In this example, the sponsor had a specific operational need to categorize analyses and outputs according to the class and type of data included in each analysis or output. They therefore defined a top-level "Data Class" categorization with a "Data Type" subcategorization for each of the data class categories. This categorization and its subcategorizations are represented—with identifier values assigned for both categorizations and categories—in the reporting event's analysisOutputCategorizations attribute.
The categorization and category names represented here are only examples of ways in which a sponsor might choose to categorize, and subcategorize, the analyses or outputs included in a reporting event. While the categorizations chosen for this example are similar to Study Data Tabulation Model (SDTM) general observation classes and domains, this does not imply that analyses or outputs should be categorized by data class or data type as shown here. |
In these line captions, categorization labels are shown in bold and category labels are shown in italics.:
| Lines 2-4: | - Data Class (categorization)
| | Lines 5-7: | - Subject-level (category of "Data Class")
| | Lines 8-10: | - Subject-level Data Type (sub-categorization of "Subject-level")
| | Lines 11-12: | - Demographics (category of "Subject-level Data Type")
| | Lines 13-15: | - Events (category of "Data Class")
| | Lines 16-18: | - Events Data Type (sub-categorization of "Events")
| | Lines 19-20: | - Adverse Events (category of "Events Data Type")
| | Lines 21-22: | - Clinical Events (category of "Events Data Type")
| | Lines 23-24: | - Disposition (category of "Events Data Type")
| | Lines 25-27: | - Findings (category of "Data Class")
| | Lines 28-30: | - Findings Data Type (sub-categorization of "Findings")
| | Lines 31-32: | - Vital Signs (category of "Findings Data Type")
| | Lines 33-34: | - Laboratory Tests (category of "Findings Data Type")
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analysisOutputCategorizations:
- id: Catn_02_DClass
label: Data Class
categories:
- id: Catn_02_Dclass_1_Sbj
label: Subject-level
subCategorizations:
- id: Catn_03_SbjDType
label: Subject-level Data Type
categories:
- id: Catn_03_SbjDType_1_Dm
label: Demographics
- id: Catn_02_Dclass_2_Evt
label: Events
subCategorizations:
- id: Catn_04_EvtDType
label: Events Data Type
categories:
- id: Catn_04_EvtDType_1_Ae
label: Adverse Events
- id: Catn_04_EvtDType_2_Ce
label: Clinical Events
- id: Catn_04_EvtDType_3_Ds
label: Disposition
- id: Catn_02_Dclass_3_Fnd
label: Findings
subCategorizations:
- id: Catn_06_FndDType
label: Findings Data Type
categories:
- id: Catn_06_FndDType_1_Vs
label: Vital Signs
- id: Catn_06_FndDType_2_Lb
label: Laboratory Tests |
These categorization and category definitions could be represented in tabular form as shown in the following table where:
- Each instance of the AnalysisOutputCategory class is shown on a separate line, with values for the id and label attributes shown in the "category_id" and "category_label" columns, respectively.
- Attribute values each instance of the AnalysisOutputCategorization class are represented on each of the rows for the categories in the categorization.
- For subcategorizations, the id value of the parent category is shown in the "parent_category_id" column.
| id | label | parent_category_id | category_id | category_label |
|---|
| Catn_02_DClass | Data Class |
| Catn_02_Dclass_1_Sbj | Subject-level | | Catn_02_DClass | Data Class |
| Catn_02_Dclass_2_Evt | Events | | Catn_02_DClass | Data Class |
| Catn_02_Dclass_3_Fnd | Findings | | Catn_03_SbjDType | Subject-level Data Type | Catn_02_Dclass_1_Sbj | Catn_03_SbjDType_1_Dm | Demographics | | Catn_04_EvtDType | Events Data Type | Catn_02_Dclass_2_Evt | Catn_04_EvtDType_1_Ae | Adverse Events | | Catn_04_EvtDType | Events Data Type | Catn_02_Dclass_2_Evt | Catn_04_EvtDType_2_Ce | Clinical Events | | Catn_04_EvtDType | Events Data Type | Catn_02_Dclass_2_Evt | Catn_04_EvtDType_3_Ds | Disposition | | Catn_06_FndDType | Findings Data Type | Catn_02_Dclass_3_Fnd | Catn_06_FndDType_1_Vs | Vital Signs | | Catn_06_FndDType | Findings Data Type | Catn_02_Dclass_3_Fnd | Catn_06_FndDType_2_Lb | Laboratory Tests |
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In the same reporting event, both analyses and outputs were categorized by specifying one or more of the defined category identifier values in the categoryIds attribute:
| Lines 4-6: | Show that the "Summary of Age by Treatment" analysis was categorized as:- Subject-level (category of "Data Class")
- Demographics (category of "Subject-level Data Type")
| | Lines 12-15: | Show the "Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs" output was categorized as: - Findings (category of "Data Class")
- Vital Signs (category of "Findings Data Type")
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analyses:
- id: An03_01_Age_Summ_ByTrt
name: Summary of Age by Treatment
categoryIds:
- Catn_02_Dclass_1_Sbj
- Catn_03_SbjDType_1_Dm
...
...
outputs:
- id: Out14-3-3-1a
name: Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs
categoryIds:
- Catn_02_Dclass_3_Fnd
- Catn_06_FndDType_1_Vs
... |