CDISC 2020 US InterchangeA Virtual Event | 7-8 October 2020

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 and 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

Workstream 4 & 6 - Task Team Leads

SDTM/ADaM Automation

Bhavin Busa, Vita Data Sciences

TFL Automation

Jianhui (Jimmy) Zhao, AbbVie

Prasanna Murugesan, AstraZeneca

Stuart Malcolm, Frontier Science

Workstream 6 LeadWorkstream 4 Lead

Mikkel Traun, Novo Nordisk

App Development Lead System Architect

Nicolas De Saint Jorre, XClinical

Tobias Krøgholt, Novo Nordisk

Speaker: Mikkel & Bhavin

CDISC 360 Industry Perspective

SponsorStudyMDR

Enhance Standards

Concept Based

Publish Standards

CDISC Library

DefineUse Case 1

BuildUse Case 2

ExecuteUse Case 3

Indu

stry

CDISC 360 Use Cases 1, 2 and 3 Speaker: Mikkel & Bhavin

CDISC 360 Enriched Metadata

Speaker: Bhavin

Machine-readable CDISC 360 Enriched Metadata

Structural Conceptual

SemanticProcess

Speaker: Bhavin

Future State with Concept-based Standards

Speaker: Bhavin

Future State - with Concept-based Standards:Study Specification in a CDISC 360 Study Builder App

DefineStudy

DesignStudy

SelectConcept Based

StandardsBuildStudy

SpecificationSpecify:- Identifiers- Title- Standard Versions

Specify- Study Arms- Epochs- Elements- Interventions

Select & Configure:- Objectives- Endpoints- Activities- Assessments

Generate:- Protocol Content- Standards Plan- ODM-XML + CRF- Define-XML

ProtocolOutline

Study Specification

SponsorStudyMDR

Industry StandardsSponsor StandardsStudy Definitions

Speaker: Mikkel

11

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

= Automated Process

Study Specification

SponsorStudyMDR

Industry StandardsSponsor StandardsStudy Definitions

Speaker: Bhavin

SAP & TFL Shells*

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

Specify Build/Execute Report

TFL Designer* Design = Automated Process

SponsorStudyMDR

Industry StandardsSponsor StandardsStudy Definitions

Speaker: Bhavin

Flowchart and Architecture for PoCHow the Study Metadata fit in the overall CDISC 360 vision

Speaker: Bhavin

Design

Define

Build

Execute

Speaker: Mikkel

Challenging the Status Quo

"copy-paste programming” to "meta-programming"

15

Speaker: Bhavin