Applicable IndEffective From DtEffective To DtLoad Info SkRegulation Code SkSource Code SkStudy Protocol SkTenant SkValid From TsValid To Ts
| Atomic Warehouse Model Data Model |
| Description | The jurisdictional law that may be applicable for registering the study to a clinical trial registry. |
| Attributes | |
| Applicable Ind |
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| Effective From Dt |
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| Effective To Dt |
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| Load Info Sk |
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| Regulation Code Sk |
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| Source Code Sk |
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| Study Protocol Sk |
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| Tenant Sk |
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| Valid From Ts |
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| Valid To Ts |
|
| Relationship | |
 Relevant Regulation_Study Protocol_FK |
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| Primary Key | |
 Relevant Regulation PK |
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| Dependencies | |
 |
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| Reverse Dependencies | |
 |
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| Attribute Details |
Applicable Ind
| Description | Specifies whether this study must be registered as required by applicable laws. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| 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 |
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 |
Regulation Code Sk
| Description | A coded value specifying a regulation that requires the study to be registered. For Example: US Food and Drug Administration regulation under section 351 of the Public Health Service Act or any of the following sections of the Federal Food, Drug and Cosmetic Act: 505, 510(k), 515, 520(m), and 522. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER] |
| Is Part Of PrimaryKey | true |
| Is Required | true |
| 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 |
Study Protocol 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 |
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 |
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 |
Relevant Regulation_Study Protocol_FK
| Is Identifying Relationship | true |
| Child Table | Relevant Regulation |
| 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 | Study Protocol |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Primary Key Details |
Relevant Regulation PK
| Key Attribute | Study Protocol Sk |
| Key Attribute | Regulation Code Sk |
| Key Attribute | Valid From Ts |
| Atomic Warehouse Model Data Model |