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 19R3.
Note: This page does not document base object types or standard vault fields.
PADER Aggregate Reports
The 19R3 data model includes the following changes to support generating and authoring Periodic Adverse Drug Experience Reports (PADER).
Aggregate Report Object Changes
The Aggregate Report (aggregate_report__v) object now includes the PADER (pader__v) object type.
Controlled Vocabulary Object Changes
Object Types
The Controlled Vocabulary (controlled_vocabulary__v) object now includes the Case Assessment Result (case_assessment_result__v) object type.
Fields
The Controlled Vocabulary object now includes the following fields:
| Field Label | Field Name |
|---|---|
| Causality Established | causality_established__v |
| Solicited Report | solicited_report__v |
Case Assessment Result Object Changes
The Case Assessment Result (case_assessment_result__v) object now includes the following fields:
| Field Label | Field Name |
|---|---|
| Assessment Result | assessment_result__v |
| Causality Established | causality_established__v |
EMA Submissions
The 19R3 data model includes changes to support submissions to the European Medicine Agency (EMA) EudraVigilance Gateway.
Controlled Vocabulary Object Changes
Object Types
The Controlled Vocabulary (controlled_vocabulary__v) object now includes the following object types:
| Object Type Label | Object Type Name |
|---|---|
| Case Assessment Method | case_assessment_method__v |
| Case Assessment Source | case_assessment_result__v |
Fields
The Controlled Vocabulary object now includes the following fields:
| Field Label | Field Name |
|---|---|
| Assessment Result | assessment_result__v |
| Method of Assessment | method_of_assessment__v |
| Source Type | source_type__v |
| Causality Established | causality_established__v |
| Case Assessment Source | case_assessment_source__v |
Case Assessment Result Object Changes
The Case Assessment Result (case_assessment_result__v) object now includes the following fields:
| Field Label | Field Name |
|---|---|
| Assessment Result | assessment_result__v |
| Method of Assessment | method_of_assessment__v |
| Source Type | source_type__v |
Transmission Message Object Changes
The Transmission Message (transmission_message__v) object now includes the Message Integrity Check (message_integrity_check__v) field.
CTCAE Grades
The 19R3 data model includes changes to support entering CTCAE grades.
Case Adverse Event Object Changes
The Case Adverse Event (case_adverse_event__v) object now includes the CTCAE Grade (ctcae_grade__v)field.
Case Information Ranking
The Rank (rank__v) field has been added to the following objects to enable the case information ranking feature:
- Case Adverse Event (
case_adverse_event__v) - Case Product (
case_product__v) - Case Contact (
case_contact__v) - Case Assessment (
case_assessment__v)
Designated Medical Events
The 19R3 Data Model includes changes to support Designated Medical Events (DME).
New Watchlist Object
The Watchlist (watchlist__v) object includes the following fields:
| Field Label | Field Name |
|---|---|
| Expedited | expedited__c |
| MedDRA Version | meddra_version__v |
| Organization | organization__v |
| Product | product__c |
| Study | study__c |
| Watchlist Tag | watchlist_tags__c |
New MedDRA Criteria Object
Object Types
The MedDRA Criteria (meddra_criteria__v) object includes the Watchlist Criteria (watchlist_criteria__v) object type for designated medical events.
Fields
The MedDRA Criteria object includes the Watchlist (watchlist__v) field for designated medical events.
Auto-Expectedness
The 19R3 Data Model includes the following changes to support auto-expectedness.
New MedDRA Criteria Object
Object Types
The MedDRA Criteria (meddra_criteria__v) object includes the Datasheet Criteria (datasheet_criteria__v) object type for auto-expectedness.
Object Fields
The MedDRA Criteria object includes the following fields for auto-expectedness:
| Field Label | Field Name |
|---|---|
| Datasheet | datasheet__v |
| Include Lower Levels | include_lower_levels__v |
| MedDRA Term | meddra__v |
| Medical Condition | medical_condition__v |
| MedDRA Criteria Type | object_type__v |
| Organization | organization__v |
New Datasheet Object
The Datasheet (datasheet__v) object includes the following fields:
| Field Label | Field Name |
|---|---|
| Core | core__v |
| Core Datasheet | core_datasheet__v |
| Country | country__v |
| Label/Brochure | datasheet_document__v |
| Label/Brochure (unbound) | labelbrochure_unbound__v |
| MedDRA Version | meddra_version__v |
| Organization | organization__v |
New Case Assessment Expectedness Object
The Case Assessment Expectedness (case_assessment_expectedness__v) object includes the following fields:
| Field Label | Field Name |
|---|---|
| Blind Protection | blind_protection__v |
| Case Assessment | case_assessment__v |
| Case | case_version__v |
| Country | country__v |
| Datasheet | datasheet__v |
| Datasheet Document | datasheet_document__v |
| Datasheet Document (unbound) | datasheet_document_unbound__v |
| Expected | expected__v |
| Organization | organization__v |
Case Object Changes
The Case (case_version__v) object now includes the Expected (status) (expected_calculation__v) field.
3500A Devices
The 19R3 Data Model includes the following changes to support generating device information in FDA MedWatch 3500A report.
Product Object Changes
The Product (product__v) object now includes the Device (device__v) product type and the following fields:
| Field Label | Field Name |
|---|---|
| Generic Name | generic_name__v |
| Manufacturer | manufacturer__v |
Study Product Object Changes
The Study Product (study_product__v) object now includes the Device (device__v) product type.
Product Registration Object Changes
The Product Registration (product_registration__v) object now includes the Product Code (product_code__v) field.
Case Product Object Changes
The Case Product object (case_product__v) now includes the following fields:
| Field Label | Field Name |
|---|---|
| Catalog Number | catalog_number__v |
| Date Explanted | date_explanted__v |
| Date Implanted | date_implanted__v |
| Device Available | device_available__v |
| Operator of Device | device_operator__v |
| Operator of Device (Other) | device_operator_other__v |
| Lot Number | lot_number__v |
| Model Number | model_number__v |
| Product Type | product_type__v |
| Reprocessed/Reused | reprocessed__v |
| Reprocessor | reprocessor__v |
| Returned Date | returned_date__v |
| Serial Number | serial_number__v |
| Single Use | single_use__v |
| Unique Identifier | unique_identifier__v |
Organization Object Changes
The Organization (organization__v) object now includes the following fields:
| Field Label | Field Name |
|---|---|
| City | city__v |
| Country | country__v |
| Postal Code | postalcode__v |
| State/Province | state_province__v |
| Street | street__v |
Reporting Rules
Vault Safety 19R3 includes many data model changes to support reporting rules.
Note: Data model changes for reporting rules do not automatically appear in your vault. You must contact Veeva support to enable reporting rules.
The data model changes for reporting rules feature includes both regulatory agency submission rules (EMA, FDA, custom) and partner distribution rules.
New Safety Rule Object
The Safety Rule (safety_rule__v) object includes the following new fields:
| Field Label | Field Name |
|---|---|
| Overridden Rule | overridden_rule__v |
| Rule Priority | rule_priority__v |
| Rule Set | rule_set__v |
| Rule Status | rule_status__v |
New Safety Rule Set Object
Object Types
The Safety Rule Set (safety_rule_set__v) object includes the ICSR Reporting Rule Set (icsr_reporting_rule_set__v) object type.
Fields
The Safety Rule Set object includes the following new fields:
| Field Label | Field Name |
|---|---|
| Base Rule Set | base_rule_set__v |
| Eligibility Criteria | eligibility_criteria__v |
| Safety Rule Set Type | object_type__v |
New Safety Rule Function Object
The Safety Rule Function (safety_rule_function__v) object includes the following new fields:
| Field Label | Field Name |
|---|---|
| Rule Function Family | rule_function_family__v |
| Supported Rule Parameter | supported_rule_parameter__v |
New Safety Rule Function Family Object
The Safety Rule Function Family (safety_rule_function_family__v) object is new.
New Safety Rule Parameter Object
Object Types
The Safety Rule Parameter (safety_rule_parameter__v) object includes the following object types:
| Object Type Label | Object Type Name |
|---|---|
| Rule Set Parameter | rule_set_parameter__v |
| Rule Parameter | rule_parameter__v |
Fields
The Safety Rule Parameter object includes the following fields:
| Field Label | Field Name |
|---|---|
| Safety Rule Parameter Type | object_type__v |
| Parameter | parameter__v |
| Rule | rule__v |
| Rule Set | rule_set__v |
Organization Object Changes
The Organization (organization__v) object now includes the Submission Rule (submission_rules__v) field.
Product Registration Object Changes
The Product Registration (product_registration__v) object now includes the Reporting Organization (reporting_organization__v) field.
Study Registration Object Changes
The Study Registration (study_registration__v) object now includes the Reporting Organization (reporting_organization__v) field.
Reporting Family Object Changes
Object Types
The Reporting Family (reporting_family__v) object now includes the following object types:
| Object Type Label | Object Type Name |
|---|---|
| Partner Distribution | partner_distribution__v |
| Reporting Obligation | reporting_obligation__v |
Fields
The Reporting Family object now includes the Distribution Rules (distribution_rules__v) field.
Reporting Family Member Object Changes
Object Types
The Reporting Family Member (reporting_family_member__v) object now includes the following object types:
| Object Type Label | Object Type Name |
|---|---|
| Product Registration | product_registration__v |
| Study Registration | study_registration__v |
Fields
The Reporting Family Member object now includes the following fields:
| Field Label | Field Name |
|---|---|
| Product | product__v |
| Product Registration | product_registration__v |
| Reporting Organization | reporting_organization__v |
| Organization | source_organization__v |
| Study | study__v |
| Study Registration | study_registration__v |
Transmission Profile Object Changes
Object Types
The Transmission Profile (transmission_profile__v) object now includes the following object types:
| Object Type Label | Object Type Name |
|---|---|
| Manual | manual__v |
| System Gateway | system_gateway__v |
Fields
The Transmission Profile object now includes the Format (format__v) field.