Calyx RIM 6.2 Release Notes

Data Administration Tables: Calyx RIM 6.2

The following Data Administration tables, sections, or fields were added with Calyx RIM 6.2.

Data Administration Section: Application Maintenance

Data Administration Table Name Entity Affected Field Name Value List Description
Country Values > Health Authority N/A Organisation Identifier The Data Administration > Application Maintenance > Country Values > Health Authority attributes page has been enhanced by adding a new attribute named Organisation Identifier:
  • Field Type: text, non-mandatory
  • Field Size: 250 characters
  • Database Field Size: VARCHAR2(500)
Country Values > Region N/A N/A The IDMP Integration region of IDMP region type appears in the Region tab on the Country value attributes page for the following list of countries:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czech Republic
  • Denmark
  • Estonia
  • European Union
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom
Country Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the Country Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > Country RMS Values table are available for selection.
Procedure Type Values N/A IDMP Internal Procedure Code The Data Administration > Application Maintenance > Procedure Type Values attributes page has been enhanced by adding a new field named IDMP Internal Procedure Code:
  • Field Type: drop-down list
  • Values available for selection: CP, DCP, MRP, NATIONAL
Procedure Type Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the Procedure Type Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > Procedure Type RMS Values table are available for selection.
Region Type Values
  • Region Values
  • Country Values > Region
  • Update Applications wizard
  • Create Application wizard (the Region(s) read-only field)
  • Global Project Plan wizard:
    • Create New Applications Package Set Registration project
    • Clinical Trial project > Create New CTA and/or IND Application(s) flow
    • Clinical Trial project > Create New CTA Application(s) and Create New Event for Existing IND Application(s) flow
    • Clinical Trial project > Create New Event for Existing CTA and/or IND Application(s) flow
  • Create Timeline/Event Plan wizard
N/A The IDMP region type has been added. The default value is set to Active. This value is not available for modifications and cannot be deactivated.
Note: You can update the list of countries that are associated to the region of an IDMP type, or create a new region of an IDMP type, using the Region Values section.
  • In the Timeline/Event Plan wizard, the Region Type field has been updated to allow the selection an IDMP region type.
  • The Update Applications wizard has been enhanced to include an IDMP region type.
  • The Global Project Plan wizard has been enhanced to include an IDMP region type a search criteria.
  • The Create Application wizard, Application Attributes page, and Modify Application Attributes page have been updated to show the IDMP region type and a region of IDMP type in the Region(s) read-only field, if a country associated to such region has been selected as a Reviewing Country.
Region Values Country Values > Region N/A A new default region named IDMP Integration has been added. The default value is set to Inactive. The type of an IDMP Integration region is set to IDMP.
By default, the following list of countries belong to the IDMP Integration region:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czech Republic
  • Denmark
  • Estonia
  • European Union
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom

Data Administration Section: Other

Data Administration Table Name Entity Affected Field Name Value List Description
Concentration Measure Type Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the Concentration Measure Type Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > Concentration Measure Type RMS Values table are available for selection.
Denominator Unit Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the Denominator Unit Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > Denominator Unit RMS Values table are available for selection.
Language Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the Language Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > Language RMS Values table are available for selection.
Legal Basis Values
  • Package Set Registration
  • Data Administration > Application Maintenance > Legal basis Values
Package Set Registration > Legal Basis The Legal Basis Values table has been removed from the Data Administration > Application Maintenance section and is now included under the Data Administration > Other section. The table name has not been changed.
Legal Basis Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the Legal Basis Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > Legal Basis RMS Values table are available for selection.
MAH/Development Sponsor/Organisation Values N/A Organisation Identifier The Data Administration > Other > MAH/Development Sponsor/Organisation Values attributes page has been enhanced by adding a new attribute named Organisation Identifier:
  • Field Type: text, non-mandatory
  • Field Size: 250 characters
  • Database Field Size: VARCHAR2(500)
MAH/Development Sponsor/Organisation Values N/A Location Identifier To maintain the integration with Organisations management service (OMS) introduced by European Medicines Agency (EMA), the Data Administration > Other > MAH/Development Sponsor/Organisation Values attributes page has been updated with a new field named Location Identifier:
  • Field Type: text, non-mandatory
  • Field Size: 200 characters
  • Database Field Size: VARCHAR2(1000)
MAH/Development Sponsor/Organisation Values N/A Location Status To maintain the integration with Organisations management service (OMS) introduced by European Medicines Agency (EMA), the Data Administration > Other > MAH/Development Sponsor/Organisation Values attributes page has been updated with a new field named Location Status:
  • Field Type: drop-down list, non-mandatory
  • The values available for selection are [Select], Active, Inactive. [Select] is set by default.
Numerator Unit Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the Numerator Unit Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > Numerator Unit RMS Values table are available for selection.
Previous EV Code Values Full Product Presentation > Previous EV Code Code Type The Authorised Product option has been hidden from the Code Type drop-down list. The options available for selection are:
  • Approved Substance
  • Pharmaceutical Form
  • Rout of Administration

The field is not available for modifications once the Previous EV Code value is created and saved in Data Administration.

The Full Product Presentation > Previous EV Code field has been reworked to be the FPP Previous EV Codes tab on the Full Product Presentation Attributes page without using the values from the Data Administration > Other > Previous EV Code Values section.

The following set of rules apply to the FPP Previous EV Code > Previous EV Code field:
  • Field Type: text, required
  • Field Size: 60 characters
  • Database Field Size: VARCHAR2(100)
Unit of Measure Prefix Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the Unit of Measure Prefix Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > Unit of Measure Prefix RMS Values table are available for selection.

Data Administration Section Name: Product Detail Set Maintenance

Data Administration Table Name Entity Affected Field Name Value List Description
Compendial Designation/Source Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the Compendial Designation/Source Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > Compendial Designation/Source RMS Values table are available for selection.
Excipient Role Values Product Detail Set > Substance Detail N/A The Excipient Role Values table in the Data Administration > Product Detail Set Maintenance section has been renamed as Substance Role Values.
Manufacturer Values
  • PDS > Component > Active Ingredient > Manufacturer
  • PDS > Component > Active Ingredient > Manufacturing Process > Function > Manufacturer
  • PDS > Component > Substance > Manufacturer
  • PDS > Component > Substance > Manufacturing Process > Function > Manufacturer
  • PDS > Component > Manufacturing Process > Function > Manufacturer
  • PDS > Component > Function > Manufacturer
  • PDS > Manufacturing Process > Function > Manufacturer
  • PDS > Package Set > Function > Manufacturer
  • PDS > Package Set > Packaging > Manufacturer
  • PDS > Package Set > Component > Packaging > Manufacturer
  • Queries > Registration Planning and Tracking:
    • List of Manufacturers From Data Administration
  • Queries > Product Detail Management:
    • Application History Query
    • Application QC Status History Report
    • List of Active Ingredient Manufacturers
    • List of Active Ingredient Function Manufacturers
    • List of Active Ingredient Material Manufacturers
    • List of Excipient Manufacturers
    • List of PDS Manufacturers
    • List of Component Manufacturers
    • List of Package Set Manufacturers
  • Queries > Administration:
    • Entity Audit Trail
  • Global Project Plan wizard:
    • Add Active Ingredient Manufacturer flow
    • Add Active Ingredient Manufacturing Process Function Manufacturer flow
    • Add Substance Manufacturer flow
    • Add Substance Manufacturing Process Function Manufacturer flow
    • Add Component Function Manufacturer flow
    • Add Component Manufacturing Process Function Manufacturer flow
    • Add PDS Function Manufacturer flow
    • Add PDS Manufacturing Process Function Manufacturer flow
    • Add Package Set Function Manufacturer flow
    • Add Package Set Packaging Manufacturer flow
    • Add Package Set Component Packaging Manufacturer flow
  • Comparator > Suppliers multi-select list
Country The Country text field has been reworked to be a drop-down list with all active Country values from the Data Administration > Country Values table available for selection.
Manufacturer Values Manufacturer Name The uniqueness rule has been changed. Concatenation of the following values must be unique within the system:

Manufacturer Name + Address Line 1 + Country Code

Manufacturer Values N/A Country Code The Country Code drop-down list is no longer presented on the Create/Modify Manufacturer attributes page.
Manufacturer Values N/A Organisation Identifier The Data Administration > Product Detail Set Maintenance > Manufacturer Values attributes page has been enhanced by adding a new attribute named Organisation Identifier:
  • Field Type: text, non-mandatory
  • Field Size: 250 characters
  • Database Field Size: VARCHAR2(500)

Data Administration Section Name: Product Family Maintenance

Data Administration Table Name Entity Affected Field Name Value List Description
ATC Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the ATC Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > ATC RMS Values table are available for selection.

Data Administration Section Name: Product Maintenance

Data Administration Table Name Entity Affected Field Name Value List Description
Applicable Standards Values N/A Applicable Standard To maintain the version of standard, the Applicable Standards Values table has been updated to include the Version of Standard option.
Country Specific Detail Type Values Product > Country Specific Detail Product > Country Specific Detail > Country Specific Detail Type To maintain the specific detail type value of the country attribute, the Country Specific Detail Type Values table has been introduced. The Field Value Control drop-down list includes the options Controlled - Single Value, Controlled - Multiple Values, and User Entered.
Country Specific Detail Values Product > Country Specific Detail N/A
  • Country Specific Detail Type - All active Country Specific Detail Types are displayed.
  • Countries - A multi select field displaying all active countries.
  • Country Specific Value - This value is defined for the detail type when Field Value Control is set to Controlled in the Country Specific Detail Type. The field is hidden when Field Value Control is set to User Entered. The Country Specific Detail Value must be unique within the Country Specific Detail Type.
Dosage/Pharmaceutical Form Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the Dosage/Pharmaceutical Form Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > Dosage/Pharmaceutical Form RMS Values table are available for selection.
Device Classification Values N/A N/A This table has been removed.
FDA Regulation Number Values N/A N/A This table has been removed.
Global Medical Device Nomenclature (GMDN) Code Values N/A GMDN Term Name To identify medical devices, the Global Medical Device Nomenclature (GMDN) Code option has been introduced. The values for the GMDN Code and GMDN Term Name can be entered in their respective text fields.
Medical Device Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the Medical Device Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > Medical Device RMS Values table are available for selection.
Route of Administration Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the Route of Administration Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > Route of Administration RMS Values table are available for selection.
Universal Medical Device Nomenclature System (UMDNS) Code Values N/A UMDNS Code Values To identify, process, retrieve, transfer, and communicate data about medical devices, the UMDNS Code Values table has been introduced. The values for the UMDNS Code and UMDNS Description can be entered in their respective fields.

Data Administration Section Name: Registration Maintenance

Data Administration Table Name Entity Affected Field Name Value List Description
EMA Authorisation Status Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the EMA Authorisation Status Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > EMA Authorisation Status RMS Values table are available for selection.
Medicinal Product Type Values N/A RMS Term Name To maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service, the Medicinal Product Type Values table has been updated with a new drop-down list named RMS Term Name. The active values from SPOR Maintenance > Medicinal Product Type RMS Values table are available for selection.
Registration Status Values N/A Internal System Status On the Registration Maintenance > Registration Status Values attributes page in Data Administration, the Internal System Status field has been enhanced by adding a new internal status named APPROVED.

Data Administration Section Name: SPOR Maintenance

Data Administration Table Name Entity Affected Field Name Value List Description
  • ATC RMS Values
  • Compendial Designation/Source RMS Values
  • Concentration Measure Type RMS Values
  • Country RMS Values
  • Denominator/Numerator Unit RMS Values
  • Dosage/Pharmaceutical Form RMS Values
  • EMA Authorisation Status RMS Values
  • Language RMS Values
  • Legal Basis RMS Values
  • Medical Device RMS Values
  • Medicinal Product Type RMS Values
  • Procedure Type RMS Values
  • Route of Administration RMS Values
  • Unit of Measure Prefix RMS Values
N/A N/A Calyx RIM 6.2 introduces the SPOR Maintenance section in Data Administration. This section is designed to maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service. According to the roadmap designed by EMA the SPOR support starts with an introduction of OMS (Organisartions management service) and RMS (Referentials management service) components.
The active values from SPOR Maintenance sections can be successfully selected and deselected in the corresponding sections in Data Administration:
  • Application Maintenance > Country Values
  • Application Maintenance > Procedure Type Values
  • Other > Concentration Measure Type Values
  • Other > Denominator Unit Values
  • Other > Language Values
  • Other > Legal Basis Values
  • Other > Numerator Unit Values
  • Other > Unit of Measure Prefix Values
  • Product Detail Set Maintenance > Compendial Designation/Source Values
  • Product Family Maintenance > ATC Values
  • Product Maintenance > Dosage/Pharmaceutical Form Values
  • Product Maintenance > Medical Device Values
  • Product Maintenance > Route of Administration Values
  • Registration Maintenance > EMA Authorisation Status Values
  • Registration Maintenance > Medicinal Product Type Values

Data Administration Section Name: Workflow Management

Data Administration Table Name Entity Affected Field Name Value List Description
Workflow Management Full Product Presentation Available Entities If configured, the Full Product Presentation entity is available for selection in the Available Entities multi-select list when updating a workflow in the Workflow Management section.