automation of sdtm generation & artifacts using cdisc 360 … · 2020-07-08 · automation of...
TRANSCRIPT
![Page 1: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/1.jpg)
Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards
Bhavin Busa (Vita Data Sciences), Jianhui [Jimmy] Zhao (Allergan)CDISC 360: The Journey So Far and the Road Ahead April 28, 2020
![Page 2: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/2.jpg)
Agenda1. Workstream 6 Introduction2. Current State: CDASH to SDTM Execution3. CDISC 360 Enriched Metadata4. Future State with Concept-based Standards : CDASH to SDTM
Execution5. Process Flow for CDISC 360 Proof of Concept6. Machine-readable Mapping Specifications7. Learnings so far
![Page 3: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/3.jpg)
Workstream 6 Introduction
![Page 4: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/4.jpg)
StudyMetadata
Library
CDISC 360 WorkstreamsWorkstream 1 - ENHANCE STANDARDS
Create concepts in knowledge graphs
Biomedical ConceptsAnalysis Concepts
Foundational Standards
Load into library
APIExtend API’s
Workstream 4 - DEFINE
Identify and select standards specification (Use Case 1)
Workstream 5 - BUILD
Configure study specification and create artifacts (Use Case 2)
Workstream 6 - EXECUTE
Automatically process and transform data (Use Case 3)
Workstream 2 - PUBLISH STANDARDS
Transform concepts in machine readable form
![Page 5: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/5.jpg)
Use Case 3 (Workstream 6): Execute
EDC ExtractDatabase
ADaM Creation
Analysis Results
Creation
ClinicalStudy
Reports
Operational Database
CDASH
Tabulation Datasets
SDTM
Analysis Datasets
ADaM
ePRO
EDC
eDT
eHR
ProcessStudy Data
Endpoints
TFL
Configured study
metadata
Automatic population of data into artifacts
5
![Page 6: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/6.jpg)
Workstream 6 & Task Team Leads
SDTM/ADaM Automation Task Team Leads
Bhavin Busa, Vita Data Sciences
TFL Automation Task Team Leads
Kaja Najumudeen,TalentMine
Jianhui Zhao, Allergan
Prasanna Murugesan, AstraZeneca
Stuart Malcolm, Frontier Science
Workstream 6 Lead
6
![Page 7: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/7.jpg)
![Page 8: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/8.jpg)
Current State - without Concept-based Standards
![Page 9: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/9.jpg)
9
Current State - without Concept-based Standards: CDASH to SDTM Execution
* Manual Process+ Manual or Semi-automated Execution
CRF* SDTM Specs*
SAS Programs+
SDTM Datasets+
SDTM Define & aCRF+
Submission+
XPT files, Define, aCRF, SDRG
Foundational Standards
Specify Build/Execute Report
![Page 10: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/10.jpg)
CDISC 360 Enriched Metadata
![Page 11: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/11.jpg)
Machine-readable CDISC 360 Enriched Metadata
Structural Conceptual
SemanticProcess
![Page 12: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/12.jpg)
Concept-based Standards: Biomedical Concept
• Triple Store
• Linking controlled terminology to the variable - standardize value level metadata
• Linked derivations and algorithms to variable(s)
• Include process metadata (ETL instructions)
• Machine readable definition of validation rules
Reference: ‘CDISC 360 - The Journey so Far and the Road Ahead’, Peter Van Reusel, 28th April 2020
![Page 13: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/13.jpg)
Linked Graph Model: Importing Concept-based Standards
Reference: ‘Study Design and Configuration using CDISC 360 concept-based standards’, Mikkel Traun, Nicolas de Saint Jorre, 28th April 2020
![Page 14: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/14.jpg)
Study Build of ODM.XML and Define.XML
Reference: ‘Study Design and Configuration using CDISC 360 concept-based standards’, Mikkel Traun, Nicolas de Saint Jorre, 28th April 2020
![Page 15: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/15.jpg)
ODM CRF Generated using Biomedical Concepts, Bindings, & Standards
15
ODM-based Vital Signs (VS) CRF Stylesheet rendering of ODM VS CRF
Reference: ‘CDISC Library: Integrating and Surfacing 360 Content’, Sam Hume, October 16, 2019
![Page 16: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/16.jpg)
Future State - with Concept-based Standards
![Page 17: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/17.jpg)
17
Future State - with Concept-based Standards: CDASH to SDTM Execution
ODM CRF Define XML SDTM Specs & aCRF
SDTM Programs
SDTM Datasets
Submission XPT files, Define,
aCRF, SDRG
Specify Build/Execute Report
Biomedical ConceptsFoundational Standards
= Automated Process
Study and Data Collection DesignersDesign
![Page 18: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/18.jpg)
Process Flow for CDISC 360 Proof of Concept (PoC)
![Page 19: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/19.jpg)
Process Flow for CDISC 360 PoC
CDASH to SDTM Execution
Des
ign
Def
ine
Bui
ldE
xecu
te
Biomedical ConceptsFoundational Standards
![Page 20: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/20.jpg)
Machine-readable Mapping Specifications
![Page 21: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/21.jpg)
Essential Elements for Machine-readable Mapping Specifications
We break down the essential elements in 2 dimensions to meet the 4 key aspects of the machine readability
Dimension 1• Source: location (library name), datasets, processing sequence
• Mapping: fields needed to describe how source transits to target
• Target: location (library name), datasets, processing sequence, attributes (label, class, structure, purpose, etc.)
Dimension 2• Dataset Level: Transit datasets from source to target
• Variable Level: Map variables from source to target
• Value Level: Map variables from source to target under different conditions
21
![Page 22: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/22.jpg)
Mapping Specifications: Dimension 1
22
Source Mapping Target
![Page 23: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/23.jpg)
Mapping Specifications: Dimension 2
23
Source Mapping Target
Dataset Level
Variable Level
Value Level
![Page 24: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/24.jpg)
Mapping Specifications: Dataset Level
24
data VS1;set CDASH.VS;/********variable level: Source Sequence = 1********/
run;
proc sort data=VS1; by SUBJID;proc sort data=CDAHS.DM OUT=DM2; by USUBJID;
data VS2;merge DM2(in=a) VS1(in=b);by USUBJID;if b;/********variable level: Source Sequence = 2********/
run;
proc sort data=VS4; by USUBJID VSTESTCD VISITNUM VSDTC;
run;
data SDTM.VS;set VS4;by USUBJID VSTESTCD VISITNUM VSDTC;
/********variable level: Source Sequence = 6********/
run;
❶❷
❸❹
❺
❶
❷
❸ ❹
❺
... Sequence 3, 4
![Page 25: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/25.jpg)
Mapping Specifications: Variable Level
25
data VS1;set CDASH.VS;
**** Variable level processing ;DOMAIN = 'VS';USUBJID = catx('.', STUDYID, SUBJID);VISITNUM = input(put(VISIT, $VISITNUM.), BEST.);
[origin = Predecessor, do nothing];
if not missing(VISDAT) thenVSDTC = put(VISDAT, E8601DA.);
else if not missing(VSDAT) thenVSDTC = put(VSDAT, E8601DA.);
if VISIT = "VISIT 2 (WEEK 0)" then VSBLFL = 'Y';run;
❶
❶❷
❸❹
❺❻
❷
❹
❸
❻
❺
❷
❺
❻
❷
❺
❻
![Page 26: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/26.jpg)
Mapping Specifications: Value Level
26
data VS3;set CDASH.VS;
if DIABP_VSPREF = 'Y' then do;VSTESTCD = 'DIABP';VSORRES = DIABP_VSORRES;VSORRESU = DIABP_VSORRESU;VSSTRESN = 'mmHg';VSSTRESN = INPUT(VSORRES, BEST.);VSSTRESC = PUT(VSSTRESN, 4.0);VSPOS = DIABP_VSPOS;OUTPUT;
end;
*** CONTINUTE ***;
if HEIGHT_VSPREF = 'Y' then do;VSTESTCD = 'HEIGHT';VSORRES = HEIGHT_VSORRES;VSORRESU = HEIGHT_VSORRESU;VSSTRESN = 'm';VSSTRESN = INPUT(VSORRES, BEST.);VSSTRESC = PUT(VSSTRESN, 4.0);OUTPUT;
end;run;
❶
❷
❶❷
![Page 27: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/27.jpg)
Learnings so farMachine-readable Metadata
![Page 28: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/28.jpg)
Machine-readable Metadata• CDISC 360 Enriched Metadata = Structural +
Conceptual + Semantic + Process [Key to Automation]o Content is part of the standards (CDISC library)
o ETL Metadata (mapping inference & derivation)
• System agnostic standards, concepts and elementso Can be consumed by any tool
o Organization can build an automation engine their own way
• Iterations are needed to learn and evolveo Strong workstream collaboration: CDISC, Industry
volunteers & Microsoft
28
WS1 & WS2
WS4
WS5 & WS6
Biomedical ConceptsFoundational Standards
![Page 29: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/29.jpg)
Automation of ADaM & TLF Generation using CDISC 360 enriched standards
Bhavin Busa (Vita Data Sciences), Prasanna Murugesan (AstraZeneca)CDISC 360: The Journey So Far and the Road Ahead April 28, 2020
![Page 30: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/30.jpg)
Agenda1. Current State: Analysis Datasets & TFL Execution2. CDISC 360 Enriched Metadata
CDISC 360 Enriched (Machine-readable) TFL Metadata
3. Future State with Concept-based Standards: Analysis Datasets & TFL Execution
4. Process Flow for CDISC 360 Proof of Concept (PoC) 5. TFL Automation Engine – PoC Design6. TFL Automation Engine – Live Demo7. Learnings so far 8. Next Steps
![Page 31: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/31.jpg)
Current State - without Concept-based Standards
![Page 32: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/32.jpg)
32
Current State - without Concept-based Standards: Analysis Datasets and TFL Generation
ADaM Specs* ADaM Programs*
ADaM Datasets+ ADaM Define+
TFL Specs* SAS Programs* TFL Outputs+ CSR
SAP & TLF Shells*
Submission of Datasets+
& CSRXPT files,
Define, ADRG, SAS
codes
Foundational Standards
Specify Build/Execute Report
* Manual Process+ Manual or Semi-automated Execution
![Page 33: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/33.jpg)
CDISC 360 Enriched Metadata
![Page 34: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/34.jpg)
CDISC 360: The Art of the Possible
34Reference: ‘CDISC 360 - The Journey so Far and the Road Ahead’, Peter Van Reusel, 28th April 2020
![Page 35: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/35.jpg)
Analysis Concept
Reference: ‘CDISC 360 - The Journey so Far and the Road Ahead’, Peter Van Reusel, 28th April 2020
![Page 36: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/36.jpg)
Analysis Result Concept
Reference: ‘CDISC 360 - The Journey so Far and the Road Ahead’, Peter Van Reusel, 28th April 2020
![Page 37: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/37.jpg)
CDISC ARM Metadata
37Reference: ‘Large-scale TFL Automation for regulated Pharmaceutical trials using CDISC ARM’, Stuart Malcolm, AD203, PharmaSUG 2019
Results
Display
Documents
Comments
WhereClausesWhereClauseIDs
![Page 38: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/38.jpg)
CDISC 360 Enriched (Machine-readable) TFL Metadata
![Page 39: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/39.jpg)
Additional TFL Metadata Required for Automation
39Reference: ‘Large-scale TFL Automation for regulated Pharmaceutical trials using CDISC ARM’, Stuart Malcolm, AD203, PharmaSUG 2019
Output
Style
Display Result
![Page 40: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/40.jpg)
CDISC 360 Enriched TFL Metadata Tables
Metadata View Table
Description Structure
Output The contents and format of each output (which displays, file format, etc.)
One record per Output per Display
Display List of all Displays - both generic library Display and study-specific (using in 1 or more Output)
One record per Display per Version
Result All result metadata required to describe the analysis and create display in output
One record per Result
WhereClause All the component parts of a where clause used to filter data
One record per where clause component
Style Stylesheet parameters associated with Outputs One record per Style per parameter
![Page 41: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/41.jpg)
CDISC 360 Enriched TFL Metadata Tables – Sample
![Page 42: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/42.jpg)
Future State - with Concept-based Standards
![Page 43: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/43.jpg)
Future State - with Concept-based Standards: Analysis Datasets and TFL Generation
ADaM Specs ADaM Programs
ADaM Datasets
ADaM Define + ARM
TFL Shells & Metadata
TFL Programs
TFL Outputs + ARM CSR
Submission of Datasets
& CSRXPT files,
Define, ADRG, SAS
codes
Analysis ConceptsAnalysis Result ConceptsFoundational Standards
Specify Build/Execute Report
TFL Designer* Design = Automated Process
* = Manual Process
SAP*
![Page 44: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/44.jpg)
Process Flow for CDISC 360 Proof of Concept (PoC)
![Page 45: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/45.jpg)
Process Flow for CDISC 360 PoC
SDTM to ADaM to TFL
Des
ign
Def
ine
Bui
ldE
xecu
te
Analysis ConceptsAnalysis Result ConceptsFoundational Standards
![Page 46: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/46.jpg)
TFL Automation Engine – Proof of Concept Design
![Page 47: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/47.jpg)
47
CDISC 360 – TFL Automation Engine PoC Design
Study Level ADaM
Data
CDISC 360 Enriched
ARM Metadata
R ShinySelect TFL of
Interest
Review data
Customize TFL Layout & Metadata
Select TFL Layout (Template)
SAS
Generate SAS Program and Define.xml*
Execute SAS Program
* ARM to be combined with ADaM Define
Validate and Deliver
Generate Output
![Page 48: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/48.jpg)
TFL Automation Engine – Live Demo!
![Page 49: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/49.jpg)
Learnings so far
![Page 50: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/50.jpg)
Machine-readable TFL Metadata• ARM + additional TFL Metadata
o Use case tested with enriched metadatao Can be consumed by any tool
• TFL Automation Engine PoCo Demonstrated execution of TFL & generation
of Define.xml + ARMo Organization can build an automation engine
their own way
• TFL Designero Will help build TFL Shells and ADaM Specs
• CDISC currently does not support TFL standards – can templates be developed?
50
WS1 & WS2
WS4
WS5 & WS6
Biomedical ConceptsAnalysis Concepts
Analysis Results ConceptsFoundational Standards
![Page 51: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/51.jpg)
Next Steps
Our plans for remaining part of PoC
![Page 52: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/52.jpg)
Next Steps in Automate Execution [CDASH SDTM ADaM TLFs]
• Collaborate with other workstreams to develop concept-based standards, ODM CRF, and Define-XML [per CDISC 360 defined scope]
• CDASH to SDTM• Test & finalize machine-readable metadata elements for mapping specifications• Autogenerate SDTM artifacts from CDASH via CDISC 360 Process Flow for PoC [DM, EX, LB, VS,
and trial design domains]
• SDTM to ADaM• Define, test & finalize machine-readable metadata elements for mapping specifications• Autogenerate ADaM artifacts from SDTM via CDISC 360 Process Flow for PoC [ADSL]
• ADaM to TFL• Adjust TFL metadata to meet CDISC ARM v1.0 for Define-XML v2.0 standards• TFL Designer – will be conceptualize but team to hold on further development of PoC
![Page 53: Automation of SDTM Generation & Artifacts using CDISC 360 … · 2020-07-08 · Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards Bhavin Busa (Vita Data](https://reader034.vdocuments.mx/reader034/viewer/2022042605/5f4fcbc426977e2ec6656fa0/html5/thumbnails/53.jpg)
Thank You!Bhavin Busa, Vita Data SciencesJianhui [Jimmy] Zhao, AllerganPrasanna Murugesan, AstraZeneca
Courtesy: Mahi Busa