In this example, the sponsor defined a top-level "Analysis Data Class" categorization, with one or more sub-categorizations for each of the data class categories. In this list, categorization labels are shown in bold and category labels are shown in italics.:
- Analysis Data Class
- Subject-level
- Subject-level Data Type (sub-categorization of "Subject-level")
- Demographics
- Subject-level Data Type (sub-categorization of "Subject-level")
- Events
- Events Data Type (sub-categorization of "Events")
- Adverse Events
- Clinical Events
- Disposition
- Events Analysis Type (sub-categorization of "Events")
- Occurrence
- Time-to-Event
- Events Data Type (sub-categorization of "Events")
- Findings
- Findings Data Type (sub-categorization of "Findings")
- Vital Signs
- Laboratory Tests
- Findings Analysis Type (sub-categorization of "Findings")
- Change from Baseline
- Shift Table
- Findings Data Type (sub-categorization of "Findings")
- Subject-level
This categorization and its sub-categorizations are represented—with identifier values assigned form both categorizations and categories—in the reporting event's analysisOutputCategorizations attribute:
analysisOutputCategorizations:
- id: Catn_02_DClass
label: Analysis 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_05_EvtAType
label: Events Analysis Type
categories:
- id: Catn_05_EvtAType_1_Occ
label: Occurrence
- id: Catn_05_EvtAType_2_Tte
label: Time-to-Event
- 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
- id: Catn_07_FndAType
label: Findings Analysis Type
categories:
- id: Catn_07_FndAType_1_Chg
label: Change from Baseline
- id: Catn_07_FndAType_2_Sft
label: Shift Table
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:
- The "Summary of Age by Treatment" analysis was categorized as:
- "Population Description" (Analysis Data Class) and
- "Demographics" (Subject-level Data Type).
- The "Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs" output was categorized as:
- "Findings" (Analysis Data Class),
- "Vital Signs" (Findings Data Type), and
- "Shift Table" (Findings Analysis Type).
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
- Catn_07_FndAType_2_Sft
...