    • Country (country__v)
    • Default Alias (default_alias__v) with the following picklist values:
      • Yes (yes__v)
      • No (no__v)
    • Dose Form (dose_form__v)
    • Dose Strength (dose_strength__v)
    • Dose Strength (Unit) (dose_strength_unit__v)
    • Order (order__v)
    • Route of Administration (route_of_administration__v)
  • Added the Route of Administration (route_of_administration__vr) object relationship to the Product Alias (product_alias__v) object.

The following changes were made to support the Configurable “From” Email Address for Transmissions feature:

  • Added the From Email Person (from_email_person__v) object type to the Person (person__sys) object.
  • Added the following fields to the From Email Person (from_email_person__v) object type of the Person (person__sys) object:
    • Email (email__sys)
    • First Name (first_name__sys)
    • Language (language__sys)
    • Last Name (last_name__sys)
    • Outbound Email Status (outbound_email_status__sys) with the following picklist values:
      • Active (active__v)
      • Inactive (inactive__v)
    • Person Type (object_type__v)
  • Added the From Email Address (from_email_address__v) field to the Transmission Profile (transmission_profile__v) object.

The following changes were made to support the PMDA: Clinical Trial Development Phase 1-3 and J OID Code List Update feature:

  • Added the Phase 1/3 (phase_1_3__v) type with E2B Code (e2b_code__v) “6” to the Development Phase (development_phase__v) object type of the Controlled Vocabulary (controlled_vocabulary__v) object.
  • Added the Phase 1/3 (phase_1_3__v) picklist value to the Development Phase (development_phase__v) picklist which is used in the Development Phase (development_phase__v) field on the Study (study__v) object.

The following changes were made to support the PMDA: Blinded Study Product Reporting feature:

  • Added the Primary Blinded Investigational Product (primary_blinded_investigational_product__v) field to the Study Product Placeholder (study_product_placeholder__v) object.

The following changes were made to support the Japan Periodic Reporting: Post-Market Serious (J-PSR) feature:

  • Added the following picklist values to the Documents to Generate (documents_to_generate__v) picklist:
    • J-PSR Cumulative Tabulation of Adverse Events Form 3 (jpsr_cumulative_tabulation_of_adverse_e__v)
    • J-PSR Line Listing of Adverse Events Form 4 (jpsr_line_listing_of_adverse_events_fo__v)
  • Added the following document types to the Summary Tabulation (summary_tabulation__v) document type (Subtype):
    • J-PSR Line Listing of Adverse Events (jpsr_line_listing_of_adverse_events__v)
    • J-PSR Tabulation of Adverse Events (jpsr_tabulation_of_adverse_events__v)
  • Added the following document template types (Classification) to the Aggregate Summary Tabulation (aggregate_summary_tabulation__v) document template type (Subtype):
    • J-PSR Line Listing of Adverse Events (jpsr_line_listing_of_adverse_events__v)
    • J-PSR Tabulation of Adverse Events (jpsr_tabulation_of_adverse_events__v)
  • Added the Previous J-PSR Report (previous_jps_report__v) field to the PMDA Post-Market (pmda_postmarket__v) object type on the Aggregate Report (aggregate_report__v) object.
  • Added the Document (document__v) field to the Aggregate Report Case (aggregate_report_case__v) object with the following picklist values:
    • Interval Line Listings of Serious Adverse Reactions (line_listings_of_sar__v)
    • Cumulative Tabulation of Serious Adverse Reactions (cumulative_sar_from_trials__v)
    • Cumulative Tabulation of Serious Adverse Events (cumulative_sae_from_trials__v)
    • List of Subjects Who Died During the Reporting Period (list_subjects_died__v)
    • Cumulative ADRs from Postmarketing (cumulative_adrs_from_postmarketing__v)
    • PADER Summary ADR from Postmarketing sources (pader_summary_adr_from_postmarketing_sou__v)
    • 15 Day and Non-15 Day Summary Reports (15_day_and_non15_day_summary_reports__v)
    • PADER Interval Line Listings (pader_interval_line_listings__v)
    • Non-Primary Suspect Product Report (nonprimary_suspect_product_report__v)
    • List of Death Cases (list_of_death_cases__v)
    • CIOMS II Interval Line Listings (cioms_ii_interval_line_listings__v)
    • NUPR Line Listing Form 7-2 (nupr_line_listing_form_72__v)
    • PSUR Summary Tabulation of ADRs (psur_summary_tabulation_of_adrs__v)
    • PSUR Interval Line Listings (psur_interval_line_listings__v)
    • J-PSR Line Listing of Adverse Events Form 4 (jpsr_line_listing_of_adverse_events_fo__v)
    • J-PSR Cumulative Tabulation of Adverse Events Form 3 (jpsr_cumulative_tabulation_of_adverse_e__v)
  • Added the Aggregate Report Interval (aggregate_report_intervals__v) object with the following fields:
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Current Aggregate Report (current_aggregate_report__v)
    • Current Interval (current_interval__v)
    • Global ID (global_id__sys)
    • ID (id)
    • Interval End Date (interval_end_date__v)
    • Interval Start Date (interval_start_date__v)
    • 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)
    • Previous Aggregate Report (previous_aggregate_report__v)
    • Status (status__v)
  • Added the Aggregate Report Intervals (aggregate_report_intervals_lifecycle__v) object lifecycle to the Aggregate Report Interval (aggregate_report_intervals__v) object.

The following changes were made to support the AS2 Connection: Troubleshooting Tools feature:

  • Added the Test Transmission (test_transmission__v) object type to the Transmission (transmission__v) object with the following fields:
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Destination (destination__v)
    • Destination Case ID (destination_case_id__v)
    • E2B Message ID (e2b_message_id__v)
    • File (e2b_message_id__v)
    • File (unbound) (e2b_message_id__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)
    • Most Recent Response (most_recent_response__v)
    • Name (name__v)
    • Organization (organization__v)
    • Origin (origin__v)
    • Sender (User) (sender_user__v)
    • Status (status__v)
    • Submission Method (submission_method__v)
    • Transmission Date (transmission_date__v)
    • Transmission Profile (transmission_profile__v)
    • Transmission Type (object_type__v)
    • Transmission Unique Number (transmission_unique_number__v)

The following changes were made to support the AS2 Connections: Korea (MFDS) feature:

  • Added the AS2 Vault Domain / IP Configuration (as2_vault_domain_ip_configuration__v) picklist with the following picklist values:
    • AS2 Vault URL: Domain Name (typical) (as2_vault_url_domain_name__v)
    • AS2 Vault URL: Domain Name bound to static IP addresses (as2_vault_url_domain_name_static_ip__v)
    • AS2 Vault URL: IP URL (uncommon) (as2_vault_url_ip_url__v)
  • Added the AS2 Vault Domain / IP Configuration (as2_vault_domain_ip_configuration__v) picklist to the AS2 (as2__v) object type Connection (connection__sys) object.
  • Added the AS2 Ingress IPs (as2_ingress_ips__v) field to the AS2 (as2__v) object type of the Connection (connection__sys) object.

The following changes were made to support the Product Family Rule Parameter feature:

  • Added the Product Family (product_family__v) picklist value to the Safety Rule Parameter Name (safety_rule_parameter_name__v) picklist.
  • Added the API Name (api_name__v) field to the Product Family (product_family__v) object.

The following changes were made to support the Downgrade/Upgrade Scenario Evaluation feature:

  • Added the following picklist values to the Safety Rule Parameter Name (safety_rule_parameter_name__v) picklist:
    • Upgrade Scenario (upgrade_scenario__v)
    • Downgrade Scenario (downgrade_scenario__v)

The following changes were made to support the Transmission Output Templates feature:

  • Added the Transmission Output Template (transmission_output_template__v) object with the following fields:
    • API Name (api_name__v)
    • Auto-Submit (auto_submit__v)
    • Local Expedited Criteria (case_expedited__v)
    • Due in Days (due_in_days__v)
    • Exceptions to Patient Content Protection (exceptions_to_patient_content_protection__v)
    • Patient Content Protection (patient_content_protection__v)
    • Study Content Protection (study_content_protection__v)
    • Transmission Profile (transmission_profile__v)
    • Transmission Type (transmission_type__v) picklist with the following picklist values:
      • Submission (submission__v)
      • Distribution (distribution__v)
  • Added the Transmission Output Template Lifecycle (transmission_output_template_lifecycle__v) object lifecycle.
  • Added the Transmission Output Template (transmission_output_template__v) picklist value to the Safety Rule Parameter Name (safety_rule_parameter_name__v) picklist.

The following change was made to support the Safety-EDC Connection: Support Case & Subject Deletion Scenarios from EDC feature:

  • Added the EDC Reason (edc_reason__v) field to the Inbox Item (inbox_item__v) object.

The following change was made to support the Case Version Compare with Summary feature:

  • Added the Case Version Compare (case_version_compare__v) page.

The following changes were made to support the Product Browser for Faster Case Product Selection feature:

  • Added the Case Products (case_product_section_control__c) control section to the Case (case_version__v) object.
  • Added the following control fields to the Base Case Product (base__v) object type on the Case Product (case_product__v) object:
    • Product (case_product_browser_base__c)
    • JDrug (case_product_jdrug_base__c)
  • Added the Product (case_product_browser_base__c) control field to the Company Product (company_product__v) object type on the Case Product (case_product__v) object.

The following changes were made to support the Agency-Based Auto-Expectedness for Clinical Trial Study Cases feature:

  • Added the CT Expectedness Based On (ct_expectedness_based_on__v) picklist with the following values:
    • Onset Date (onset_date__v)
    • New Info Date (new_info_date__v)
  • Added the Base Clinical Trial Expectedness On (base_clinical_trial_expectedness_on__v) field to the Agency (agency__v) object type on the Organization (organization__v) object.

The following change was made to support the Show Calculation Basis for Clinical Trial Study Expectedness feature:

  • Added the Based On (based_on__v) field to the Case Assessment Expectedness (case_assessment_expectedness__v) object.

Additional Data Model Updates

The following additional changes were made:

  • Increased the maximum number of custom validation rules for the Safety System Setting max_custom_validation_rules__v from 50 to 1,000.
  • Increased the maximum length of the following fields from 250 to 1,500 characters:
    • Product (Coded) (product_name__v) field on the Localized Case Product (localized_case_product__v) object
    • Drug (Coded) (product_name__v) field on the Case Drug History (case_drug_history__v) object
    • Drug (Coded) (product_name__v) field on the Localized Case Drug History (localized_case_drug_history__v) object

SafetyDocs

The following changes were made to support the Signal Management Disposition and Reporting Period Changes feature:

  • Added the Priority (safety_investigation_priority__v) picklist to the Safety Investigation (safety_investigation__v) object with the following values:
    • Critical (critical__v)
    • High (high__v)
    • Medium (medium__v)
    • Low (low__v)
  • Added the Monitoring (monitoring_state__v) state to the Product-Event Disposition Lifecycle (product_event_disposition_lifecycle__v) object lifecycle.
  • Added the Signal Reporting Period Checklists (signal_reporting_period_checklists__v) checklist type.
  • Added the Safety Investigations Checklists (safety_investigation_checklists__v) checklist type.
  • Updated the Safety Investigation Reporting Period (safety_investigation_reporting_period__v) object label to Signal Reporting Period (safety_investigation_reporting_period__v).
  • Updated the Safety Investigation Reporting Period Lifecycle (safety_investigation_reporting_period__v) object lifecycle label to Signal Reporting Period Lifecycle (safety_investigation_reporting_period__v).
  • Updated the Refuted (refuted__v) picklist value to Non-Validated (non_validated__v) on the Validation Outcome (validation_outcome__v) picklist.
  • Inactivated the Reporting Period (reporting_period__v) field on the Safety Investigation (safety_investigation__v) object.

The following changes were made to support the Code Product-Event Combinations to MedDRA Queries feature:

  • Added the MedDRA Query (meddra_query__v) field to the following objects:
    • Product-Event Combination (product_event_combination__v)
    • Product-Event Disposition (product_event_disposition__v)
  • Updated the Primary MedDRA Term (primary_meddra_term__v) field on the Product-Event Combination (product_event_combination__v) object to not be required.

The following changes were made to support SafetyDocs Standardization 24R2:

  • Added the Contact Communication Method (contact_communication_method__v) field to the PVA Action Item (pva_action_item__v) object.
  • Added the following layouts:
    • PSMF Logbook Detail Page Layout (psmf_logbook_page_layout__v)
    • PSMF Logbook Entry Detail Page Layout (psmf_logbook_entry_page_layout__v)
    • PSMF Periodic Review Detail Page Layout (psmf_periodic_review_page_layout__v)
    • PSMF Document Review Detail Page Layout (psmf_document_review_page_layout__v)
    • Literature Article Detail Page Layout (literature_article_detail_layout__v) with the following layout rules:
      • Non-English Abstracts (nonenglish_abstracts__v)
      • No Confirmed ICSRs (no_confirmed_icsrs__v)
      • Non-Duplicate (non_duplicate__v)
    • Literature Author Detail Page Layout (literature_author_detail_layout__v)
    • Literature Additional Info Detail Page Layout (literature_additional_info_layout__v)
    • Literature Database Detail Page Layout (literature_database_detail_layout__v)
    • Literature Review Detail Page Layout (literature_review_detail_layout__v)
    • Literature Abstract Translation Detail Page Layout (literature_abstract_translation_layout__v)
    • Literature Search Term Detail Page Layout (literature_search_term_detail_layout__v) with the Non-JAPIC (non_japic__v) layout rule
    • Literature Standard Search Term Detail Page Layout (literature_standard_search_term_layout__v) with the following layout rules:
      • Non-JAPIC (non_japic__v)
      • JAPIC (japic__v)
    • PV Agreement Detail Page Layout (pv_agreement_detail_layout__v)
    • PVA Activity Detail Page Layout (pva_activity_detail_layout__v) with the following layout rules:
      • Inbound Activity (inbound_activity__v)
      • Outbound Activity (outbound_activity__v)
      • Non-email Outbound (nonemail_outbound__v)
      • Email Outbound (email_outbound__v)
      • Non-Vault Task Outbound (nonvault_task_outbound__v)
    • PVA Action Item Detail Page Layout (pva_action_item_detail_layout__v) with the following layout rules:
      • Inbound Activity (inbound_activity__v)
      • Non-email Outbound (nonemail_outbound__v)
      • Email Outbound (email_outbound__v)
      • Non-Vault Task Outbound (nonvault_task_outbound__v)
    • PVA Contact Detail Page Layout (pva_contact_detail_layout__v)
    • PVA Document Distribution Event Detail Page Layout (pva_document_distribution_event_layout__v)
    • PVA Document for Distribution Detail Page Layout (pva_document_for_distribution_layout__v) with the Hide Help Message (hide_help_message__v) layout rule
    • PVA Obligation Detail Page Layout (pva_obligation_detail_layout__v)
    • PVA Reconciliation Detail Page Layout (pva_reconciliation_detail_layout__v)
    • Relationship Detail Page Layout (relationship_detail_page_layout__v)
    • PVA-Country Detail Page Layout (pvacountry_detail_page__v)
    • PVA-Product Detail Page Layout (pvaproduct_detail_layout__v)
    • PVA-Study Detail Page Layout (pvastudy_detail_layout__v)
    • Aggregate Report Page Layout (aggregate_report_page_layout__v)
    • Aggregate Report Destination Page Layout (aggregate_report_destination_page_layout__v)
    • Aggregate Report Section Page Layout (aggregate_report_section_page_layout__v)
    • Base Aggregate Report Template Page Layout (base_aggregate_report_template_layout__v)
    • Global Aggregate Report Template Page Layout (global_aggregate_report_template_layout__v)
    • Local Aggregate Report Template Page Layout (local_aggregate_report_template_layout__v)
    • Aggregate Report Template Item Page Layout (aggregate_report_template_item_layout__v)
    • Product-Event Combination Detail Page Layout (product_event_combination_detail_pl__v)
    • Product-Event Disposition Detail Page Layout (product_event_disposition_detail_pl__v)
    • Safety Investigation Detail Page Layout (safety_investigation_detail_pl__v)
    • Signal Reporting Period Detail Page Layout (signal_reporting_period_detail_pl__v)
  • Added the SafetyDocs (safetydocs__v) tab collection with the following standard tabs:
    • Aggregate Reports (aggregate_reports__v)
    • Analytics (analytics__v)
    • Home (home__v)
    • Library (library__v)
    • Literature (literature__v)
    • PSMF (psmf__v)
    • PVAs (pvas__v)
  • Added the Signal Management (signal_management__v) tab collection with the following standard tabs:
    • Home (home__v)
    • Reporting Periods (reporting_periods__v)
    • Product-Events (product_events__v)
    • Safety Investigations (safety_investigations__v)
    • Library (library__v)
    • Analytics (analytics__v)
  • Added the following standard tabs:
    • Reporting Periods (reporting_periods__v)
    • Product-Events (product_event_combinations__v)
    • Safety Investigations (safety_investigations__v)
  • Added the following subtabs to the PSMF (safetydocs_psmf__v) tab:
    • Generated PSMFs (safetydocs_generated_psmfs__v)
    • PSMF Content (safetydocs_psmf_content__v)
  • Added the following permission sets:
    • Aggregate Report Writer (aggregate_writer_actions__v)
    • Literature Actions (literature_actions__v)
    • PSMF Contributor Actions (psmf_contributor_actions__v)
    • PSMF Coordination Actions (psmf_coordinator_actions__v)
    • PVA Actions (pva_actions__v)
    • PVA Recipient Actions (pva_recipient_actions__v)
    • Signal Management (signal_management_actions__v)
  • Added the following security profiles:
    • All SafetyDocs (all_safetydocs__v)
    • Literature (literature__v)
    • PSMF Contributor (psmf_contributor__v)
    • PSMF Coordinator (psmf_coordinator__v)
    • PVA Management (pva_management__v)
    • PVA Recipient (External) (pva_recipient__v)
    • Aggregate Report Writer (aggregate_report_writer__v)
    • Signal Management (signal_management__v)
  • Added the following notification templates:
    • PVA Activity Document Receipt (pva_activity_document_receipt__v)
    • PVA Action Item Document Receipt (pva_action_item_document_receipt__v)
  • Added the following states to the General Document Lifecycle (general_document_lifecycle__v) document lifecycle:
    • In Approval (in_approval__v)
    • Obsolete (obsolete__v)
    • Ready for Approval (ready_for_approval__v)
    • Ready for Review (ready_for_review__v)
    • In Authoring (in_authoring__v)
  • Added the following states to the PSMF Content Lifecycle (psmf_content_lifecycle__v) document lifecycle:
    • Obsolete (obsolete__v)
    • In Obsoletion (in_obsoletion__v)
    • Ready for Approval (ready_for_approval__v)
  • Added the following states to the PSMF Generated Document Lifecycle (psmf_generated_document_lifecycle__v) document lifecycle:
    • Superseded (superseded__v)
    • Rejected (rejected__v)
  • Added the following states to the PVA Lifecycle (pva_lifecycle__v) document lifecycle:
    • Draft (draft_state__v)
    • In Authoring (in_authoring__v)
    • Ready for Review (ready_for_review_state__v)
    • In Review (in_review_state__v)
    • Ready for Approval (ready_for_approval_state__v)
    • In Approval (in_approval__v)
    • Approved (approved__v)
    • Effective (effective__v)
    • Superseded (superseded__v)
    • Terminated (terminated__v)
  • Added the following states to the General Document Lifecycle (general_document_lifecycle__v) document lifecycle:
    • In Approval (in_approval__v)
    • Obsolete (obsolete__v)
    • Ready for Approval (ready_for_approval__v)
    • Ready for Review (ready_for_review__v)
    • In Authoring (in_authoring__v)
  • Added the Superseded (superseded__v) state to the Aggregate Report (aggregate_report__v) document lifecycle.
  • Added the following document types:
    • PSMF Template (psmf_template__v)
      • PSMF Annex Template (psmf__annex_template__v)
      • PSMF Core Template (psmf__core_template__v)

The following changes were made to support the JAPIC Literature Intake feature:

  • Added the following fields to the Literature Database (literature_database__v) object:
    • API Name (api_name__v)
    • Description (description__v)
  • Added the JAPIC (japic__v) record to the Literature Database (literature_database__v) object.
  • Added the Literature Standard Search Term (literature_standard_search_term__v) object with the following fields:
    • Search Database (search_database__v)
    • Product (product__v)
    • Search Term (search_term__v)
    • Search Expression Number (search_expression_number__v)
  • Added the Literature Standard Search Term (literature_standard_search_term_lifecyl__v) object lifecycle with the following states:
    • Active (active__v)
    • Inactive (inactive__v)
  • Added the following fields to the Literature Search Term (literature_search_term__v) object:
    • Standard Search Term (standard_search_term__v)
    • Product (product__v)
    • Search Expression Number (search_expression_number__v)
    • JAPIC Password (japic_password__v)
  • Updated the Search Term (search_term__v) field on the Literature Search Term (literature_search_term__v) object to not be required.
  • Added the following fields to the Literature Article (literature_article__v) object:
    • Special Report Classification Outcome (special_report_classification_outcome__v) with the following picklist values:
      • Safety Measure Report (safety_measure_report__v)
      • Research Report (research_report__v)
    • Search Expression Number (search_expression_number__v)
    • Document Number (document_number__v)
    • Institution (institution__v)
    • Conference (conference__v)
    • Duplicate Literature Review (duplicate_literature_review__v)
    • Duplicate Literature Article (duplicate_literature_article__v)
    • Primary Author Country (primary_author_country__v)
  • Added the Duplicate (duplicate__v) state to the Literature Article Lifecycle (literature_article_lifecycle__v) object lifecycle.
  • Updated the Literature Article (literature_article__v) document field to support selecting multiple values.

The following changes were made to support the Risk Management feature:

  • Added the Core Risk Management Plan (core_rmp__v) object with the following fields:
    • Product (product__v)
    • Product Family (product_family__v)
    • Substance (substance__v)
    • Product Launch Date (product_launch_date__v)
    • Effective Version (effective_version__v)
  • Added the Core RMP Lifecycle (core_rmp_lifecycle__v) object lifecycle with the following states:
    • Planned (planned_state__v)
    • Effective (effective_state__v)
    • Historical (historical_state__v)
    • Inactive (inactive_state__v)
  • Added the Core Risk Management Plan Version (core_rmp_version__v) object with the following fields:
    • Core Risk Management Plan (core_rmp__v)
    • Product (product__v)
    • Product Family (product_family__v)
    • Version (version__v)
    • Data Lock Point (data_lock_point__v)
    • Effective Date (effective_date__v)
    • Based On (based_on__v)
    • Rationale for Latest Version (rationale_for_latest_version__v)
    • Summary of Significant Changes (summary_of_significant_changes__v)
  • Added the Core RMP Version Lifecycle (core_rmp_version_lifecycle__v) object lifecycle with the following states:
    • Planned (planned_state__v)
    • Complete (complete_state__v)
    • Obsolete (obsolete_state__v)
    • Inactive (inactive_state__v)
  • Added the RMP Risk (rmp_risk__v) object with the following fields:
    • RMP Version (rmp_version__v)
    • Risk Category (risk_category__v) with the following picklist values:
      • Identified Risk (identified_risk__v)
      • Potential Risk (potential_risk__v)
      • Missing Information (missing_information__v)
    • Risk Sub-Category (risk_sub_category__v) with the following picklist values:
      • Potential harm from overdose (potential_harm_from_overdose__v)
      • Potential for risks resulting from medication errors (potential_for_risks_resulting_from_medic__v)
      • Potential for transmission of infectious agents (potential_for_transmission_of_infectious__v)
      • Potential for off-label use (potential_for_offlabel_use__v)
      • Risk common to other members of the pharmacological class (risk_common_to_other_members_of_the_phar__v)
      • Potential pharmacokinetic and pharmacodynamic interactions (potential_pharmacokinetic_and_pharmacody__v)
      • Pregnant and lactating women (pregnant_and_lactating_women__v)
      • Effect on fertility (effect_on_fertility__v)
      • Risks associated with disposal (risks_associated_with_disposal__v)
      • Risks related to the administration procedure (risks_related_to_the_administration_proc__v)
      • Paediatric safety issues (paediatric_safety_issues__v)
    • MedDRA (meddra__v)
    • MedDRA Query (meddra_query__v)
    • Risk Description (risk_description__v)
    • Risk Seriousness (risk_seriousness__v)
    • Risk Frequency (risk_frequency__v)
    • Risk-Benefit Impact (risk_benefit_impact__v)
  • Added the RMP Risk Lifecycle (core_rmp_version_lifecycle__v) object lifecycle with the following states:
    • Active (active_state__v)
    • Inactive (inactive_state__v)
  • Added the Local Risk Management Plan (local_rmp__v) object with the following fields:
    • Core Risk Management Plan (core_rmp__v)
    • Product (product__v)
    • Product Family (product_family__v)
    • Substance (substance__v)
    • Product Launch Date (product_launch_date__v)
    • Effective Version (effective_version__v)
    • Market (market__v)
    • Local Launch Date (local_launch_date__v)
  • Added the Local RMP Lifecycle (local_rmp_lifecycle__v) object lifecycle with the following states:
    • Planned (planned_state__v)
    • Effective (effective_state__v)
    • Historical (historical_state__v)
    • Inactive (inactive_state__v)
    • Not Applicable (not_applicable_state__v)
  • Added the Local Risk Management Plan Version (local_rmp_version__v) object with the following fields:
    • Local Risk Management Plan (local_rmp__v)
    • Core Risk Management Plan (core_rmp__v)
    • Core Risk Management Plan Version (core_rmp_version__v)
    • Market (market__v)
    • Product (product__v)
    • Product Family (product_family__v)
    • Version (version__v)
    • Data Lock Point (data_lock_point__v)
    • Effective Date (effective_date__v)
    • Rationale for Latest Version (rationale_for_latest_version__v)
    • Summary of Significant Changes (summary_of_significant_changes__v)
  • Added the Local RMP Version Lifecycle (local_rmp_version_lifecycle__v) object lifecycle with the following states:
    • Planned (planned_state__v)
    • In Progress (in_progress_state__v)
    • Complete (complete_state__v)
    • Obsolete (obsolete_state__v)
    • Inactive (inactive_state__v)
    • Not Applicable (not_applicable_state__v)
  • Added the Local RMP Risk (local_rmp_risk__v) object with the following fields:
    • Local Risk Management Plan Version (local_rmp_version__v)
    • Core Risk Management Plan Version (core_rmp_version__v)
    • Core Risk (core_risk__v)
    • Risk Category (risk_category__v) with the following picklist values:
      • Identified Risk (identified_risk__v)
      • Potential Risk (potential_risk__v)
      • Missing Information (missing_information__v)
    • Risk Sub-Category (risk_sub_category__v) with the following picklist values:
      • Potential harm from overdose (potential_harm_from_overdose__v)
      • Potential for risks resulting from medication errors (potential_for_risks_resulting_from_medic__v)
      • Potential for transmission of infectious agents (potential_for_transmission_of_infectious__v)
      • Potential for off-label use (potential_for_offlabel_use__v)
      • Risk common to other members of the pharmacological class (risk_common_to_other_members_of_the_phar__v)
      • Potential pharmacokinetic and pharmacodynamic interactions (potential_pharmacokinetic_and_pharmacody__v)
      • Pregnant and lactating women (pregnant_and_lactating_women__v)
      • Effect on fertility (effect_on_fertility__v)
      • Risks associated with disposal (risks_associated_with_disposal__v)
      • Risks related to the administration procedure (risks_related_to_the_administration_proc__v)
      • Paediatric safety issues (paediatric_safety_issues__v)
    • MedDRA (meddra__v)
    • MedDRA Query (meddra_query__v)
    • Risk Description (risk_description__v)
    • Risk Seriousness (risk_seriousness__v)
    • Risk Frequency (risk_frequency__v)
    • Risk-Benefit Impact (risk_benefit_impact__v)
  • Added the Local Risk Lifecycle (local_risk_lifecycle__v) object lifecycle with the following states:
    • Active (active_state__v)
    • Inactive (inactive_state__v)
  • Added the RMP Risk Measure (rmp_risk_measure__v) object with the following fields:
    • RMP (rmp__v)
    • RMP Version (rmp_version__v)
    • Based On (based_on__v)
    • Version (version__v)
    • Local RMP (local_rmp__v)
    • Local RMP Version (local_rmp_version__v)
    • Core Risk Measure (core_risk_measure__v)
    • Market (market__v)
    • Minimized Local Risk (minimized_local_risk__v)
    • Minimized Risk (minimized_risk__v)
    • Indication (indication__v)
    • Routine/Additional (routine_additional__v) with the following picklist values:
      • Routine (routine__v)
      • Additional (additional__v)
    • Measure Category (measure_category__v) with the following picklist values:
      • Summary of Product Characteristics (summary_of_product_characteristics__v)
      • Labeling (labeling__v)
      • Package Leaflet (package_leaflet__v)
      • Pack Size (pack_size__v)
      • Legal Status of Product (legal_status_of_product__v)
      • Educational Materials (educational_materials__v)
      • Direct Healthcare Professional Communications (direct_healthcare_professional_communica__v)
      • Pregnancy Prevention Programmes (pregnancy_prevention_programmes__v)
      • Controlled Access Programmes (controlled_access_programmes__v)
    • Measure Sub-Category (measure_sub_category__v) with the following picklist values:
      • Guides for patients or healthcare professionals for risk minimisation (guides_for_patients_or_healthcare_profes__v)
      • Healthcare professional checklists for risk minimization (healthcare_professional_checklists_for_r__v)
      • Risk awareness forms (risk_awareness_forms__v)
      • Demonstration kits (demonstration_kits__v)
      • Patient diaries for risk minimisation (patient_diaries_for_risk_minimisation__v)
      • Patient cards (patient_cards__v)
      • Controlled prescription and supply system (controlled_prescription_and_supply_syste__v)
      • Center accreditation systems (center_accreditation_systems__v)
      • Forms for patient information exchange between prescriber and dispenser (forms_for_patient_information_exchange_b__v)
      • Dispensing forms (dispensing_forms__v)
  • Added the RMP Risk Measure Lifecycle (rmp_risk_measure_lifecycle__v) object lifecycle with the following states:
    • Planned (planned_state__v)
    • In Progress (in_progress_state__v)
    • Complete (complete_state__v)
    • Obsolete (obsolete_state__v)
    • Inactive (inactive_state__v)
  • Added the RMP Risk Measure Tracking (rmp_risk_measure_tracking__v) object with the following fields:
    • Risk Measure (risk_measure__v)
    • Target Date (target_date__v)
    • Target Value (target_value__v)
    • Channel (channel_text__v)
    • Actual Date (actual_date__v)
    • Actual Value (actual_value__v)
    • Outcome Verdict (outcome_verdict__v) with the following picklist values:
      • Target Met (target_met__v)
      • Target Missed (target_missed__v)
      • Target Cancelled (target_cancelled__v)
  • Added the RMP Risk Measure Tracking Lifecycle (rmp_risk_measure_tracking_lifecycle__v) object lifecycle with the following states:
    • Targetted (targetted_state__v)
    • Complete (complete_state__v)
    • Cancelled (cancelled_state__v)
    • Inactive (inactive_state__v)
  • Added the Risk Management (risk_management__v) document type with the following subtypes:
    • Risk Management Plan (risk_management_plan__v) with the following classifications:
      • Core RMP (core_rmp__v) with the following fields:
        • Core Risk Management Plan (core_risk_management_plan__v)
        • Core RMP Version (core_rmp_version__v)
        • Master or Working (master_or_working__v)
      • Local RMP (local_rmp__v) with the following fields:
        • Local Risk Management Plan (local_risk_management_plan__v)
        • Local RMP Version (local_rmp_version__v)
    • Risk Measure (risk_measure__v) with the following classifications:
      • Risk Measure Tool (risk_measure_tool__v) with the following field:
        • Risk Measure (risk_measure__v)
        • Master or Working (master_or_working__v)
      • Implementation Plan (implementation_plan__v)
      • Measure Outcome (measure_outcome__v)
  • Added the Market (market__v) field to the Risk Management (risk_management__v) document type.
  • Added the Master Risk Lifecycle (master_risk_lifecycle__v) document lifecycle with the following states:
    • Planned (planned_state__v)
    • Draft (draft_state__v)
    • In Authoring (in_authoring_state__v)
    • In Review (in_review_state__v)
    • Reviewed (reviewed_state__v)
    • In Approval (in_approval_state__v)
    • Internally Approved (internally_approved_state__v)
    • Approved for Use (approved_for_use_state__v)
    • Current in Use (current_in_use_state__v)
    • Superseded (superseded_state__v)
    • Historical (historical_state__v)
  • Added the following notification templates to the Core Risk Management Plan Version (core_rmp_version__v) object:
    • RMP Version Creation Success (rmp_version_creation_success__v)
    • RMP Version Creation Failure (rmp_version_creation_failure__v)
    • Local RMP Creation Success (local_rmp_creation_success__v)
    • Local RMP Creation Failure (local_rmp_creation_failure__v)

The following changes were made to support the Generate Final Aggregate Report ZIP feature:

  • Added the Aggregate Report ZIP Generation (aggregate_report_zip_generation__v) notification template to the Aggregate Report Destination (aggregate_report_destination__v) object.
  • Added the Masked (masked__v) field to the Partner Distribution (partner_distribution__v) object type of the Aggregate Report Destination (aggregate_report_destination__v) object.

The following changes were made to support the Partner Distribution Tracking for Aggregate Reports feature:

  • Added the Partner Distribution (partner_distribution__v) object type to the Aggregate Report Destination (aggregate_report_destination__v) object with the following fields:
    • Aggregate Report (aggregate_report__v)
    • Aggregate Report Type (aggregate_report_type__v)
    • Applicable Market (applicable_market__v)
    • Destination Organization (health_authority__v)
    • Planned Submission Date (planned_submission_date__v)
    • Actual Submission Date (actual_submission_date__v)
    • PV Agreement (pv_agreement__v)
    • PVA Activity (pva_activity__v)
  • Added the Health Authority Submission (health_authority_submission__v) object type to the Aggregate Report Destination (aggregate_report_destination__v) object with the following fields:
    • Aggregate Report (aggregate_report__v)
    • Aggregate Report Type (aggregate_report_type__v)
    • Destination Organization (health_authority__v)
    • Planned Submission Date (planned_submission_date__v)
    • Actual Submission Date (actual_submission_date__v)
    • Health Authority Decision Date (health_authority_decision_date__v)
    • Health Authority Received Date (health_authority_approval_date__v)
  • Updated the Applicable Market (applicable_market__v) field on the Aggregate Report Destination (aggregate_report_destination__v) object to not be required for the Base (base__v) and Partner Distribution (partner_distribution__v) object types.