Page History

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 "Analysis Data Class" categorization

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	ARSP-12

, with one or more subcategorizations 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. Note that the

Note
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.:

Xfancy

class	rowcaps

Occurrence(category of "Events Analysis Type")Shift Table(category of "Findings Analysis Type")

Lines 2-4:

Analysis Data Class (categorization)

Lines 5-7:

- Subject-level (category of "Analysis 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 "Analysis 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:

- - Events Analysis Type (sub-categorization of "Events")

Lines 28-29:

Lines 30-31:

Time-to-Event
Jira
showSummary false
server Issue Tracker (JIRA)
serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key ARSP-11
(category of "Events Analysis Type")Lines 32-34:

- Findings(category of "Analysis Data Class")

Lines 3528-3730:

- - Findings Data Type (sub-categorization of "Findings")

Lines 3831-3932:

- - - Vital Signs(category of "Findings Data Type")

Lines 4033-4134:

- - - Laboratory Tests(category of "Findings Data Type")

Lines 42-44:

- - Findings Analysis Type (sub-categorization of "Findings")

Lines 45-46:

- - - Change from Baseline(category of "Findings Analysis Type")

Lines 47-48:

Code Block

title	YAML Example
linenumbers	true

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

These categorization and category definitions could be represented in tabular form as shown in the following table where:

...

Dataset2

id	label	parent_category_id	category_id	category_label
Catn_02_DClass	Analysis Data Class		Catn_02_Dclass_1_Sbj	Subject-level
Catn_02_DClass	Analysis Data Class		Catn_02_Dclass_2_Evt	Events
Catn_02_DClass	Analysis 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_05_EvtAType	Events Analysis Type	Catn_02_Dclass_2_Evt	Catn_05_EvtAType_1_Occ	Occurrence
Catn_05_EvtAType	Events Analysis Type	Catn_02_Dclass_2_Evt
Catn_05_EvtAType_2_Tte	Time-to-Event	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
Catn_07_FndAType	Findings Analysis Type	Catn_02_Dclass_3_Fnd	Catn_07_FndAType_1_Chg	Change from Baseline
Catn_07_FndAType	Findings Analysis Type	Catn_02_Dclass_3_Fnd	Catn_07_FndAType_2_Sft	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:

Xfancy

class	rowcaps

Lines 4-6:	Show that the "Summary of Age by Treatment" analysis was categorized as: Subject-level (category of "Analysis 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 "Analysis Data Class") Vital Signs(category of "Findings Data Type")Shift Table(category of "Findings Analysis Type")

Code Block

title	YAML Example
linenumbers	true

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
  ...

Page tree

Versions Compared

Old Version 13

New Version Current

Key