Assessment Completion DateAssessment StatusExpected Resubmission DateIdentification NumRegulatory Assessment ReasonRegulatory Assessment TypeResult Designation
| Business Data 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. |
| Attributes | |
| Assessment Completion Date |
|
| Assessment Status |
|
| Expected Resubmission Date |
|
| Identification Num |
|
| Regulatory Assessment Reason |
|
| Regulatory Assessment Type |
|
| Result Designation |
|
| Relationship | |
 evaluatedSubmission |
|
| performingRegulatoryAuthority |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Assessment Completion Date
| 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 |
Assessment Status
| Description | Specifies the phase in the lifecycle of the assessment. For example: Pending Complete |
| 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 |
Expected Resubmission Date
| 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 |
Regulatory Assessment Reason
| Description | Specifies the rationale for a regulatory designation. |
| 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 |
Regulatory Assessment Type
| Description | Specifies the approval process used by the regulatory authority. For example: FDA's Center for Devices and Radiological Health (CDRH) Process FDA's Center for Drug Evaluation and Research (CDER) Process |
| 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 |
Result Designation
| 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/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Relationship Details |
evaluatedSubmission
| Is Identifying Relationship | true |
| Child Table | Regulatory Assessment |
| 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 | Submission |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
performingRegulatoryAuthority
| Is Identifying Relationship | true |
| Child Table | Regulatory Assessment |
| 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 Authority |
| Parent Multiplicity | ONE |
| Parent Referential Integrity: On Delete | NONE |
| Parent Referential Integrity: On Insert | NONE |
| Parent Referential Integrity: On Update | NONE |
| Business Data Model Data Model |