Calyx RIM Administration

D2 Regulatory Application Registration Form

The Regulatory Application Registration Form in the Documentum D2 system is created or updated when any of the following business rules are fulfilled.


LIQUENT InSight Entity	LIQUENT InSight Field	Field on D2 Form	Business Rules
Application	Application Code	application_num	The Application Number field is populated with the Application Code value. If the Application Code is updated in Calyx RIM, a new row is created in D2 and the Application Number value is updated. D2 keeps the old record and updates the new record in a new row.
	Application Status	application_status	N/A
	Application Type	application_type	N/A
	Countries	submission_country	Populated by the Reviewing Country for the Application.
	Countries (defined as CMS)	concerned_member_states	When the Procedure Type for the Application is linked to the External System Procedure Type Code `MRP` and `DCP`, the Concerned Member States field is populated on the Regulatory Application Registration Form. The Concerned Member States table is populated with the Health Authority and Application Code values. If the Country is updated in Data Administration in Calyx RIM, a new row is created in D2 and the Country value is updated. D2 keeps the old record and updates the new record in a new row. If the Country is deleted from the Application > Countries, D2 still keeps the Country value.
	Application Name	application_description (SDK: regulatoryForm)	The Application Name is prefixed with the Application Code and suffixed with the Product Family Code. Application Code and Application Name are separated with a hyphen. The value with this preferred combination appears for the RARF name in the `Doc List` section as well.
	Procedure Type	submission_procedure_type	When updated, a Procedure Type value in Calyx RIM contains the following text for D2 to acknowledge the type of procedure it is: When the External System Procedure Type Code is `CP`, the Procedure Type in D2 is set to Centralized. When the External System Procedure Type Code is `DCP`, the Procedure Type in D2 is set to Decentralized. When the External System Procedure Type Code is `MRP`, the Procedure Type in D2 is set to Mutual Recognition. When the External System Procedure Type Code is `NATIONAL`, the Procedure Type in D2 is set to National.
Data Admin: Country Values	Region	region	If a Country value is updated in Data Administration that corresponds to a Country used within an Application, the Regulatory Application Registration Form is updated. D2 Regions should be the regulatory region for the reviewing country only.
Data Admin: Country Values	Health Authority (Name)	health_authority	If a Country value updated in Data Administration corresponds to a Country used within an Application, the Regulatory Application Registration Form is updated. If a Country is associated with more than one Authority, a row is created for each unique combination of Country and Health Authority. If the Health Authority is updated for the Country in Data Administration in Calyx RIM, a new row is created in D2 and the Health Authority value is updated. D2 keeps the old record and updates the new record in a new row.
Data Admin: Substance Values	Active Ingredient INN	inn_names	If a Substance updated in Data Administration corresponds to an Active Ingredient used within a Product for the Application, the value is inherited and the Regulatory Application Registration Form is updated. If the INN is updated for the Substance in Data Administration in Calyx RIM, a new row is created in D2 and INN value is updated. D2 keeps the old record and updates the new record in a new row.
	Compound Number	product_compound_id	If a Substance is updated in Data Administration that corresponds to an Active Ingredient used within a Product for the Application, the value is inherited and the Regulatory Application Registration Form is updated. If the Compound Number is updated for the Substance in Data Administration in Calyx RIM, a new row is created in D2 and Compound Number is updated. D2 keeps the old record and updates the new record in a new row.
	Molecular formula	product_chemical_names	If a Substance is updated in Data Administration that corresponds to an Active Ingredient used within a Product for the Application, the value is inherited and the Regulatory Application Registration Form is updated. If the Molecular Formula is updated for the Substance in Data Administration in Calyx RIM, a new row is created in D2 and Product Chemical Name/Molecular Formula value is updated. D2 keeps the old record and updates the new record in a new row.
PDS Active Ingredient	Active Ingredient Manufacturer	drug_substance_manufacturer	Only the values from the Project Registration Form that are applicable to the Product on the Application are inherited. For each Active Ingredient within the Product Family, a new row is created on the Drug Substance tab populating the Active Ingredient Manufacturer within D2. This occurs for nodes of all statuses. If a Manufacturer Name is updated in Data Administration in Calyx RIM, a new row is created in D2 and Manufacturer Name is updated. D2 keeps the old record and updates the new record in a new row. If the Manufacturer is deleted from the PDS Active Ingredient entity in Calyx RIM, D2 still keeps the Manufacturer information.
PDS Country	Country Trade Name	product_trade_name	For each Product within the Product Family, a new row is created on the Drug Product tab populating the Trade Names within D2. This occurs for nodes of all statuses. Value is inherited in D2.
PDS Country	Country Name	product_trade_country	Value is inherited in D2.
PDS Manufacturer	PDS Manufacturer (Name)	drug_product_manufacturer	For each Product within the Product Family, a new row is created on the Drug Product tab populating the Manufacturer (Name) within D2. This occurs for nodes of all statuses. Only the values from the Project Registration Form that are applicable to the Product on the Application are inherited. If a Manufacturer Name is updated in Data Administration in Calyx RIM, a new row is created in D2 and Manufacturer Name is updated. D2 keeps the old record and updates the new record in a new row. If the Manufacturer is deleted from the PDS, D2 still keeps the Manufacturer information.
Product	Product Code - Full Product Name	external_product_name_dp	Value inherited from Project Registration Form.
	Active Ingredient	drug_substance	Only the values from the Project Registration Form that are applicable to the Product on the Application are inherited. For each Active Ingredient within the Product Family, a new row is created on the Drug Substance tab populating the Active Ingredient Name within D2. If a Substance Name is updated in Data Administration in Calyx RIM, a new row is created in D2 and Substance Name is updated. D2 keeps the old record and updates the new record in a new row.
	Indications/Intended Use	indication	The value in the Regulatory Application Registration Form is inherited for each PDS associated to the Product through an Application (regardless of Country) for nodes in all the statuses. For each Product within the Product Family, a new row is created on the Drug Product tab populating the Indication within D2. The value populates the row corresponding to the related product, on the Drug Products tab of the Product/Project Info tab on the D2 properties Regulatory Application Registration Form. Where multiple values exist, a new row is created for every Indication/Intended Use.
	Product Dosage Form	dosage_form	For each Product within the Product Family, a new row is created on the Drug Product tab populating the Dosage Form within D2. The inherited value is populated in the row corresponding to the related product on the Drug Products tab of the Product/Project Info tab on the D2 properties Regulatory Application Registration Form.
	Product Strength	dosage_strength	For each Product within the Product Family, a new row is created, populating the Dosage Strength within D2. The inherited value is populated in the row corresponding to the related product on the Drug Products tab of the Product/Project Info tab on the D2 properties Regulatory Application Registration Form.
Product Family	Family Name	project_name	The inherited value is used to create the Form hierarchy within D2.
	Family Code	product_code	The inherited value is used to create the Form hierarchy within D2.
	Generic Name	product_generic_name	Value is inherited in D2. If the Generic Name is updated for the Product Family in Calyx RIM, a new row is created in D2 and Generic Name is updated. D2 keeps the old record and updates the new record in a new row.

Tip:

Information deleted in Calyx RIM will continue to exist in D2 system.
If a field on an integrated Calyx RIM 6.2 entity is updated, and it does not correspond to a column in the grid in D2, the existing Form is updated.
If a field on and integrated Calyx RIM 6.2 entity is updated, and it corresponds to a column in the grid in D2, a new row is created keeping the old record in the D2 grid.

JavaScript must be enabled in order to use this site.Please enable JavaScript in your browser and refresh the page.

D2 Regulatory Application Registration Form

The Regulatory Application Registration Form in the Documentum D2 system is created or updated when any of the following business rules are fulfilled.


LIQUENT InSight Entity	LIQUENT InSight Field	Field on D2 Form	Business Rules
Application	Application Code	application_num	The Application Number field is populated with the Application Code value. If the Application Code is updated in Calyx RIM, a new row is created in D2 and the Application Number value is updated. D2 keeps the old record and updates the new record in a new row.
	Application Status	application_status	N/A
	Application Type	application_type	N/A
	Countries	submission_country	Populated by the Reviewing Country for the Application.
	Countries (defined as CMS)	concerned_member_states	When the Procedure Type for the Application is linked to the External System Procedure Type Code `MRP` and `DCP`, the Concerned Member States field is populated on the Regulatory Application Registration Form. The Concerned Member States table is populated with the Health Authority and Application Code values. If the Country is updated in Data Administration in Calyx RIM, a new row is created in D2 and the Country value is updated. D2 keeps the old record and updates the new record in a new row. If the Country is deleted from the Application > Countries, D2 still keeps the Country value.
	Application Name	application_description (SDK: regulatoryForm)	The Application Name is prefixed with the Application Code and suffixed with the Product Family Code. Application Code and Application Name are separated with a hyphen. The value with this preferred combination appears for the RARF name in the `Doc List` section as well.
	Procedure Type	submission_procedure_type	When updated, a Procedure Type value in Calyx RIM contains the following text for D2 to acknowledge the type of procedure it is: When the External System Procedure Type Code is `CP`, the Procedure Type in D2 is set to Centralized. When the External System Procedure Type Code is `DCP`, the Procedure Type in D2 is set to Decentralized. When the External System Procedure Type Code is `MRP`, the Procedure Type in D2 is set to Mutual Recognition. When the External System Procedure Type Code is `NATIONAL`, the Procedure Type in D2 is set to National.
Data Admin: Country Values	Region	region	If a Country value is updated in Data Administration that corresponds to a Country used within an Application, the Regulatory Application Registration Form is updated. D2 Regions should be the regulatory region for the reviewing country only.
Data Admin: Country Values	Health Authority (Name)	health_authority	If a Country value updated in Data Administration corresponds to a Country used within an Application, the Regulatory Application Registration Form is updated. If a Country is associated with more than one Authority, a row is created for each unique combination of Country and Health Authority. If the Health Authority is updated for the Country in Data Administration in Calyx RIM, a new row is created in D2 and the Health Authority value is updated. D2 keeps the old record and updates the new record in a new row.
Data Admin: Substance Values	Active Ingredient INN	inn_names	If a Substance updated in Data Administration corresponds to an Active Ingredient used within a Product for the Application, the value is inherited and the Regulatory Application Registration Form is updated. If the INN is updated for the Substance in Data Administration in Calyx RIM, a new row is created in D2 and INN value is updated. D2 keeps the old record and updates the new record in a new row.
	Compound Number	product_compound_id	If a Substance is updated in Data Administration that corresponds to an Active Ingredient used within a Product for the Application, the value is inherited and the Regulatory Application Registration Form is updated. If the Compound Number is updated for the Substance in Data Administration in Calyx RIM, a new row is created in D2 and Compound Number is updated. D2 keeps the old record and updates the new record in a new row.
	Molecular formula	product_chemical_names	If a Substance is updated in Data Administration that corresponds to an Active Ingredient used within a Product for the Application, the value is inherited and the Regulatory Application Registration Form is updated. If the Molecular Formula is updated for the Substance in Data Administration in Calyx RIM, a new row is created in D2 and Product Chemical Name/Molecular Formula value is updated. D2 keeps the old record and updates the new record in a new row.
PDS Active Ingredient	Active Ingredient Manufacturer	drug_substance_manufacturer	Only the values from the Project Registration Form that are applicable to the Product on the Application are inherited. For each Active Ingredient within the Product Family, a new row is created on the Drug Substance tab populating the Active Ingredient Manufacturer within D2. This occurs for nodes of all statuses. If a Manufacturer Name is updated in Data Administration in Calyx RIM, a new row is created in D2 and Manufacturer Name is updated. D2 keeps the old record and updates the new record in a new row. If the Manufacturer is deleted from the PDS Active Ingredient entity in Calyx RIM, D2 still keeps the Manufacturer information.
PDS Country	Country Trade Name	product_trade_name	For each Product within the Product Family, a new row is created on the Drug Product tab populating the Trade Names within D2. This occurs for nodes of all statuses. Value is inherited in D2.
PDS Country	Country Name	product_trade_country	Value is inherited in D2.
PDS Manufacturer	PDS Manufacturer (Name)	drug_product_manufacturer	For each Product within the Product Family, a new row is created on the Drug Product tab populating the Manufacturer (Name) within D2. This occurs for nodes of all statuses. Only the values from the Project Registration Form that are applicable to the Product on the Application are inherited. If a Manufacturer Name is updated in Data Administration in Calyx RIM, a new row is created in D2 and Manufacturer Name is updated. D2 keeps the old record and updates the new record in a new row. If the Manufacturer is deleted from the PDS, D2 still keeps the Manufacturer information.
Product	Product Code - Full Product Name	external_product_name_dp	Value inherited from Project Registration Form.
	Active Ingredient	drug_substance	Only the values from the Project Registration Form that are applicable to the Product on the Application are inherited. For each Active Ingredient within the Product Family, a new row is created on the Drug Substance tab populating the Active Ingredient Name within D2. If a Substance Name is updated in Data Administration in Calyx RIM, a new row is created in D2 and Substance Name is updated. D2 keeps the old record and updates the new record in a new row.
	Indications/Intended Use	indication	The value in the Regulatory Application Registration Form is inherited for each PDS associated to the Product through an Application (regardless of Country) for nodes in all the statuses. For each Product within the Product Family, a new row is created on the Drug Product tab populating the Indication within D2. The value populates the row corresponding to the related product, on the Drug Products tab of the Product/Project Info tab on the D2 properties Regulatory Application Registration Form. Where multiple values exist, a new row is created for every Indication/Intended Use.
	Product Dosage Form	dosage_form	For each Product within the Product Family, a new row is created on the Drug Product tab populating the Dosage Form within D2. The inherited value is populated in the row corresponding to the related product on the Drug Products tab of the Product/Project Info tab on the D2 properties Regulatory Application Registration Form.
	Product Strength	dosage_strength	For each Product within the Product Family, a new row is created, populating the Dosage Strength within D2. The inherited value is populated in the row corresponding to the related product on the Drug Products tab of the Product/Project Info tab on the D2 properties Regulatory Application Registration Form.
Product Family	Family Name	project_name	The inherited value is used to create the Form hierarchy within D2.
	Family Code	product_code	The inherited value is used to create the Form hierarchy within D2.
	Generic Name	product_generic_name	Value is inherited in D2. If the Generic Name is updated for the Product Family in Calyx RIM, a new row is created in D2 and Generic Name is updated. D2 keeps the old record and updates the new record in a new row.

Tip:

Information deleted in Calyx RIM will continue to exist in D2 system.
If a field on an integrated Calyx RIM 6.2 entity is updated, and it does not correspond to a column in the grid in D2, the existing Form is updated.
If a field on and integrated Calyx RIM 6.2 entity is updated, and it corresponds to a column in the grid in D2, a new row is created keeping the old record in the D2 grid.