D2 Submission Registration Form
The Submission 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 Name | application_description | The Application Name is prefixed with the Application Code and suffixed with the Product Family Code. Application Code and Application Name will be separated with a hyphen. Value is inherited in D2. |
| Countries (defined as CMS) | concerned_member_states | Value is inherited in D2.
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. Concerned Member State 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 , D2 still keeps the Country value. |
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| 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:
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| Data Administration: Substance Values | Active Ingredient INN | inn_names | If a Substance is updated in Data Administration that corresponds to an Active Ingredient used within a Product Family, the value is inherited and the Submission Registration Form is updated. |
| Compound Number | product_compound_id | If a Substance is updated in Data Administration that corresponds to an Active Ingredient used within a Product Family, the value is inherited and the Submission 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. |
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| Molecular Formula | product_chemical_names | If a Substance is updated in Data Administration that corresponds to an Active Ingredient used within a Product Family, the value is inherited and the Submission Registration Form is updated. | |
| 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. |
| PDS Country | Country Trade Name | product_trade_name | For each Product within the Product Family, a new row will be created on the Drug Product tab populating the Trade Names within D2. This will occur for nodes in all the statuses.
Value is inherited in D2. If the Trade Name is updated in Data Administration in Calyx RIM, a new row is created in D2 and Trade Name is updated. D2 keeps the old record and updates the new record in a new row. If the Trade Name is updated for the Country in the PDS, a new row is created in D2 and Trade Name is updated for that Country. D2 keeps the old record and updates the new record in a new row. |
| 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 InSight 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. |
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| 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 statuses.
For each Product within the Product Family, a new row is created on the Drug Product tab populating the Indication within D2. The inherited value populates the row corresponding to the related product on the Drug Products tab of the Product/Project Info tab on the D2 properties Submission Registration Form. Where multiple values exist, a new row is created for every Indication/Intended Use. If the Indication Name is updated in Data Administration in Calyx RIM, a new row is created in D2 and Indication Name 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. |
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| 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 populates the row corresponding to the related product on the Drug Products tab of the Product/Project Info tab on the D2 properties Submission Registration Form. 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. |
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dosage_strength | For each Product within the Product Family, a new row will be created populating the Dosage Strength within D2.
The inherited value populates the row corresponding to the related product, within the Drug Products tab of the Product/Project Info tab on the D2 properties Submission Registration Form. Product Strength Measure 1, Product Strength Unit 1, Product Strength Measure 2, and Product Strength Unit 2 must be concatenated (as is shown on the view Product page) and added to Documentum D2. Where a slash ('/') is included, this must be translated to a hyphen. 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. |
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| Product Family | Product Family Code | product_code | Value is inherited in D2. |
| Generic Name | product_generic_name | Value is inherited in D2. | |
| Sequence | Filing Type | submission_type | N/A |
| Sequence Code | submission_number | N/A | |
| Sequence Status | submission_status | N/A | |
| Sequence Status Date | submission_date | N/A | |
| Sequence Name | submission_name | Sequence Name is displayed in the Submission Name field in D2. | |
| Event | Event Name | event_name | If the Event Name is displayed as selected Event Name in the Sequence entity, then the corresponding Event Name is displayed in the
event_name field in D2.
If more than one Event is associated with the Sequence in Calyx RIM, a new row is created for every Event Name in D2. When an Event Name that is associated with a Sequence in Calyx RIM is updated, the Event Name in D2 is also updated. If Event(s) are disassociated from the Sequence in Calyx RIM, Event Name information still exists in D2. |
| Event Code | event_code | If the Event Name is displayed as selected Event Name in the Sequence entity, then Event Code is displayed in the
event_code field in D2.
When an Event Code that is associated with a Sequence in Calyx RIM is updated, the Event Code in D2 is also updated. If Event(s) are disassociated from the Sequence in Calyx RIM, Event Code information still exists in D2. |
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| Event Type | event_type | If the Event Name is displayed as selected Event Name in the Sequence entity in
Calyx RIM, Event Type is displayed in the
event_type field in D2.
When an Event Type that is associated with a Sequence in Calyx RIM is updated, the Event Type in D2 is also updated. If Event(s) are disassociated from the Sequence in Calyx RIM, Event Type information still exists in D2. If an Event Type is updated in Data Administration in Calyx RIM, a new row is created and Event Type is updated in D2. D2 keeps the old record and updates the new record in a new row. |
- 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.