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Automation of TFL Generation Using CDISC 360 Enriched Metadata

Automation processes for TFL Generation

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Diya
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38 views17 pages

Automation of TFL Generation Using CDISC 360 Enriched Metadata

Automation processes for TFL Generation

Uploaded by

Diya
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Speaker: Bhavin

1. Introduction, Future State, Process and 10 mins


Architecture of the PoC – Bhavin and Mikkel
2. PoC for Study Design and Configuration using 20 mins
CDISC 360 Concept-based Standards –
Mikkel and Nicolas
3. Automation of SDTM & ADaM Generation and
20 mins
Artifacts using CDISC 360 Enriched Metadata –
Bhavin and Jimmy
4. Automation of TFL Generation using CDISC 20 mins
360 Enriched Metadata –
Bhavin, Prasanna & Stuart
5. Concluding Remarks and Next Steps – 5 mins
Bhavin and Mikkel
6. Q & A session 15 mins
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
Speaker: Bhavin

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

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

Analysis Result Concept

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

CDISC 360 Enriched (Machine-readable) TFL Metadata


Speaker: Stuart

CDISC ARM v1 Metadata

Display
DisplayOID
Result Name
ResultOID Title
Description Document
Reason
Purpose
Dataset
WhereClause
AnalysisVariable
Documentation
ProgrammingCode
Speaker: Stuart

CDISC ARM v1 Metadata Extensions


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

Display
Result Parent
Version Version
DisplayPattern Grouping:
Grouping - Dataset
- AnalysisVar - WhereClause
- ByVar - AnalysisVar
CodeReference - ByVar
Template
Title 1..N
RowLabelHeader
Header 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: Bhavin

CDISC 360 Enriched TFL Metadata (ARM ++): Sample


TFL Automation Engine – Proof of Concept Design
Speaker: Prasanna

CDISC 360 – TFL Automation Engine PoC Design

R Shiny SAS
CDISC 360
Enriched
Select TFL of
TFL Generate SAS
Metadata Interest Execute SAS
Program and
(ARM++) Program
Define.xml*
Select TFL Layout
(Template)
Customize TFL Generate Output
Layout & Metadata
Study
Level ADaM Review data Validate and Deliver
Data

* ARM to be combined with ADaM Define


13
Speaker: Prasanna

TFL Automation Engine – Live Demo!


Speaker: Bhavin

Learnings from CDISC 360 PoC


Speaker: Bhavin

Machine-readable TFL Metadata


• ARM + additional TFL Metadata (ARM++)
o Use case tested with enriched metadata
WS1 & Biomedical Concepts
o Can be consumed by any tool WS2 Analysis Concepts
Analysis Results Concepts
Foundational Standards
o Review performed by CDISC ARM team

• TFL Automation Engine PoC WS4


o Demonstrated execution of TFL & generation of
Define.xml + ARM
o Organization can build an automation engine their WS5 &
own way WS6

• TFL Designer
o Will help build TFL Shells and ADaM Specs

16
Thank You!
Bhavin Busa, Vita Data Sciences
Prasanna Murugesan, AstraZeneca
Stuart Malcolm, Frontier Science

Courtesy: Mahi Busa

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