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 Regulatory data model. These data model updates are automatically included in all Regulatory Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 24R2.
For the Enhanced Support for Parallel XEVMPD & IDMP feature, added the XEVMPD Combined Dosage Form field (xevmpd_combined_dosage_form__v) to the Medicinal Product object (medicinal_product__rim).
Updated the following to support the Define RLCP Output Document Type for Section Level Merge feature:
- Added the RLCP Section Output Document Type (
rlcp_section_output_document_type__v) field to the following:- Content Plan (
edl__v) object - Content Plan Template (
edl_template__v) object and its below object types:- Report (
report__v) - Report Level Plan Clinical Study (
report_level_plan_clinical_study__v) *Report Level Plan Nonclinical Study (report_level_plan_nonclinical_study__v)
- Report (
- Content Plan (
In all RIM Vaults, added the following object types to the Event (event__rim) object:
- Investigational Event (
investigational_event__v) - Safety Event (
safety_event__v)
In all RIM Vaults, enabled hierarchical copy on the following fields, listed by object:
- Product Manufacturer (
pharmaceutical_product_manufacturer__rim) object: Product (pharmaceutical_product__rim) field - Product Family Product (product_pharmaceutical_product__rim) object: Product (
pharmaceutical_product__rim) field - Packaging Container Component (
packaging_container_component__rim) object: Packaging (packaging__rim) field - Storage and Handling Condition (
storage_and_handling_condition__v) object: Product (product__v) field - Application Authorization (
application_authorization__v) object: Application (application__v) field - Application Regulatory Text (
application_regulatory_text__v) object: Application (application__v) field - Registered Inactive Ingredient (
registered_inactive_ingredient__rim) object: Registration (registration__rim) field
In all RIM Vaults, updated configuration to allow Admins to activate/inactivate (change the Status of) the following fields, listed by object:
- Fields in the Submission Metadata object (
submission_metadata__v):- Clinical Site Object id field (
clinical_site_object_id__v) - Clinical Site field (
clinical_site_record_id__v) - Clinical Study Object Id field (
clinical_study_object_id__v) - Clinical Study field (
clinical_study_record_id__v) - Product Object Id field (
drug_product_object_id__v) - Product field (
drug_product_record_id__v) - Active Substance Object Id field (
drug_substance_object_id__v) - Active Substance field (
drug_substance_record_id__v) - Inactive Ingredient Id field (
excipient_object_id__v) - Inactive Ingredient field (
excipient_record_id__v) - Indication field (
indication_record_id__v) - Manufacturer Object Id field (
manufacturer_object_id__v) - Manufacturer field (
manufacturer_record_id__v) - Nonclinical Study Id field (
nonclinical_study_object_id__v) - Nonclinical Study field (
nonclinical_study_record_id__v) - Product Variant Object Id field (
product_detail_object_id__v) - Product Variant field (
product_detail_record_id__v)
- Clinical Site Object id field (
- Shelf Life (
shelf_life__rim) field for the following objects:- Event Packaging object (
event_packaging__rim) - Registered Packaging object (
registration_packaging__rim), which includes a duplicate Shelf Life (shelf_life1__rim) field. - Submission Packaging object (
submission_packaging__rim)
- Event Packaging object (
- Registered Indication object (
registered_indication__rim): Full Indication Text field (full_indication_text__rim) - Registered Packaging object (
registration_packaging__rim):- Packaging Status Date field (
packaging_status_date__rim) - Packaging Status field (
packaging_status__rim). Note: This legacy field does not appear in all RIM Vaults.
- Packaging Status Date field (
- Registered Organization object (
registered_site_organization__v):- Make Contact Details Public field (
make_contact_details_public__v) - Use for UDI field (
use_for_udi__v)
- Make Contact Details Public field (
- Product object (
drug_product__v): Comparator Product field (comparator_product__v) - Registered Product object (
registered_drug_product__rim): Product Information URL field (product_information_url__v) - Manufacturer object (
manufacturer__v): Country field (country__rim)
In all RIM Vaults, enabled the User must always enter a value (required) configuration for the below fields, listed by object:
- Authorised Pharmaceutical Form (
authorised_pharmaceutical_form__v) object: Authorised Pharmaceutical Form (authorised_pharmaceutical_form__v) field - Activity (
activity__rim) object:- Impacted Product (
impacted_product__rim) - Impacted Product Variant (
impacted_presentation__rim)
- Impacted Product (
In all RIM Vaults, enabled the Values must be unique configuration for the External ID (external_id__v) field in the UDI Attribute Set (udi_attribute_set__v) object.
In all RIM Vaults, enabled Admins to configure the field length of the External ID (external_id__rim) field in the Content Plan Template (edl_template__v) object.
In all RIM Vaults, enabled the System manages field value (read-only) configuration for the name__v field in the following objects:
- Clinical Study (
clinical_study__v) - HA Meeting Clinical Study (
ha_meeting_clinical_study__v) - HA Meeting Commitment (
ha_meeting_commitment__v) - HA Meeting HAQ (
ha_meeting_haq__v) - HA Meeting Product Family (
ha_meeting_product_family__v) - HA Meeting Regulatory Objective (
ha_meeting_regulatory_objective__v) - HAQ-Labeling Deviation (
haqlabeling_deviation__v) - Health Authority Center (
health_authority_division__v) - Withdrawal Period Species (
withdrawal_period_species__v) - Site (
clinical_site__v)
In all RIM Vaults, enabled Admins to update the Picklist Status Value for the following values in the Name Part Type (name_part_type__rim) picklist:
- Invented Name (
invented_name__rim) - Pharmaceutical Dose Form (
pharmaceutical_dose_form_part__rim) - Scientific Name (
scientific_name__rim) - Strength (
strength__rim) - Trademark or Company Name (
trademark_or_company_name_part__rim)
In all RIM Vaults, enabled the System manages field value (read-only) configuration for the Vault RIM UUID (vault_rim_uuid__v) field in the Active Dossier Template (active_dossier_template__v) object.
In all RIM Vaults, added the following values to the Therapeutic Area (therapeutic_area__v) picklist:
- Cardiology/Vascular Diseases (
cardiologyvascular_diseases__v) - Dental/Maxillofacial Surgery (
dentalmaxillofacial_surgery__v) - Dermatology/Plastic Surgery (
dermatologyplastic_surgery__v) - Endocrinology (
endocrinology__v) - Gastroenterology (
gastroenterology__v) - Hematology (
hematology__v) - Immunology/Infectious Diseases (
immunologyinfectious_diseases__v) - Musculoskeletal (
musculoskeletal__v) - Nephrology/Urology (
nephrologyurology__v) - Neurology (
neurology__v) - Obstetrics/Gynecology (
obstetricsgynecology__v) - Oncology (
oncology__v) - Ophthalmology (
ophthalmology__v) - Otolaryngology (
otolaryngology__v) - Pediatrics/Neonatology (
pediatricsneonatology__v) - Pharmacology/Toxicology (
pharmacologytoxicology__v) - Psychiatry/Psychology (
psychiatrypsychology__v) - Pulmonary/Respiratory Diseases (
pulmonaryrespiratory_diseases__v) - Rheumatology (
rheumatology__v) - Trauma/Emergency Medicine (
traumaemergency_medicine__v)
In 24R2, we are also implementing additional data model changes to support faster and more accurate Vault RIM implementations.
Added or updated the following components to support the Registrations Data Model Updates feature:
- Enabled Admins to update the Picklist Status Value for standard values in the Reason for Inactivation (
reason_for_inactivation__v) picklist. - Added National Code (
national_code__v):- As a Identifier Type (
identifier_type__v) picklist value. - As a Registered Packaged Product (
registered_packaged_medicinal_product__v) object field.
- As a Identifier Type (
- Enabled the Audit data changes in this object configuration on the following objects:
- HAQ-Labeling Deviation (
haqlabeling_deviation__v) - Withdrawal Period (
withdrawal_period__v) - Withdrawal Period Species (
withdrawal_period_species__v)
- HAQ-Labeling Deviation (
- Added the Medicinal Product Container (
container__v) object type to the Shelf Life or Condition (shelf_life__rim) object. - Added or updated Rimobjectconfigurations for the following manufacturing details fields:
- Authorisation Effective Date (
authorisation_effective_date__v) - Confidentiality Indicator (
confidentiality_indicator__v) - Health Authority (
health_authority__v) - Manufacturing Authorisation Number (
manufacturing_authorisation_number__v) - Manufacturing Operation Start Date (
manufacturing_operation_start_date__v) - Manufacturing Operation Stop Date (
manufacturing_operation_stop_date__v)
- Authorisation Effective Date (
Added or updated the following to support the Support auto-matching of RLCP Documents into SCP feature:
* Added the Report Level Content Plan (report_level_content_plan__v) field to the following objects:
* Submission Clinical Study (submission_clinical_study__rim)
* Submission Nonclinical Study (submission_nonclinical_study__rim)
* Added the Report Level Content Plan (report_level_content_plan__v) field to the following object types:
* Module 4 (module_4__rim)
* Module 5 (module_5___rim)
Added the following to support the Dispatch Global Content Plan Across Templates feature:
- Added the Content Plan Item Template Mapping (
content_plan_item_template__mapping__v) object and the following fields:- Source Content Plan Item Template (
source_content_plan_item_template__v) - Target Content Plan Item Template (
target_content_plan_item_template__v) - Source Content Plan Template Root (
source_content_plan_template_root__v) - Target Content Plan Template Root (
target_content_plan_template_root__v) - Source Content Plan Template Section (
source_content_plan_template_section__v) - Target Content Plan Template Section (
target_content_plan_template_section__v)
- Source Content Plan Item Template (
- Added the following fields to the indicated objects:
- Content Plan Template (
edl_template__v) object:- Root Content Plan Template (
root_content_plan_template__v)
- Root Content Plan Template (
- Content Plan Item Template (
edl_item_template__v) object:- Root Content Plan Template (
root_content_plan_template__v)
- Root Content Plan Template (
- Dispatch Message (
dispatch_message__v) object:- Document Only Dispatch (
document_only_dispatch__v) - Target Content Plan Template (
target_content_plan_template__v) - Number of Unmapped Documents (
number_of_unmapped_documents__v)
- Document Only Dispatch (
Added the following to support the Health Authority Question Extraction feature:
- Added the following objects:
- HA Question Submission (
health_authority_question_submission__v) - HA Question Commitment (
health_authority_question_commitment__v) - HA Question Application (
health_authority_question_application__v) - HA Question Product Family (
health_authority_question_product_family__v) - HA Question Reg Obj (
health_authority_question_regulatory_objective__v) - Commitment Clinical Study (
commitment_clinical_study__v) - Commitment Nonclinical Study (
commitment_nonclinical_study__v) - Commitment Regulatory Objective (
commitment_regulatory_objective__v)
- HA Question Submission (
- Added the following object fields to the indicated objects:
- Health Authority Question (
health_authority_question__rim) object- Question Source (
question_source__v) - Question Source Document (
question_source_document__v) - Question Annotation ID (
question_annotation_id__v) - Question Source Document ID (
question_source_document_id__v) - Primary Product Family (
product__v) - Related Application (
applications__v) - Question Topic (
question_topic__v) - CTD Sections Impacted (
ctd_sections_impacted__v) - Country (
country__v)
- Question Source (
- Commitment (
commitment__rim) object- Primary Product Family (
product__v) - Related Application (
applications__v) - Country (
country__v)
- Primary Product Family (
- Health Authority Question (
- Added the following document fields and related picklists for picklist fields:
- Health Authority Questions (
health_authority_question__v) - Commitments (
commitment__v) - Correspondence Scope (
correspondence_scope__v) - Date Received (
date_received__v) - Regulatory Objectives (
regulatory_objectives__v) - Method of Communication (
method_of_communication__v)
- Health Authority Questions (
- Added the Correspondence Details (
correspondence_details__v) document field layout - Added the Health Authority Question (
health_authority_question__v) layout