Entity Safety Report Detail

DescriptionA 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
Activity DttmActivity Dttm
Availability Sts Code SkAvailability Sts Code Sk
Change Reason TxtChange Reason Txt
Communication Mode Code SkCommunication Mode Code Sk
Completion Sts Code SkCompletion Sts Code Sk
Confidentiality Sts Code SkConfidentiality Sts Code Sk
Document Content Presentation Code SkDocument Content Presentation Code Sk
Document SkDocument Sk
Document Type Code SkDocument Type Code Sk
Due DtDue Dt
Effective From DtEffective From Dt
Effective To DtEffective To Dt
Load Info SkLoad Info Sk
Nullification IndNullification Ind
Nullification Reason Code SkNullification Reason Code Sk
Origination DttmOrigination Dttm
Physician Sign Off IndPhysician Sign Off Ind
Source Code SkSource Code Sk
Storage Sts Code SkStorage Sts Code Sk
Sub Type Code SkSub Type Code Sk
Tenant SkTenant Sk
Transcription DttmTranscription Dttm
Unique Document File NmUnique Document File Nm
Unique Document NumUnique Document Num
Valid From TsValid From Ts
Valid To TsValid To Ts

Relationship
Safety Report Detail_Document_FKSafety Report Detail_Document_FK

Primary Key
Safety Report Detail PKSafety Report Detail PK

Dependencies
 
 
 

Reverse Dependencies
 

Attribute Details

 Activity Dttm
DescriptionThe date and time identified in the document upon which patient related activities are performed.

For example: surgery, non-invasive procedure, consultation, examination dates and time etc.
Data TypeStandards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Availability Sts Code Sk
DescriptionIdentifies a document's availability for use in patient care.
For example:
Available for patient care
Deleted
Obsolete
Unavailable for patient care
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Change Reason Txt
DescriptionContains the reason for the change in status of the document.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Small [VARCHAR(50)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Communication Mode Code Sk
DescriptionSpecifies the form in which the report is transmitted.

For example:
Physically present
Over the telephone
Written communication
Electronic
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Completion Sts Code Sk
DescriptionIndicates the current completion status of the document.
For example:
Dictated
Documented
In Progress
Incomplete
Pre-authenticated
Authenticated
Legally authenticated
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Confidentiality Sts Code Sk
DescriptionIdentifies the status of the special confidentiality protection which should be applied to this information.
For example:
Very restricted
Restricted
Usual control
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Document Content Presentation Code Sk
DescriptionIndicates the method by which this document was obtained or originated.Conditional field which is required whenever the message contains content as presented in one or more observations.
For example:
Audio data
Formatted text
Image data
Scanned document
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Document Sk
DescriptionAnchor surrogate key for the Pharmacy Order data
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeytrue
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Document Type Code Sk
DescriptionClassifies the document by its type (as defined in the transcription system).
For example:
Autopsy report
Cardiodiagnostics
Consultation
Diagnostic imaging
Discharge summary
Emergency department report
History and physical examination
Operative report
Psychiatric consultation
Psychiatric history and physical examination
Procedure note
Progress note
Surgical pathology
Transfer summary
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Due Dt
DescriptionThe date and time on which the report is expected or scheduled to be submitted.
Data TypeStandards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Effective From Dt
DescriptionEstablishes a period where a set of attributes are true according to the business.
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Effective To Dt
DescriptionEnds a period of effectivity.
Data TypeStandards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Load Info Sk
DescriptionThe surrogate key of the load information entry describing the details regarding the loading of the row.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Nullification Ind
DescriptionSpecifies whether the report cancels a previously sent adverse event.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Nullification Reason Code Sk
DescriptionSpecifies why the adverse event report is nullified.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Origination Dttm
DescriptionThe date and time upon which the document was created (i.e. dictated, recorded, etc.).
Data TypeStandards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Physician Sign Off Ind
DescriptionSpecifies whether the physician has reviewed and signed off on a version of a report.
Data TypeStandards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Source Code Sk
DescriptionThe 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Storage Sts Code Sk
DescriptionIdentifies the storage status of the document.
For example:
Active
Active and archived
Archived (not active)
Purged
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Sub Type Code Sk
DescriptionSpecifies 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 TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Tenant Sk
DescriptionThe surrogate key of the entry identifying the legal owner of the data.
Data TypeStandards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKeyfalse
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Transcription Dttm
DescriptionThe date and time upon which the input was actually transcribed onto the document.
Data TypeStandards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Unique Document File Nm
DescriptionIndicates a reference to a website, ftp, file path or other location from which the document contents can be retrieved.
Data TypeStandards - Data Domains.ddm/Data Domains/Name Long [VARCHAR(255)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Unique Document Num
DescriptionIndicates the unique document identification number assigned by the sending system.
Data TypeStandards - Data Domains.ddm/Data Domains/Alphanumeric [VARCHAR(80)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Valid From Ts
DescriptionEstablishes 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 TypeStandards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKeytrue
Is Requiredtrue
Is Derivedfalse
Is Surrogate Keyfalse



 Valid To Ts
DescriptionEnds a period of validity.
Data TypeStandards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse

Relationship Details

 Safety Report Detail_Document_FK
Is Identifying Relationshiptrue
Child TableSafety Report Detail
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteNONE
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateNONE
Parent TableDocument
Parent MultiplicityONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertNONE
Parent Referential Integrity: On UpdateNONE

Primary Key Details

 Safety Report Detail PK
Key AttributeDocument Sk
Key AttributeValid From Ts