Applicable IndRegulation Code
| Business Data Model Data Model |
| Description | The jurisdictional law that may be applicable for registering the study to a clinical trial registry. |
| Attributes | |
| Applicable Ind |
|
| Regulation Code |
|
| Relationship | |
 governingRelevantRegulation |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| 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 |
Regulation Code
| 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/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Relationship Details |
governingRelevantRegulation
| Description | |
| Is Identifying Relationship | false |
| Child Table | Relevant Regulation |
| Child Role Name | governedInterventionalStudyProtocolVersion |
| Child Multiplicity | ZERO_TO_MANY |
| Child Referential Integrity: On Delete | RESTRICT |
| Child Referential Integrity: On Insert | NONE |
| Child Referential Integrity: On Update | RESTRICT |
| Parent Table | Interventional Study Protocol |
| Parent Role Name | governingRelevantRegulation |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | RESTRICT |
| Parent Referential Integrity: On Update | RESTRICT |
| Business Data Model Data Model |