Completion DtEffective From DtEffective To DtExpected Resubmission DtIdentification NumLoad Info SkReason Code SkRegulatory Assessment SkResult Code SkSource Code SkStatus Code SkTenant SkType Code SkValid From TsValid To Ts
| Atomic Warehouse Model Data Model |
| Description | An evaluation of a submission by a regulatory body. For example: The FDA evaluates a submission for a new drug or device. |
| Relationship | |
 Regulatory Assessment Detail_Regulatory Assessment_FK |
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| Primary Key | |
 Regulatory Assessment Detail PK |
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| Dependencies | |
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| Reverse Dependencies | |
 |
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| Attribute Details |
Completion Dt
| Description | The date and time when the evaluation on a submission is completed by a regulatory body |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Effective From Dt
| Description | Establishes a period where a set of attributes are true according to the business. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date [DATE] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Effective To Dt
| Description | Ends a period of effectivity. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date [DATE] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Expected Resubmission Dt
| Description | The date on which resubmission to the regulatory body is expected. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Identification Num
| Description | A unique symbol that establishes identity of the regulatory assessment. For example: New Drug Application (NDA) number Investigational New Drug (IND) number Biologic License Application (BLA) Premarket Approval (PMA), 510K |
| Data Type | Standards - Data Domains.ddm/Data Domains/Alphanumeric [VARCHAR(80)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Load Info Sk
| Description | The surrogate key of the load information entry describing the details regarding the loading of the row. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Reason Code Sk
| Description | Specifies the rationale for a regulatory designation. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Regulatory Assessment Sk
| Description | Surrogate key for the anchor entity. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG] |
| Is Part Of PrimaryKey | true |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Result Code Sk
| Description | Specifies the regulatory designation made by the regulatory authority. For example: Approved Not approvable Approvable Complete response Cleared. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Source Code Sk
| Description | The origin of the data identifying the actual load source, vendor, manual key entry, or context of the data in a specific row in the database. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Status Code Sk
| Description | Specifies the phase in the lifecycle of the assessment. For example: Pending Complete |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Tenant Sk
| Description | The surrogate key of the entry identifying the legal owner of the data. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Type Code Sk
| Description | Identifies the actual type of the entry based on the entity type hierarchy defined in the business data model. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Valid From Ts
| Description | Establishes a period where a set of attributes are true in the source system. This would be populated with the transaction timestamp and would be used for the snapshot date. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP] |
| Is Part Of PrimaryKey | true |
| Is Required | true |
| Is Derived | false |
| Is Surrogate Key | false |
Valid To Ts
| Description | Ends a period of validity. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Relationship Details |
Regulatory Assessment Detail_Regulatory Assessment_FK
| Is Identifying Relationship | true |
| Child Table | Regulatory Assessment Detail |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | NONE |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | NONE |
| Parent Table | Regulatory Assessment |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Primary Key Details |
Regulatory Assessment Detail PK
| Key Attribute | Regulatory Assessment Sk |
| Key Attribute | Valid From Ts |
| Atomic Warehouse Model Data Model |