Receipt Date and TimeSubmission StatusSubmission Status Date and TimeSubmission Type
| Business Data Model Data Model |
| Description | A compilation of the contents of one or more submission units that supports a specific regulatory purpose or decision. For example: A request for approval to either market a product or to allow the applicant to start testing of a proposed product. In most cases, the compilation of the submission units is used to assess a product's quality, safety and effectiveness. |
| Attributes | |
| Receipt Date and Time |
|
| Submission Status |
|
| Submission Status Date and Time |
|
| Submission Type |
|
| Relationship | |
 describingSubmission |
|
| Dependencies | |
 NONE |
|
| Reverse Dependencies | |
| |
|
| Attribute Details |
Receipt Date and Time
| Description | The date (and time) on which the first submission unit is received by the regulatory authority. |
| 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 |
Submission Status
| Description | Specifies the phase in the lifecycle of the submission. For example: Active Withdrawn |
| 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 |
Submission Status Date and Time
| Description | The date and time when the status of a submission to an authorizing body is assigned. |
| 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 |
Submission Type
| Description | Specifies the kind of submission. For example: Original Supplement Annual report |
| 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 |
describingSubmission
| Is Identifying Relationship | false |
| Child Table | Submission |
| Child Role Name | describedProduct |
| 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 | Product |
| Parent Role Name | describingSubmission |
| 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 |