Calyx RIM 6.2 Release Notes

Query Fields Updated: Calyx RIM 6.2

The following table describes fields that were updated or removed with Calyx RIM 6.2.

Table 1. Administration Queries
Query Name Field Name Field Type Description Business Rules
Entity Audit Trail Manufacturer Name N/A The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code in the Search Results > Manufacturer Name column for the Manufacturer-related subqueries. No updates to the business rules.
Table 2. Product Detail Management Queries
Query Name Field Name Field Type Description Business Rules
Application History Query Event Closed As Multi-select list The field has been renamed as Associations Closed As. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Associations Closed As column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Event Closed Date Date The field has been renamed as Closed Date. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Closed Date column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Manufacturer Name N/A The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code in the Search Results > Manufacturer Name column for the Manufacturer-related subqueries. No updates to the business rules.
N/A N/A The following column names have been changed in the Substance Details Changed? subquery:
  • Excipient Role is renamed to Substance Role
  • Excipient Name to Substance Name
N/A
Application QC Status History Report Event Closed As Multi-select list The field has been renamed as Associations Closed As. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Associations Closed As column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Event Closed Date Date The field has been renamed as Closed Date. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Closed Date column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Manufacturer Name N/A The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code in the Search Results > Manufacturer Name column for the Manufacturer-related subqueries. No updates to the business rules.
N/A N/A The following column names have been changed in the Substance Details QC Passed? subquery:
  • Excipient Role is renamed to Substance Role
  • Excipient Name to Substance Name
N/A
List of Active Ingredient Function Manufacturers Manufacturer Name Drop-down list The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code in the Enter Search Criteria > Manufacturer Name multi-select list. No updates to the business rules.
List of Active Ingredient Manufacturers Manufacturer Name Drop-down list The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code in the Enter Search Criteria > Manufacturer Name multi-select list. No updates to the business rules.
List of Active Ingredient Material Manufacturers Manufacturer Name Drop-down list The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code in the Enter Search Criteria > Manufacturer Name multi-select list. No updates to the business rules.
List of Component Manufacturers Manufacturer Name Drop-down list The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code in the Enter Search Criteria > Manufacturer Name multi-select list. No updates to the business rules.
List of Excipient Manufacturers Manufacturer Name Drop-down list The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code in the Enter Search Criteria > Manufacturer Name multi-select list. No updates to the business rules.
Excipient Name Selection list The Excipient Name multi-select list has been renamed to be Substance Role.
The following column names have been changed:
  • Excipient Role is renamed to Substance Role
  • Excipient Name to Substance Name
N/A
List of Package Set Manufacturers Manufacturer Name Drop-down list The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code in the Enter Search Criteria > Manufacturer Name multi-select list. No updates to the business rules.
List of PDS Manufacturers Manufacturer Name Drop-down list The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code in the Enter Search Criteria > Manufacturer Name multi-select list. No updates to the business rules.
List of Product Detail Sets Event Closed As Multi-select list The field has been renamed as Associations Closed As. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Associations Closed As column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Event Closed Date Date The field has been renamed as Closed Date. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Closed Date column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
List of Registrations with Excipients Excipient Name Selection list The following field names and column names have been changed:
  • Excipient Role is renamed to Substance Role
  • Excipient Name to Substance Name
N/A
Excipient Role Multi-select list
Table 3. Registered Document Analysis Queries
Query Name Field Name Field Type Description Business Rules
Registered Document Query Event Closed As Multi-select list The field has been renamed as Associations Closed As. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Associations Closed As column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Event Closed Date Date The field has been renamed as Closed Date. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Closed Date column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Table 4. Registration Planning and Tracking Queries
Query Name Field Name Field Type Description Business Rules
List of Applications with Products Application Name/Study Number Text Application Name field has been renamed as Application Name/Study Number. The Application Name/Study Number field is displayed on the List of Applications with the Products Query search criteria selection page and appears as a column on the Search Results page.
Applicable Standards Multi-select list The Applicable Standards value is now displayed as a concatenation of Applicable Standards Name - version in the Applicable Standards multi-select list.
Note: The hyphen is excluded when the version field is blank.
No updates to the business rules.
Application Type Multi-select list Business rules for the field have been changed. All application types are now available for selection in the Application Type multi-select list.
EU Class Drop-down list This field has been removed. N/A
EU Classification Rule Drop-down list This field has been removed. N/A
FDA Device Class Drop-down list This field has been removed. N/A
FDA Regulation Number Drop-down list This field has been removed. N/A
Global Medical Device Nomenclature (GMDN) Code Multi-select list The Global Medical Device Nomenclature (GMDN) Code value is now displayed as a concatenation of GMDN Code - GMDN Term Name in the Global Medical Device Nomenclature (GMDN) Code multi-select list.
Note: The hyphen is excluded when the GMDN Term Name field is blank.
No updates to the business rules.
Medical Device Link/Listing Text This field has been removed. N/A
UMDNS Code Multi-select list The UMDNS Code value is now displayed as a concatenation of UMDNS Code - UMDNS Description in the UMDNS Code multi-select list.
Note: The hyphen is excluded when the UMDNS Description field is blank.
No updates to the business rules.
List of Events with Application Properties Event Closed As Multi-select list The field has been renamed as Associations Closed As. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Associations Closed As column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Event Closed Date Date The field has been renamed as Closed Date. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Closed Date column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
List of Manufacturers From Data Administration Manufacturer Name Text The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code in the Search Results > Manufacturer Name column. No updates to the business rules.
List of Medical Device Products Applicable Standards Multi-select list The Applicable Standards value is now displayed as a concatenation of Applicable Standards Name - version in the Applicable Standards multi-select list.
Note: The hyphen is excluded when the version field is blank.
No updates to the business rules.
EU Class Drop-down list This field has been removed. N/A
EU Classification Rule Drop-down list This field has been removed. N/A
FDA Device Class Drop-down list This field has been removed. N/A
FDA Regulation Number Drop-down list This field has been removed. N/A
Global Medical Device Nomenclature (GMDN) Code Multi-select list The Global Medical Device Nomenclature (GMDN) Code value is now displayed as a concatenation of GMDN Code - GMDN Term Name in the Global Medical Device Nomenclature (GMDN) Code multi-select list.
Note: The hyphen is excluded when the GMDN Term Name field is blank.
No updates to the business rules.
Medical Device Link/Listing Text This field has been removed. N/A
UMDNS Code Multi-select list The UMDNS Code value is now displayed as a concatenation of UMDNS Code - UMDNS Description in the UMDNS Code multi-select list.
Note: The hyphen is excluded when the UMDNS Description field is blank.
No updates to the business rules.
List of Medical Device Products and Components Applicable Standards Multi-select list The Applicable Standards value is now displayed as a concatenation of Applicable Standards Name - version in the Applicable Standards multi-select list.
Note: The hyphen is excluded when the version field is blank.
No updates to the business rules.
EU Class Drop-down list This field has been removed. N/A
EU Classification Rule Drop-down list This field has been removed. N/A
FDA Device Class Drop-down list This field has been removed. N/A
FDA Regulation Number Drop-down list This field has been removed. N/A
Global Medical Device Nomenclature (GMDN) Code Multi-select list The Global Medical Device Nomenclature (GMDN) Code value is now displayed as a concatenation of GMDN Code - GMDN Term Name in the Global Medical Device Nomenclature (GMDN) Code multi-select list.
Note: The hyphen is excluded when the GMDN Term Name field is blank.
No updates to the business rules.
Medical Device Link/Listing Text This field has been removed. N/A
UMDNS Code Multi-select list The UMDNS Code value is now displayed as a concatenation of UMDNS Code - UMDNS Description in the UMDNS Code multi-select list.
Note: The hyphen is excluded when the UMDNS Description field is blank.
No updates to the business rules.
List of Pharmaceutical and Medical Device Products Applicable Standards Multi-select list The Applicable Standards value is now displayed as a concatenation of Applicable Standards Name - version in the Applicable Standards multi-select list.
Note: The hyphen is excluded when the version field is blank.
No updates to the business rules.
EU Class Drop-down list This field has been removed. N/A
EU Classification Rule Drop-down list This field has been removed. N/A
FDA Device Class Drop-down list This field has been removed. N/A
FDA Regulation Number Drop-down list This field has been removed. N/A
Global Medical Device Nomenclature (GMDN) Code Multi-select list The Global Medical Device Nomenclature (GMDN) Code value is now displayed as a concatenation of GMDN Code - GMDN Term Name in the Global Medical Device Nomenclature (GMDN) Code multi-select list.
Note: The hyphen is excluded when the GMDN Term Name field is blank.
No updates to the business rules.
Medical Device Link/Listing Text This field has been removed. N/A
UMDNS Code Multi-select list The UMDNS Code value is now displayed as a concatenation of UMDNS Code - UMDNS Description in the UMDNS Code multi-select list.
Note: The hyphen is excluded when the UMDNS Description field is blank.
No updates to the business rules.
List of Pharmaceutical and Medical Device Products and Components Applicable Standards Multi-select list The Applicable Standards value is now displayed as a concatenation of Applicable Standards Name - version in the Applicable Standards multi-select list.
Note: The hyphen is excluded when the version field is blank.
No updates to the business rules.
EU Class Drop-down list This field has been removed. N/A
EU Classification Rule Drop-down list This field has been removed. N/A
FDA Device Class Drop-down list This field has been removed. N/A
FDA Regulation Number Drop-down list This field has been removed. N/A
Global Medical Device Nomenclature (GMDN) Code Multi-select list The Global Medical Device Nomenclature (GMDN) Code value is now displayed as a concatenation of GMDN Code - GMDN Term Name in the Global Medical Device Nomenclature (GMDN) Code multi-select list.
Note: The hyphen is excluded when the GMDN Term Name field is blank.
No updates to the business rules.
Medical Device Link/Listing Text This field has been removed. N/A
UMDNS Code Multi-select list The UMDNS Code value is now displayed as a concatenation of UMDNS Code - UMDNS Description in the UMDNS Code multi-select list.
Note: The hyphen is excluded when the UMDNS Description field is blank.
No updates to the business rules.
List of Product Families Product Family Name Multi-select list The Product Family Name field has been reworked to be a multi-select list instead of a text field in the List of Product Families query. This change enables the active ingredients in the Substance Selection list to be filtered according to their association to the selected product families.
List of Products with Event and Product Registration Details Event Closed As Multi-select list The field has been renamed as Associations Closed As. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Associations Closed As column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Event Closed Date Date The field has been renamed as Closed Date. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Closed Date column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
List of Sequences with Application and Event Properties Event Closed As Multi-select list The field has been renamed as Associations Closed As. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Associations Closed As column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Event Closed Date Date The field has been renamed as Closed Date. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Closed Date column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Table 5. Entity History Queries
Entity Name Field Name Field Type Description Business Rules
Event Event Closed As Multi-select list The field has been renamed as Associations Closed As:
  • View Event Attributes page for the closed events.
  • Modify Event Attributes page, if the Closed checkbox is selected.
Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Associations Closed As column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Event Closed Date Date The field has been renamed as Closed Date. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Closed Date column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Product Applicable Standards Multi-select list The Applicable Standards value is now displayed as a concatenation of Applicable Standards Name - version in the Applicable Standards multi-select list.
Note: The hyphen is excluded when the version field is blank.
No updates to the business rules.
EU Class Drop-down list This field has been removed. N/A
EU Classification Rule Drop-down list This field has been removed. N/A
FDA Device Class Drop-down list This field has been removed. N/A
FDA Regulation Number Drop-down list This field has been removed. N/A
Global Medical Device Nomenclature (GMDN) Code Multi-select list The Global Medical Device Nomenclature (GMDN) Code value is now displayed as a concatenation of GMDN Code - GMDN Term Name in the Global Medical Device Nomenclature (GMDN) Code multi-select list.
Note: The hyphen is excluded when the GMDN Term Name field is blank.
No updates to the business rules.
Medical Device Link/Listing Text This field has been removed. N/A
UMDNS Code Multi-select list The UMDNS Code value is now displayed as a concatenation of UMDNS Code - UMDNS Description in the UMDNS Code multi-select list.
Note: The hyphen is excluded when the UMDNS Description field is blank.
No updates to the business rules.