Calyx RIM Administration

D2 Project Registration Form

The Project 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
Component Active Ingredient	Active Ingredient	drug_substance	Based on the Active Ingredients associated to the Product Family. 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.
PDS Active Ingredient	Active Ingredient Manufacturer	drug_substance_manufacturer	The value populates the row corresponding to the related product within the Drug Substance tab of the D2 properties (Project Registration Form). For each Component Active Ingredient within the Product Family, a new row will be created on the Drug Substance tab populating the Component Active Ingredient Manufacturer within D2. Semicolon separated list of manufacturers will be found under the Component > Active Ingredient > Manufacturer node within the Calyx RIM PDS node. This will occur for nodes of all statuses. While there is no Function under the Manufacturer node, you can configure the location within the PDS to pull the manufacturer from and define a related function if that node has functions. When multiple values exist, a new row is created for every Manufacturer in D2. 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 Indication/Intended Use	Indications/Intended Use	indication	The Project Registration Form is updated for each PDS associated to the Product through an Application (regardless of Country), for nodes of all statuses. The value populates the row corresponding to the related product on the Drug Product tab of the D2 properties (Project Registration Form). Where multiple values exist, a new row is created for every Indication/Intended use in D2. For each Product within the Product Family, a new row will be created on the Drug Product tab populating the Indication within D2. If the Indication is updated in Data Administration in Calyx RIM, a new row is created in D2 and Indication value is updated. D2 keeps the old record and updates the new record in a new row. If the Indication is deleted from the PDS, D2 still keeps the Indication information.
PDS Manufacturer	Manufacturer (Name)	drug_product_manufacturer	From the PDS > Manufacturer node, get the Manufacturer if the associated Function is named as 'Manufacture'. The related function name is configurable. Configure the location within the PDS to pull the manufacturer from. For each Product within the Product Family, a new row is created on the Drug Product tab populating the Manufacturer (Name) within D2. The value populates the row corresponding to the related product on the Drug Product tab of the D2 properties (Project Registration Form). This occurs for nodes of all statuses. When multiple values exist, a new row is created for every Manufacturer (Name) in D2. 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	Row is populated per product in Calyx RIM, with: <Product Code><space><Full Product Name> Example: 123 Pharmaceutical The field name mapping is configurable. If the Product Code or Product Name is updated in the Product Attribute page in Calyx RIM, a new row is created in D2 and Product information is updated. D2 keeps the old record and updates the new record in a new row.
	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. A new row will exist for every Dosage Form of the product. If the Product Dosage Form is updated in the Product Attribute page in Calyx RIM, a new row is created for the corresponding Product in D2 and Dosage Form is updated. D2 keeps the old record and updates the new record in a new row. If the Product Dosage Form is updated in Data Administration in Calyx RIM, a new row is created in D2 and Product Dosage Form is updated. D2 keeps the old record and updates the new record in a new row.
	Product Route of Administration	route_of_admin	For each Product within the Product Family, a new row is created on the Drug Product tab populating the Route of Administration within D2. A new row will exist for every Route of Administration for the product. If the Product Route of Administration is updated in Data Administration in Calyx RIM, a new row is created in D2 and Route of Administration is updated. D2 keeps the old record and updates the new record in a new row. If the Product Route of Administration is deleted from the Product Attribute page in Calyx RIM, D2 still keeps the Route of Administration value.
	Product Strength	dosage_strength	For each Product within the Product Family, a new row is created populating the Dosage Strength within D2. Product Strength Measure 1, Product Strength Unit 1 is concatenated and displayed in one row. The Product Strength Measure 2, Product Strength Unit 2 is concatenated and displayed in a separate row for every product. If the Product Strength information (Product Strength Value, Product Strength Unit) is updated in the Product Attribute page in Calyx RIM, a new row is created in D2 and Product Strength information is updated. D2 keeps the old record and updates the new record in a new row. If the Product Strength Unit Value is updated in Data Administration in Calyx RIM, a new row is created in D2 and Product Strength Unit Value is updated. D2 keeps the old record and updates the new record in a new row.
Product Family	Family Name	project_name	One Project Registration Form is created per Product Family.
Product Family	Family Code	product_code	One Project Registration Form is created per Product Family.

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.

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D2 Project Registration Form

The Project 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
Component Active Ingredient	Active Ingredient	drug_substance	Based on the Active Ingredients associated to the Product Family. 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.
PDS Active Ingredient	Active Ingredient Manufacturer	drug_substance_manufacturer	The value populates the row corresponding to the related product within the Drug Substance tab of the D2 properties (Project Registration Form). For each Component Active Ingredient within the Product Family, a new row will be created on the Drug Substance tab populating the Component Active Ingredient Manufacturer within D2. Semicolon separated list of manufacturers will be found under the Component > Active Ingredient > Manufacturer node within the Calyx RIM PDS node. This will occur for nodes of all statuses. While there is no Function under the Manufacturer node, you can configure the location within the PDS to pull the manufacturer from and define a related function if that node has functions. When multiple values exist, a new row is created for every Manufacturer in D2. 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 Indication/Intended Use	Indications/Intended Use	indication	The Project Registration Form is updated for each PDS associated to the Product through an Application (regardless of Country), for nodes of all statuses. The value populates the row corresponding to the related product on the Drug Product tab of the D2 properties (Project Registration Form). Where multiple values exist, a new row is created for every Indication/Intended use in D2. For each Product within the Product Family, a new row will be created on the Drug Product tab populating the Indication within D2. If the Indication is updated in Data Administration in Calyx RIM, a new row is created in D2 and Indication value is updated. D2 keeps the old record and updates the new record in a new row. If the Indication is deleted from the PDS, D2 still keeps the Indication information.
PDS Manufacturer	Manufacturer (Name)	drug_product_manufacturer	From the PDS > Manufacturer node, get the Manufacturer if the associated Function is named as 'Manufacture'. The related function name is configurable. Configure the location within the PDS to pull the manufacturer from. For each Product within the Product Family, a new row is created on the Drug Product tab populating the Manufacturer (Name) within D2. The value populates the row corresponding to the related product on the Drug Product tab of the D2 properties (Project Registration Form). This occurs for nodes of all statuses. When multiple values exist, a new row is created for every Manufacturer (Name) in D2. 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	Row is populated per product in Calyx RIM, with: <Product Code><space><Full Product Name> Example: 123 Pharmaceutical The field name mapping is configurable. If the Product Code or Product Name is updated in the Product Attribute page in Calyx RIM, a new row is created in D2 and Product information is updated. D2 keeps the old record and updates the new record in a new row.
	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. A new row will exist for every Dosage Form of the product. If the Product Dosage Form is updated in the Product Attribute page in Calyx RIM, a new row is created for the corresponding Product in D2 and Dosage Form is updated. D2 keeps the old record and updates the new record in a new row. If the Product Dosage Form is updated in Data Administration in Calyx RIM, a new row is created in D2 and Product Dosage Form is updated. D2 keeps the old record and updates the new record in a new row.
	Product Route of Administration	route_of_admin	For each Product within the Product Family, a new row is created on the Drug Product tab populating the Route of Administration within D2. A new row will exist for every Route of Administration for the product. If the Product Route of Administration is updated in Data Administration in Calyx RIM, a new row is created in D2 and Route of Administration is updated. D2 keeps the old record and updates the new record in a new row. If the Product Route of Administration is deleted from the Product Attribute page in Calyx RIM, D2 still keeps the Route of Administration value.
	Product Strength	dosage_strength	For each Product within the Product Family, a new row is created populating the Dosage Strength within D2. Product Strength Measure 1, Product Strength Unit 1 is concatenated and displayed in one row. The Product Strength Measure 2, Product Strength Unit 2 is concatenated and displayed in a separate row for every product. If the Product Strength information (Product Strength Value, Product Strength Unit) is updated in the Product Attribute page in Calyx RIM, a new row is created in D2 and Product Strength information is updated. D2 keeps the old record and updates the new record in a new row. If the Product Strength Unit Value is updated in Data Administration in Calyx RIM, a new row is created in D2 and Product Strength Unit Value is updated. D2 keeps the old record and updates the new record in a new row.
Product Family	Family Name	project_name	One Project Registration Form is created per Product Family.
Product Family	Family Code	product_code	One Project Registration Form is created per Product Family.

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.