Nullification IndNullification ReasonReport Sub Type
| Business Data Model Data Model |
| Description | A study report that provides notification of an adverse event, product problem, or information that is relevant to either. A report typically includes causal association, management strategies, authorship, sender and receiver organizations, subject or study subject of adverse event, or name of product. For example: An expedited AE report - a report of a serious and unexpected adverse event that must be submitted within specific timeframes to the sponsor and regulatory agencies. |
| Attributes | |
| Nullification Ind |
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| Nullification Reason |
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| Report Sub Type |
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| Generalization | |
 R_1261 |
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| Dependencies | |
 NONE |
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| Reverse Dependencies | |
| |
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| Attribute Details |
Nullification Ind
| Description | Specifies whether the report cancels a previously sent adverse event. |
| 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 |
Nullification Reason
| Description | Specifies why the adverse event report is nullified. |
| 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 |
Report Sub Type
| Description | Specifies a further classification of report type. For example: An Adverse Event Report would map to Document Type Code and the Safety Report Sub Type Code would map to a 7-day AE 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 |
| Generalization Details |
R_1261
| Supertype | Study Report |
| Subtype | Safety Report |
| Transform As | TABLE |
| Business Data Model Data Model |