Pre-Release Date: March 25, 2024 | Release Date: April 18, 2024 & April 26, 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 data model. These data model updates are automatically included in all Safety Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 24R1.
For information about data model changes related to Vault Platform, see 24R1 Data Model Changes: Platform.
Safety
The following changes were made to support the Safety Data Validation Exception Handling feature:
- Added the Error State (
error_state__v
) Object State Type.
The following changes were made to support the Case Assignment feature:
- Added the Case Assignment Team Lifecycle (
case_assignment_team_lifecycle__v
) object lifecycle - Added the User Team Assignment Lifecycle (
user_team_assignment_lifecycle__v
) object lifecycle - Added the User Assignment Attributes Lifecycle (
user_assignment_attributes_lifecycle__v
) object lifecycle
The following changes were made to support the Product Problem Available in Device Report Type Picklist for FDA 3500A Generation feature:
- Added the Product Problem (
product_problem__v
) value to the Device Report Type (device_report_type__v
) picklist.
The following changes were made to support the Create and Export Case and Safety Report Collections feature:
- Added the Case Collection (
case_collection__v
) object with the following object types:- CIOMS I PII Masked & Study Blinded (
cioms1_pii_masked_study_blinded__v
) - CIOMS I PII Unmasked & Study Unblinded (
cioms1_pii_unmasked_study_unblinded__v
) - E2B R3 (
e2b__v
)
- CIOMS I PII Masked & Study Blinded (
- Added the following fields to the Case Collection (
case_collection__v
) object:- Name (
name__v
) - Collection Title (
title__v
) - Description (
description__v
) - Last Ran (
last_ran__v
) - CIOMS I Masked Document Collection (
cioms1_masked_document_collection__v
) - CIOMS I Unmasked Document Collection (
cioms1_unmasked_document_collection__v
) - E2B R3 Document Collection (
e2b_document_collection__v
)
- Name (
- Added the Case Collection Lifecycle (
case_collection_lifecycle__v
) object lifecycle with the following states:- Active (
active_state__v
) - Inactive (
inactive_state__v
)
- Active (
- Added the Case Collection-Case Number (
case_collection_case_number__v
) object with the following fields:- Name (
name__v
) - Case Collection (
case_collection__v
) - Case Number (
case_number__v
)
- Name (
- Added the Case Collection Case Number Lifecycle (
case_collection_case_number_lifecycle__v
) object lifecycle with the following states:- Active (
active_state__v
) - Inactive (
inactive_state__v
)
- Active (
- Added the following fields to the Case Number (
case_number__v
) object:- CIOMS I - Masked (
cioms1_masked__v
) - CIOMS I - Unmasked (
cioms1_unmasked__v
) - E2B (R3) (
e2b__v
)
- CIOMS I - Masked (
- Added the Case Binder (
case_binder__v
) document type to the General Document Lifecycle (general_document_lifecycle__v
) document lifecycle with the following document subtype:- Case Collection Binder (
case_collection_binder__v
) with the following document classifications:- CIOMS Masked Case Collection (
cioms1_masked_case_collection__v
) - CIOMS Unmasked Case Collection (
cioms1_unmasked_case_collection__v
) - E2B Case Collection (
e2b_case_collection__v
)
- CIOMS Masked Case Collection (
- Case Collection Binder (
The following changes were made to support the Japan: One Last Time Reporting feature:
- Added the Local Expedited Criteria (
local_expedited__v
) field to the following objects:- Localized Case Assessment (
localized_case_assessment__v
) - Case Product Registration (
case_product_registration__v
) - Local Reporting Details (
local_reporting_details__v
)
- Localized Case Assessment (
The following changes were made to support the Manage Custom Dose Forms, Routes of Administration, and Units of Measurement feature:
- Added the following object types to the Dictionary (
dictionary__v
) object:- Agency Unit of Measurement (
agency_unit_of_measurement__v
) - Dose Form (
dose_form__v
) - Route of Administration (
route_of_administration__v
) - Unit of Measurement (
unit_of_measurement__v
) with the following fields:- Created By (
created_by__v
) - Created Date (
created_date__v
) - Dictionary Type (
object_type__v
) - Global ID (
global_id__sys
) - ID (
id__v
) - 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
)
- Created By (
- Agency Unit of Measurement (
- Added the following fields to the Agency Unit of Measurement (
agency_unit_of_measurement__v
) object:- Created By (dictionary) (
created_by_dictionary__v
) - Deprecated (
deprecated__v
) - Last Modified By (dictionary) (
modified_by_dictionary__v
) - System Managed (
system_managed__v
)
- Created By (dictionary) (
- Added the following fields to the Dose Form (
dose_form__v
) object:- Created By (dictionary) (
created_by_dictionary__v
) - Deprecated (
deprecated__v
) - Last Modified By (dictionary) (
modified_by_dictionary__v
) - System Managed (
system_managed__v
)
- Created By (dictionary) (
- Added the following fields to the Route of Administration (
route_of_administration__v
) object:- Created By (dictionary) (
created_by_dictionary__v
) - Deprecated (
deprecated__v
) - Last Modified By (dictionary) (
modified_by_dictionary__v
) - System Managed (
system_managed__v
)
- Created By (dictionary) (
- Added the following fields to the Unit of Measurement (
unit_of_measurement__v
) object:- Created By (dictionary) (
created_by_dictionary__v
) - Deprecated (
deprecated__v
) - Last Modified By (dictionary) (
modified_by_dictionary__v
) - System Managed (
system_managed__v
)
- Created By (dictionary) (
The following changes were made to support the Update to Seriousness Picklist feature:
- Added the Required Intervention to Prevent Permanent Impairment/Damage (Devices) (
required_intervention_devices__v
) picklist value to the Seriousness (seriousness__v
) field on the Case Adverse Event (case_adverse_event__v
) object. - Added the Required Intervention to Prevent Permanent Impairment/Damage (Devices) (
required_intervention_devices__v
) picklist value to the Primary Event Seriousness (seriousness__v
) field on the Case (case_version__v
) object.
The following changes were made to support the Datasheet Expectedness by Age and Sex feature:
- Added the following fields to the MedDRA Criteria (
meddra_criteria__v
) and Datasheet MedDRA Query (datasheet_meddra_query__v
) objects:- Age Range Start (
age_range_start__v
) - Age Range Start (normalized) (
age_range_start_normalized__v
) - Age Range Start (Unit) (
age_range_start_unit__v
) - Age Range End (
age_range_end__v
) - Age Range End (normalized) (
age_range_end_normalized__v
) - Age Range End (Unit) (
age_range_end_unit__v
) - Sex (
gender__v
)
- Age Range Start (
- Added the Unit of Measurement (
unit_of_measurement_picklist__v
) picklist to the Age Range Start (Unit) (age_range_start_unit__v
) and Age Range End (Unit) (age_range_end_unit__v
) fields. - Added the Age Range Start (
age_range_start__v
) field to the Controlled Vocabulary (controlled_vocabulary__v
) object with the following default start values:
Age Group | Value |
---|---|
Foetus (foetus__v ) |
blank |
Neonate (neonate__v ) |
0 |
Infant (infant__v ) |
0.0767 |
Child (child__v ) |
2 |
Adolescent (adolescent__v ) |
12 |
Adult (adult__v ) |
18 |
Elderly (elderly__v ) |
65 |
The following changes were made to support the Clinical Trials: Isolate Blinded Product Information feature:
- Added the Blinding Type (
blinding_type__v
) field with the following picklist values:- Blinded (
blinded__v
) - Unblinded (
unblinded__v
) - Open (
open__v
)
- Blinded (
- Added the Blinded Reference (
blinded_reference__v
) field - Added the Blinding Type (
blinding_type__v
) field and Blinded Reference (blinded_reference__v
) object reference field to the following Case child objects:- Case Product (
case_product__v
) for the Study Product (study_product__v
) object type - Case Assessment (
case_assessment__v
)
- Case Product (
- Added the Blinding Type (
blinding_type__v
) and Blinded Reference ID (blinded_reference_id__v
) fields to the following Case grandchild objects:- Case Product Substance (
case_product_substance__v
) - Case Product Dosage (
case_product_dosage__v
) - Case Product Indication (
case_product_indication__v
) - Case Product Registration (
case_product_registration__v
) - Case Product Device Code (
case_product_device_code__v
) for all object types - Case Assessment Expectedness (
case_assessment_expectedness__v
) - Case Assessment Result (
case_assessment_result__v
)
- Case Product Substance (
- Added the Blinding Type (
blinding_type__v
) field and Blinded Reference (blinded_reference__v
) object reference field to the following Localized Case child objects:- Localized Case Product (
localized_case_product__v
) - Localized Case Assessment (
localized_case_assessment__v
)
- Localized Case Product (
- Added the Blinding Type (
blinding_type__v
) field and Blinded Reference ID (blinded_reference_id__v
) object reference field to the following Localized Case grandchild objects:- Localized Case Product Substance (
localized_case_product_substance__v
) - Localized Case Product Dosage (
localized_case_product_dosage__v
) - Localized Case Product Indication (
localized_case_product_indication__v
) - Localized Case Product Registration (
localized_case_product_registration__v
) - Localized Case Product Device Code (
localized_case_product_device_code__v
) - Localized Case Assessment Expectedness (
localized_case_assessment_expectedness__v
) - Localized Case Assessment Result (
localized_case_assessment_result__v
)
- Localized Case Product Substance (
- Added the Case Blinded (
case_blinded__v
) and Blind Protection (blind_protection__v
) lookup fields to the objects:- Case Product (
case_product__v
) - Case Assessment (
case_assessment__v
) - Case Product Substance (
case_product_substance__v
) - Case Product Dosage (
case_product_dosage__v
) - Case Product Indication (
case_product_indication__v
) - Case Product Registration (
case_product_registration__v
) - Case Product Device Code (
case_product_device_code__v
) - Case Assessment Expectedness (
case_assessment_expectedness__v
) - Case Assessment Result (
case_assessment_result__v
) - Localized Case Product (
localized_case_product__v
) - Localized Case Assessment (
localized_case_assessment__v
) - Localized Case Product Substance (
localized_case_product_substance__v
) - Localized Case Product Dosage (
localized_case_product_dosage__v
) - Localized Case Product Indication (
localized_case_product_indication__v
) - Localized Case Product Registration (
localized_case_product_registration__v
) - Localized Case Product Device Code (
localized_case_product_device_code__v
) - Localized Case Assessment Expectedness (
localized_case_assessment_expectedness__v
) - Localized Case Assessment Result (
localized_case_assessment_result__v
)
- Case Product (
The following changes were made to support the Sender-Based Inbound Validations feature:
- Added the Rejection Reason (
rejection_reason__v
) field to the Inbox Item (inbox_item__v
) object - Added the Rejected (
rejected_state__v
) state to the following lifecycles:- Object Lifecycle: Transmission Lifecycle (
transmission_lifecycle__v
) - Document Lifecycle: AER Lifecycle (
aer_lifecycle__v
)
- Object Lifecycle: Transmission Lifecycle (
- Added the Inbound Validation Rule (
inbound_validation_rule__v
) object - Added the following fields to the Inbound Validation Rule (
inbound_validation_rule__v
) object:- Transmission Profile (
transmission_profile__v
) - Validation Criteria (
validation_criteria__v
)
- Transmission Profile (
- Added the Inbound Validation Result (
inbound_validation_result__v
) object - Added the following fields to the Inbound Validation Rule (
inbound_validation_rule__v
) object:- Access Group (
access_group__v
) - Agency (
agency__v
) - Conformance (
conformance__v
) - Data Element (
data_element__v
) - Data Element Name (
data_element_name__v
) - File Format (
file_format__v
) - Inbox Item (
inbox_item__v
) - Lifecycle (
lifecycle__v
) - Lifecycle State (
state__v
) - Organization (
organization__v
) - Validation Criteria (
validation_criteria__v
) - Validation Criteria Version (
validation_criteria_version__v
) - Validation Status (
validation_status__v
) with the following picklist values:- Pass (
pass__v
) - Fail (
fail__v
) - Warning (
warning__v
) - Hard Fail (
hard_fail__v
) - Error (
error__v
) - In Progress (
in_progress__v
)
- Pass (
- Vault Field (
target_field_label__v
) - Vault Object (
target_object_label__v
)
- Access Group (
The following changes were made to support the Safety Inbox Loader: Multi-CSV ZIP Data Import for VAERS, KAERS, and Custom Formats feature:
- Added the Tabular Source File (
tabular_source_file__v
) object. - Added the following fields to the Tabular Source File (
tabular_source_file__v
) object:- Name (
name__v
) - Standard Format (
standard_format__v
) with the following picklist value:- VAERS Symptoms (
vaers_symptoms__v
)
- VAERS Symptoms (
- Tabular Data Format (
tabular_data_format__v
) - Target Object Name (
target_object__v
)
- Name (
- Added the following new fields to the Tabular Data Format (
tabular_data_format__v
) object:- Country (
country__v
) - Encoding (
encoding__v
) with the following picklist values:- UTF (
utf8__v
) - EUC-KR (
euc_kr__v
) - ISO-8859-1 (
ISO-8859-1__v
)
- UTF (
- Country (
The following changes were made to support the Two-Way Relationships between Multi-Case and Single-Case Files feature:
- Added the following document relationship types to the Adverse Event Report (
adverse_event_report__v
) classification:- Multi-Case Document (
multicase__v
) - Single-Case Document (
singlecase__v
)
- Multi-Case Document (
The following changes were made to support the QC Checklist Generation feature:
- Added the following objects:
- Checklist Creation Rule (
checklist_creation_rule__v
) - Checklist Creation Rule Criteria (
checklist_creation_rule_criteria__v
) - Case Checklist Rule Assignment (
case_checklist_rule_assignments__v
) - Case Processing User (
case_processing_user__v
) - Case Checklist (
case_checklist__v
)
- Checklist Creation Rule (
- Added the following fields to the Checklist Creation Rule (
checklist_creation_rule__v
) object:- Bypass Checklist (
bypass_checklist__v
) - Checklist Design (
checklist_design__v
) - Processing Order (
processing_order__v
) - Rule Phase (
rule_phase__v
) with the following picklist values:- Quality Control (
quality_control__v
) - Medical Review (
medical_review__v
) - Final Review (
final_review__v
) - Closed (
closed__v
)
- Quality Control (
- Rule Type (
rule_type__v
) with the following picklist values:- In-Process (
in_process__v
) - Post-Closure (
post_closure__v
)
- In-Process (
- Sampling Percentage (
sampling_percentage__v
)
- Bypass Checklist (
- Added the following fields to the Checklist Creation Rule Criteria (
checklist_creation_rule_criteria__v
) object:- Checklist Creation Rule (
checklist_creation_rule__v
) - Rule Criteria For All (
rule_criteria_for_all__v
) - Rule Expression (
rule_expression__v
)
- Checklist Creation Rule (
- Added the following fields to the Case Checklist Rule Assignment (
case_checklist_rule_assignments__v
) object:- Assigned To (
assigned_to__v
) - Case (
case__v
) - Case Access Group (
case_access_group__v
) - Case Assignment Team (
case_assignment_team__v
) - Case Checklist (
case_checklist__v
) - Checklist Creation Rule (
checklist_creation_rule__v
) - Checklist Lifecycle State (
checklist_lifecycle_state__v
) - Rule Type (
rule_type__v
) with the following picklist values:- In-Process (
in_process__v
) - Post-Closure (
post_closure__v
)
- In-Process (
- Assigned To (
- Added the following fields to the Case Processing User (
case_processing_user__v
) object:- Case (
case__v
) - Phase (
phase__v
) with the following picklist values:- Intake (
intake__v
) - Data Entry (
data_entry__v
) - Quality Control (
quality_control__v
) - Medical Review (
medical_review__v
) - Final Review (
final_review__v
) - Closure (
closure__v
)
- Intake (
- User (
user__v
)
- Case (
- Added the following fields to the Case Checklist (
case_checklist__v
) object:- Ad Hoc Questions Allowed (
ad_hoc_questions_allowed__sys
) - Ad Hoc Sections Allowed (
ad_hoc_sections_allowed__sys
) - Aggregate Checklists (
aggregate_checklists__sys
) - Checklist Category (
checklist_type__sys
) - Checklist Design (
checklist_design__sys
) - Field Matching Enabled (
field_matching_enabled__sys
) - Lifecycle (
lifecycle__v
) - Lifecycle Stage (
stage__sys
) - Lifecycle State (
state__v
) - Lifecycle State Stage ID (
state_stage_id__sys
) - Object Type (
object_type__v
) - Person Responsible (
person_responsible__sys
) - Points (
points__sys
) - Respondent (
respondent__sys
) - Score % (
score__sys
) - Sum Score (
sum_score__sys
) - Target Object (
target_object__v
) - User Responsible (
user_responsible__sys
) - Weightings Enabled (
weightings_enabled__sys
) - Welcome Email Subject (
welcome_email_subject__sys
) - Welcome Email Text (
welcome_email_text__sys
) - Welcome Notification Text (
welcome_notification_text__sys
)
- Ad Hoc Questions Allowed (
- Added the Checklist Bypass (
checklist_bypass__v
) field to the Case (case__v
) object
The following changes were made to support the Safety-EDC Connection: Serious Adverse Event Reports feature:
- Added the following objects:
- CDMS Subject Adverse Event (
cdms_subject_adverse_event__v
) - CDMS Subject Case Product (
cdms_subject_product__v
) - CDMS Subject Case Product Dosage (
cdms_subject_product_dosage__v
) - CDMS Subject Cause of Death (
case_cause_of_death__v
) - CDMS Subject Drug History (
cdms_subject_drug_history__v
) - CDMS Subject Event Product Assessment (
cdms_subject_event_product_assessment__v
) - CDMS Subject Height History (
cdms_subject_height_history__v
) - CDMS Subject Information (
cdms_subject_information__v
) - CDMS Subject Last Menstruations (
cdms_subject_last_menstruations__v
) - CDMS Subject Links (
cdms_subject_links__v
) - CDMS Subject Medical History (
cdms_subject_medical_history__v
) - CDMS Subject Pregnancy Information (
cdms_subject_pregnancy_information__v
) - CDMS Subject Test Results (
cdms_subject_test_results__v
) - CDMS Subject Weight History (
cdms_subject_weight_history__v
) - Added the CDMS Subject Information (
cdms_subject_information__v
) field to the Inbox Item (inbox_item__v
) object. - Added the Subject Information Review (
subject_information_review__v
) field to the User Access Group Assignment (user_access_group_assignment__v
) object.
- CDMS Subject Adverse Event (
- Added the following picklists:
- Link member type (
link_member_type__v
) - Reason (
reason__v
) - Subject Information Review (
subject_information_review__v
) - Transaction Type (
cdms_transaction_type__v
)
- Link member type (
- Added the Data (
data__v
) value to the Intake Format (intake_format__v
) picklist.- Added the CDMS Connection (
vault_cdms_connection__v
) value to the Intake Method (intake_method__v
) picklist.
- Added the CDMS Connection (
- Added the Safety-EDC Connection (
safety_cdms_connection__v
) connection. - Added the Safety-EDC: Serious Adverse Events (
sae_integration__v
) integration. - Added the following integration points:
- Safety-EDC: CDMS Safety Case Inbound (
cdms_case_inbound_int_point__v
) - Safety-EDC: Case Information (
cdms_case_outbound_int_point__v
)
- Safety-EDC: CDMS Safety Case Inbound (
The following changes were made to support the Safety-Clinical Operations Vault Connection: Safety Letters feature:
- Added the following objects:
- Clinical Outbound Event (
clinical_outbound_event__v
) - Transmission Study (
transmission_study__v
)
- Clinical Outbound Event (
- Added the following components to the Transmission Message (
transmission_message__v
) object:- Connection Event Type (
connection_event_type__v
) object type - Connection Event (
connection_event__v
) field - Connection Event Type (
connection_event_type__v
) field
- Connection Event Type (
- Added the Vault Clinical (
vault_clinical__v
) value to the Transmission Profile picklist. - Added the following values to the Connection Event Type (
connection_event_type__v
) picklist:- Distribution Sent (
distribution_sent__v
) - Pending Distribution (
pending_distribution__v
)
- Distribution Sent (
- Added the Pending Distribution (
pending_distribution_state__v
) state to the Transmission Lifecycle (pending_distribution_state__v
). - Added the Safety Distributions Integration (
safety_distribution_integration__v
) integration. - Added the following integration points:
- Safety Distribution Created Inbound Integration Point (
clinical_safety_dist_created_int_pt__v
) - Safety Distribution Distributed Inbound Integration Point (
clinical_safety_dist_distribtd_int_pt__v
) - Safety Distribution Outbound Integration Point (
clinical_safety_dist_created_int_pt__v
)
- Safety Distribution Created Inbound Integration Point (
- Added the Pending Distribution (
pending_distribution_state__v
) state to the Transmission Lifecycle (transmission_lifecycle__v
). - Added the following standard records:
- Organization (
organization__v
) object: Vault Clinical (vault_clinical__v
) - Transmission Profile (
transmission_profile__v
) object: Vault Clinical (vault_customer__v
)
- Organization (
The following changes were made to support the Medical-Safety Connection: Adverse Event Reports feature:
- Added the Medical Safety Connection (
medical_safety__v
) connection. - Added the Adverse Event Integration (
adverse_event_i__v
) integration. - Added the following integration points:
- Adverse Event Integration Point (
adverse_event_oip__v
) - Adverse Event Integration Point (
adverse_event_iip__v
)
- Adverse Event Integration Point (
The following changes were made to support the Japan Periodic Reporting: Post-Market Non-Serious (NUPR) feature:
- Added the PMDA Post-Market (
pmda_postmarket__v
) object type to the Aggregate Report (aggregate_report__v
) object. - Added the following fields to the PMDA Post-Market (
pmda_postmarket__v
) object type:- Aggregate Report Template (
aggregate_report_template__v
) - Aggregate Report Type (
object_type__v
) - Aggregate Reporting Group (
aggregate_reporting_group__v
) - Created By (
created_by__v
) - Created Date (
created_date__v
) - Data Period End (
data_period_end__v
) - Data Period Start (
data_period_start__v
) - Documents to Generate (
documents_to_generate__v
) with the following overidden picklist value:- NUPR Line Listing Form 7-2 (
nupr_line_listing_form_72__v
)
- NUPR Line Listing Form 7-2 (
- Earliest Submission Date (
earliest_submission_date__v
) - External ID (
external_id__v
) - Filter Case By (
filter_case_by__v
) - Global ID (
global_id__sys
) - ID (
id
) - Include Criteria Page on Documents (
include_criteria_page__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
) - Organization (
organization__v
) - Product Family (
product_family__v
) - Report Description (
report_description__v
) - States to Include (
states_to_include__v
) - Status (
status__v
)
- Aggregate Report Template (
- Added the PMDA Post-Market (
pmda_postmarket__v
) document type (Classification) to the Postmarketing (postmarketing__v
) document type (Subtype). - Added the J-NUPR Non-Serious Unlisted Periodic Report (
jnupr_nonserious_unlisted_periodic_rep__v
) document type (Classification) to the Summary Tabulation (summary_tabulation__v
) document type (Subtype). - Added the PMDA Post-Market (
pmda_postmarket__v
) document template type to the Aggregate Report (aggregate_report__v
) document template type . - Added the J-NUPR Non-Serious Unlisted Periodic Report (
jnupr_nonserious_unlisted_periodic_rep__v
) document template type (Classification) to the Aggregate Summary Tabulation (aggregate_summary_tabulation__v
) document template type (Subtype).
Additional Data Model Updates
The following additional changes were made:
- Increased the maximum length of the Product (Coded) (
product_name__v
) field on the Case Product (case_product__v
) object from 250 to 1,500 characters. - Added the Case Assignment Team Lifecycle (
case_assignment_team_lifecycle__v
) object lifecycle. - Added the User Team Assignment Lifecycle (
user_team_assignment_lifecycle__v
) object lifecycle. - Added the User Assignment Attributes Lifecycle (
user_assignment_attributes_lifecycle__v
) object lifecycle.
Safety & SafetyDocs
The following changes were made to support the Redacted Document Tracking feature:
- Added the following document relationship types to the Base Document (
base_document__v
) document type:- Redacted Document (
redacted__v
) - Unredacted Document (
unredacted__v
)
- Redacted Document (
- Added the Redaction (
redaction__v
) field to the Base Document (base_document__v
) document type with the following picklist value:- PII Redacted (
pii_redacted__v
)
- PII Redacted (
The following changes were made to support the Create Inbox Item from Literature Article feature:
- Added the following fields to the Inbox Item (
inbox_item__v
) object:- Source Literature Article (
source_literature_article__v
) - Source Literature Review (
source_literature_review__v
) - Number of Cases (
number_of_cases__v
)
- Source Literature Article (
- Added the Literature Promotion (
literature_promotion__v
) value to the Intake Method (intake_method__v
) picklist on the Inbox Item (inbox_item__v
) object. - Added the Literature Article (
literature_article__v
) value to the Intake Format (intake_format__v
) picklist on the Inbox Item (inbox_item__v
) object. - Added the following fields to the Case (
case_version__v
) object:- Source Literature Article (
source_literature_article__v
) - Source Literature Review (
source_literature_review__v
)
- Source Literature Article (
- Added the following fields to the Literature Article (
literature_article__v
) object:- Country of Publication (
country_of_publication__v
) - Place of Publication (
place_of_publication__v
) - Product (
product__v
)
- Country of Publication (
The following changes were made to support the Aggregate Reporting: Combine Tabulations and Authoring feature:
- Added the following values to the Documents to Generate (
document_to_generate__v
) picklist:- CIOMS II Interval Line Listings (
cioms_ii_interval_line_listings__v
) - PSUR Summary Tabulation of ADRs (
psur_summary_tabulation_of_adrs__v
) - PSUR Interval Line Listings (
psur_interval_line_listings__v
)
- CIOMS II Interval Line Listings (
- Added the following fields to the Aggregate Report Section (
aggregate_report_task__v
) object:- Report Document (Masked) (
report_document_masked__v
) - Report Document (Log) (
report_document_log__v
) - Document to Generate (
document_to_generate__v
) - Tabulation Generation Date (
tabulation_generation_date__v
)
- Report Document (Masked) (
- Added the Safety Tabulation (
safety_tabulation__v
) object type to the Aggregate Report Section (aggregate_report_task__v
) object and the Aggregate Report Template Item (aggregate_report_template_item__v
) object with the following fields:- Aggregate Report (
aggregate_report__v
) - Aggregate Report Destination (
aggregate_report_destination__v
) - Aggregate Report Task Type (
object_type__v
) - Aggregate Report Template (
aggregate_report_template__v
) - Aggregate Report Template Item (
aggregate_report_template_item__v
) - Document to Generate (
document_to_generate__v
) - Aggregate Report Type (
aggregate_report_type__v
) - Assigned To (
assigned_to__v
) - Complete (
complete__v
) - Completion Date (
completion_date__v
) - Task Order (
task_order__v
) - Report Document (
report_document__v
) - Report Document (Masked) (
report_document_masked__v
) - Report Document (Log) (
report_document_log__v
) - Tabulation Generation Date (
tabulation_generation_date__v
)
- Aggregate Report (
- Added the Document to Generate (
document_to_generate__v
) field to the Aggregate Report Template Item (aggregate_report_template_item__v
) object.
SafetyDocs
The following changes were made to support the PVA: Document Distribution via Email feature:
- Added the following fields to the PVA Activity (
pva_activity__v
) object:- Activity Type (
activity_type__v
) with the following picklist values:- Inbound (
inbound__v
) - Outbound (
outbound__v
)
- Inbound (
- Message Subject (
message_subject__v
) - Message Body (
message_body__v
)
- Activity Type (
- Added the Distribution Error (
distribution_error_state__v
) state to the PVA Activity (pva_activity_lifecycle__v
) lifecycle. - Added the following fields to the PVA Action Item (
pva_action_item__v
) object:- Activity Type (
activity_type__v
) with the following picklist values:- Inbound (
inbound__v
) - Outbound (
outbound__v
)
- Inbound (
- Message Subject (
message_subject__v
) - Message Body (
message_body__v
)
- Activity Type (
- Added the following states to the PVA Action Item (
pva_action_item_lifecycle__v
) lifecycle:- Sent to Partner (
sent_to_partner_state__v
) - Distribution Error (
distribution_error_state__v
)
- Sent to Partner (
- Added the PVA Document for Distribution (
pva_document_distribution__v
) object with the following fields:- Document for Distribution (
document__v
) - PV Agreement (
pv_agreement__v
) - PVA Activity (
pva_activity__v
) - PVA Action Item (
pva_action_item__v
) - Sent Date (
sent_date__v
) - Link Expiry Date (
link_expiry_date__v
) - Token (
token__v
)
- Document for Distribution (
- Added the PVA Document Distribution Lifecycle (
pva_document_distribution_lifecycle__v
) with the following states:- Active (
active_state__v
) - Inactive (
inactive_state__v
)
- Active (
- Added the PVA Document Distribution Event (
pva_document_distribution_event__v
) object with the following fields:- Event Details (
event_details__v
) - Event Time (
event_time__v
) - Event Type (
event_type__v
) - Recipient (
recipient__v
) - Email Message ID (
email_message_id__v
) - PV Agreement (
pv_agreement__v
) - PVA Action Item (
pva_action_item__v
) - PVA Activity (
pva_activity__v
)
- Event Details (
The following changes were made to support the Document Distribution to Partners via Vault Task feature:
- Added the Document Recipient (
document_recipient__v
) application role to the following lifecycles:- PVA Activity Lifecycle (
pva_activity_lifecycle__v
) - PVA Action Item Lifecycle (
pva_action_item_lifecycle__v
) - PVA Document Distribution Lifecycle (
pva_document_distribution_lifecycle__v
)
- PVA Activity Lifecycle (
- Added the Partner Access (
partner_access__v
) field on the PVA Activity (pva_activity__v
) object with the following picklist value:- Access Granted (
access_granted__v
)
- Access Granted (
- Added the Partner Access (
partner_access__v
) field on the PVA Action Item (pva_action_item__v
) object with the following picklist value:- Access Granted (
access_granted__v
)
- Access Granted (