speaker: bhavin
TRANSCRIPT
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
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 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
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
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