1. Introduction, Future State, Process and Architecture of the PoC – Bhavin and Mikkel

2. PoC for Study Design and Configuration using CDISC 360 Concept-based Standards –Mikkel and Nicolas

3. Automation of SDTM & ADaM Generation and Artifacts using CDISC 360 Enriched Metadata –Bhavin and Jimmy

4. Automation of TFL Generation using CDISC 360 Enriched Metadata –Bhavin, Prasanna & Stuart

5. Concluding Remarks and Next Steps –Bhavin and Mikkel

6. Q & A session

10 mins

20 mins

20 mins

20 mins

5 mins

15 mins

Speaker: Bhavin

Automation of TFL Generation using CDISC

360 Enriched Metadata

Bhavin Busa (Vita Data Sciences), Prasanna Murugesan (AstraZeneca) & Stuart Malcolm (Frontier Science)

CDISC US Interchange 2020

Oct 7th, 2020

Agenda

1. Process Flow for CDISC 360 Proof of Concept (PoC)

2. CDISC 360 Enriched Metadata

❑ CDISC 360 Enriched (Machine-readable) TFL Metadata

3. TFL Automation Engine – PoC Design

4. TFL Automation Engine – Live Demo

5. Learnings from CDISC 360 PoC

Speaker: Bhavin

Speaker: Bhavin

CDISC 360: The Art of the Possible

5Reference: ‘CDISC 360 - The Journey so Far and the Road Ahead’, Peter Van Reusel, 28th April 2020

Speaker: Bhavin

Analysis Result Concept

Reference: ‘CDISC 360 - The Journey so Far and the Road Ahead’, Peter Van Reusel, 28th April 2020

Speaker: Bhavin

CDISC 360 Enriched (Machine-readable) TFL Metadata

Speaker: Bhavin

CDISC ARM v1 Metadata

DisplayDisplayOIDNameTitle

Document

ResultResultOID

DescriptionReason

PurposeDataset

WhereClauseAnalysisVariable

Documentation

ProgrammingCode

Speaker: Stuart

CDISC ARM v1 Metadata Extensions

DisplayResult

Output (Study, Analysis, Group, Filename/Type, Style)

Version

DisplayPatternGrouping

- AnalysisVar

- ByVarCodeReference

Parent

VersionGrouping:- Dataset

- WhereClause- AnalysisVar

- ByVarTemplateTitle 1..N

RowLabelHeaderHeader 1..N

Footer 1..N

Speaker: Stuart

CDISC 360 Enriched TFL Metadata (ARM++)

• Based on CDISC ARM v1

• Added OUTPUT & STYLE

• Extended DISPLAY and RESULT

• Parent

• Version

• Grouping and ByVar

• CodeReference

• Use-cases for production TFL automation

Speaker: Stuart

CDISC 360 Enriched TFL Metadata (ARM++): SampleSpeaker: Bhavin

TFL Automation Engine – Proof of Concept Design

13

CDISC 360 – TFL Automation Engine PoC Design

Study

Level ADaM

Data

CDISC 360

Enriched

TFL

Metadata

(ARM++)

R Shiny

Select 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

Speaker: Prasanna

TFL Automation Engine – Live Demo!

Speaker: Prasanna

Learnings from CDISC 360 PoC

Speaker: Bhavin

Machine-readable TFL Metadata

• ARM + additional TFL Metadata (ARM++)

o Use case tested with enriched metadata

o Can be consumed by any tool

o Review performed by CDISC ARM team

• TFL Automation Engine PoC

o Demonstrated execution of TFL & generation of Define.xml + ARM

o Organization can build an automation engine their own way

• TFL Designer

o Will help build TFL Shells and ADaM Specs

16

WS1 & WS2

WS4

WS5 & WS6

Biomedical ConceptsAnalysis Concepts

Analysis Results ConceptsFoundational Standards

Speaker: Bhavin

Thank You!Bhavin Busa, Vita Data Sciences

Prasanna Murugesan, AstraZeneca

Stuart Malcolm, Frontier Science

Courtesy: Mahi Busa