Calyx RIM 7.0 Data Migration Documentation

Calyx RIM 7.0 Data Migration: Entities Updates

The Calyx RIM 7.0 database migration provides the changes related to Product Family Decoupling Entities Updates.

Product Family Attributes Changes

The changes in this table are provided for each of the Product Family Type Attributes windows based on the preparation for the future Data Module updates, and updates provided in the current release, for the relationship between an Application and a Product Family:

Flu Vaccine, Pharmaceutical, Veterinary Pharmaceutical-Medical Device Medical Device Action
Product Family Type Product Family Type Product Family Type Renamed to Family Type
Family Code Family Code Family Code Non-mandatory
Product Family Status Product Family Status Product Family Status Non-mandatory, Hidden
Product Family Status Date Product Family Status Date Product Family Status Date Non-mandatory, Hidden
PSUR Due Date PSUR Due Date - Hidden
PSUR Data Lock Date PSUR Data Lock Date - Hidden
Generic Name Generic Name - Hidden
ATC Last Updated ATC Last Updated - Deleted
Therapeutic Area Therapeutic Area - Hidden
Therapeutic Classes Therapeutic Classes - Hidden
Development Sponsor Development Sponsor - Hidden
Approved Trade Names Approved Trade Names Approved Trade Names Hidden
- Division Division Hidden
- - International Birth Date Hidden
Note: To be able to see Hidden fields, the meta overrides file should be updated accordingly. By default, these values in Data Administration are not hidden: Division Values, Product Family Status Values, Therapeutic Area Values, Therapeutic Class Value, but they are invisible on the Product Family entity. When the meta override file is configured, you will be able to see and use these fields for the Product Family entity.

The Create Application icon is no longer available on the Application tab on the Product Family Attributes screen. See Application section for more details regarding Application creation.

Application Changes

In Calyx RIM 7.0 the decoupling of Product Family from Application changes the relationship between Product Family and Application. A Product Family connection with an Application is now through the Product association. This is necessary to implement the change in determining the Application unicity in the system.

The unicity of an Application is the combination of the Application Name and Application Code system-wide in Calyx RIM 7.0. For Clinical Trial Applications, the unicity is a combination of the Study Number and Application Code.

An available migration script will identify Applications in the system that do not comply with the new Application uniqueness rule. The script can be executed more than once.

For records that do not comply with the new Application uniqueness rule, there is a migration script that will resolve the duplicate names by appending the Application Name with either the Product Family Name or the Product Family Code. In support of the appended Application Names, the database field size for the Application Name is increased from VARCHAR2(500) to VARCHAR2(2000).

There is also a migration script that identifies Application Names that are updated as a result of running the script.

This table describes the migration script that identifies Applications that do not comply with the Application unicity for Calyx RIM 7.0 (output is in .xlsx format):

Table 1. Report Column Definition
rpt_migration_application_duplicate_.sql
Report Column Value
PRODUCT FAMILY NAME Displays the Product Family Name
PRODUCT FAMILY CODE Displays the Product Family Code
APPLICATION NAME Displays the Application Name
APPLICATION CODE Displays the Application Code
APPLICATION STUDY NUMBER Displays Study Number for CTA Application Type
APPLICATION TYPE Displays Application Type
PROCEDURE Displays Application Procedure Type
REVIEWING COUNTRY Displays the Application Reviewing Country
Note: To update Applications that do not comply with the Application uniqueness rule, the script provides the option to append the Application Name with either the Product Family Name OR the Product Family Code. The choice of appending with Product Family Name or Product Family Code can be defined in the script.

This table describes the migration script that identifies Applications that do not comply with the Application names that have been updated to comply with the Application unicity rule.

Table 2. Report Column Definition
rpt_migration_application_uniquness.sql
Report Column Value
PRODUCT FAMILY NAME Displays the Product Family Name
PRODUCT FAMILY CODE Displays the Product Family Code
APPLICATION NAME Displays the Application Name that has been updated as a result of running the migration script
APPLICATION CODE Displays the Application Code
APPLICATION STUDY NUMBER Displays Study Number for CTA Application Type
APPLICATION TYPE Displays Application Type
PROCEDURE Displays Application Procedure Type
REVIEWING COUNTRY Displays the Application Reviewing Country

Create Application Wizard Changes

In Calyx RIM 7.0, you can create an Application from the Wizards menu, for example with the Create Application wizard.

These changes apply to the wizard:
  • The Product Family Type field is deleted.
  • The Family Name field is deleted.
  • The Associated Products selection is mandatory:
    • Additional columns are added to the Product Selection widget:
      • Family Type
      • Family Name
      • Family Code

Product Changes

The Product Family decoupling requires the association of at least one Product with an Application. This means Calyx RIM Publishers will need to have access to Products. For the users with SPT, ELP, and PRP licenses, the following permissions can be set up in Security Administration for Calyx RIM 7.0:
  • Read/Write/Admin access to Product
  • Home page access to Product Family

As part of the migration there is a migration script to identify Applications without a Product. This script can be executed more than once.

A migration script is provided that automatically creates a Product and associates it with Applications that do not have at least one Product. An additional migration script is available that identifies Products that have been created and associated with Product Families and Applications as a result of the migration to v.7.0.

The Migration script to identify Applications with no Product (output is in .xlsx):

Table 3. Report Column Definition
rpt_migration_application_no_product.sql
Report Column Value
PRODUCT FAMILY NAME Displays the Product Family Name.
PRODUCT FAMILY TYPE Displays the Product Family Type.
PRODUCT FAMILY PRODUCT If a Product is associated with the Product Family, the Product Name is displayed.

If no Product is associated with the Product Family, the value is blank.

APPLICATION NAME Displays the Application Name.
APPLICATION STUDY NUMBER Displays Study Number for CTA Application Type.
APPLICATION CODE Displays Application Code.
APPLICATION TYPE Displays Application Type.
PROCEDURE Displays the Application Procedure Type.
REVIEWING COUNTRY Displays the Application Reviewing Country.
APPLICATION PRODUCT NAME Should be blank as this report identifies applications that do not have a Product association.
Migration Script to create a Product:
  • The script provides a prefix that can be company-defined, to prefix a value to the new Product name. The default prefix will be "MIG PROD_". A company defined prefix can be set in the script.
  • The Product Name will be populated with the value of the Product Family Name as follows:
    • Default: “MIG PROD_ <Product Family Name>”
    • Company Defined: <Pre-Fix>_<Product Family Name>
    • The status of the new Product created as a result of the migration will be set to Inactive which is the new display status mapped to the new internal system status of INACTIVE.
    • The newly created Product will be associated will all Applications for the PF that do not have at least one product already associated with it.
The migration script that identifies the new Products created. (output is .xlsx):
Table 4. Report Column Definition
rpt_migration_product.sql
Report Column Value
PRODUCT FAMILY NAME Displays the Product Family Name
PRODUCT FAMILY TYPE Displays the Product Family Type
PRODUCT FAMILY PRODUCT Displays the Product Name created as a result of the migration
APPLICATION NAME Displays the Application Name
APPLICATION STUDY NUMBER Displays Study Number for CTA Application Type
APPLICATION CODE Displays Internal System Status for Application Status value
APPLICATION TYPE Displays the Application Type
PROCEDURE Displays the Application Procedure Type
REVIEWING COUNTRY Displays the Application Reviewing Country
APPLICATION PRODUCT NAME Displays the Product Name created as a result of the migration
PRODUCT CREATION DATE Displays the date the product was created
PRODUCT CREATION TIME Displays the time the product was created
PRODUCT CREATED BY Displays the user that created the product
As part of capturing data within Calyx RIM 7.0 for Clinical Trials perspectives when you do not have Products associated with the Applications, and instead are using Comparators to track the clinical trial supplies, we recommend that you associate newly created Products with the CTA / IND Application Types for facilitating data integrity activities with the Investigational Medicinal Product(s) (IMP) included in the CTA process.

Entities Attributes and Tabs Updates for Product Family Changes

These changes apply for the described Entities:

Fields Changes Entity Name
Renamed: Product Family Type to Family Type Product (All Types)
Component
Component Active Ingredients
Component Reference Active Ingredients
Pharmaceutical Products
Modify Event-Product
CT Shared Date
Deleted: Product Family Type, Family Code, Family Name Application (All Types)
Application Country
Registration (both Types)
Event
Event Country
Event-Change Detail
Deleted: Family Code, Family Name Registration-Package Set
Registration-Package Set Country
Registration Full Product Presentation
Registration FPP Attachment
Registration Previous EV Codes
Sequence
Sequence Status Schedule
Reference (when created not under PF)
Task/Sub Task (when created not under PF)
The Products tab available on Application Attributes, Event Attributes, Registration Attributes is updated with additional columns:
  • Family Type.
  • Family Name, hyperlinked to a Product Family Attributes screen.
  • Family Code.

Wizards Changes

The following changes apply for the SEARCH functionality:

Changes Column Name Wizard Name
Renamed: Product Family Type to Family Type Global Project Plan (all flows), Notifications, XEVMPD Submission, Copy Event.
Product Family to Family Name
Deleted: Product Family Global Project Plan (all flows), Create Submission Plan, Bulk Update Events, Bulk Update Sequences, Create Sequence, Create References for the Project Events or Sequences.
Family Name Update Status, Import Assembly, Update Project Event Country Status, Calculate Project Dates, XEVMPD Submission, Copy Event.
Family Code Update Status, Copy Event.
Product Family Type Copy Event.
Product Family Name Copy Registration Attachment.
Added: Application Name Copy Task
Application Code Copy Task, Move Task, Global Project Plan (all types), XEVMPD Submission, Update Project Event Country Status, Calculate Project Dates, Bulk Update Events, Bulk Update Sequences, Associate Workflow to Events or Sequences, Create Sequence, Associate Change Detail(s) to Events, Leaf Updates for Assemblies, Copy Full Product Presentation, Copy Registration Attachment.

Queries Changes

The following changes apply for the SEARCH functionality:

Changes Column/Filters Column Name Report Name
Renamed: Product Family Type to Family Type List of Applications with Products, List of Events with Application Properties, List of Sequences with Application and Event Properties, PSUR World Wide Marketing Authorization Status Query, List of References - Rollup by Application, List of References - Rollup by Product Family, List of Tasks - Rollup by Application, List of CTA Applications, List of IND Applications, List of Products with Event and Product Registration Details, Applications Sent, Submitted, or Approved - Searched by INN or Active Ingredient, Applications Submitted and/or Approved and/or Terminated within a Date Range, List of Registrations with Application Properties, List of Events with Change Details, List of Application Countries with PDS Country and Registration Details, List of CTA Applications with PDS Details, List of Product Detail Sets, List of Product Detail Sets, List of Product Detail Sets, List of Registration Package Sets Withdrawn, Application History Query, Application QC Status History Report, Application QC Status History Report, Sunset Clause Marketing Status Query, 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, List of Species and Indications, List of Dose Schedules, List of Withdrawal Times, Labeled Indications Query, List of IND Applications with PDS Details, List of Registrations with Application Properties Query, List of Product Registrations with Application and Product Detail Properties, List of Registrations with Indications/Intended Use, List of Registrations with Excipients, List of Registrations with Active Ingredients, List of Registrations with Material, List of Registrations with Labeling, List of Registrations with Packaging, List of Registrations with Local Country Details, List of Application Countries with PDS Country and Registration Details, List of Events with Application Properties, List of Applications, List of References - Rollup by Application, List of References - Rollup by Product Family, Registered Document Query, List of Events with Application Properties, List of Applications.
Product Family to Family Name
Deleted: Product Family Status List of Application Countries with Registration Details, List of Product Families, List of Veterinary Products, List of Pharmaceutical Products and Components, List of Medical Device Products and Components, List of Application with Products, List of Product Families, List of Medical Device Products, List of Pharmaceutical and Medical Device Products, List of Pharmaceutical and Medical Device Products and Components, List of Veterinary Products and Components, List of Pharmaceutical Products and Components, List of Application Countries with PDS Country and Registration Details, List of Applications, List of Applications.
Therapeutic Area List of Application with Products, List of Product Families, List of Applications.
Therapeutic Class List of Applications with Products, List of Events with List of Application with Products, List of Product Families, List of Pharmaceutical Products, List of Veterinary Products, List of Veterinary Products, List of Pharmaceutical and Medical Device Products, List of Pharmaceutical Products and Components, List of Pharmaceutical Products and Components, List of Pharmaceutical and Medical Device Products and Components, List of Veterinary Products and Components, List of Pharmaceutical Products and Components.
PSUR Data Lock Date List of Application with Products, List of Product Families, List of Registrations with Application Properties, List of Registrations with Application Properties Query,List of Product Registrations with Application and Product Detail Properties, List of Registrations with Indications/Intended Use, List of Registrations with Excipients, List of Registrations with Active Ingredients, List of Registrations with Material, List of Registrations with Labeling, List of Registrations with Packaging, List of Registrations with Local Country Details, List of Applications, List of Applications.
Next PSUR Date List of Product Families
PSUR Due Date List of Product Families, List of Registrations with Application Properties, List of Registrations with Application Properties Query,List of Product Registrations with Application and Product Detail Properties, List of Registrations with Indications/Intended Use, List of Registrations with Excipients, List of Registrations with Active Ingredients, List of Registrations with Material, List of Registrations with Labeling, List of Registrations with Packaging, List of Registrations with Local Country Details, List of Applications, List of Applications.
Generic Name List of Product Families.
Product Family Status Date List of Pharmaceutical Products, List of Veterinary Products, List of Medical Device Products, List of Pharmaceutical and Medical Device Products, List of Pharmaceutical Products and Components, List of Pharmaceutical and Medical Device Products and Components, List of Veterinary Products and Components, List of Medical Device Products and Components, List of Pharmaceutical Products and Components, List of Application Countries with PDS Country and Registration Details.
Therapeutic Classes List of Pharmaceutical Products,List of Veterinary Products, List of Pharmaceutical and Medical Device Products.
Development Sponsor List of Product Families
Division List of Registrations for a Product Family, List of References Rollup by Product Family, List of Tasks Rollup by Product Family.