SHARE 2.0 and Other CDISC Innovation

2017 China InterchangeLauren Becnel, Ph.D.

CDISC VP, Strategy & Innovation21 September 2017

IT/Stats

External

MDRs

Clinical Research

Apps Clinical Care

Apps

Other

Systems

End

Users

SHARE &

Ecosystem

Tools

Versioned

CDISC

Standards Foundational Stds

Therapeutic Areas & Biomedical Concepts

Controlled Terms

Patients

Becnel, L. (2017). SHARE-ing CDISC Standards through a Cloud-BasedMetadata Repository. Appl Clin Trials.

Benefits of CDISC SHARE

3

System re-validation

planning, resourcing

Data-based decisions Change management

With or…

4

Without an MDR

Standards Components in CDISC SHARE

5

Classes, Domains and Variables

Controlled Terminologies

Examples RulesAssumptions

Norm. IG

Draft Domains/Variables in “Rolling Copy”

In SHARE MDR In SHARE Ecosystem

*Including Supplements such as Medical Devices & Pharmacogenomics/Genetics

Coming to SHARE MDR

Licensed Access for Members: CDISC SHARE Exports

6

https://www.cdisc.org/share/exports-user-documentation

Licensed Access for Member Subscribers: CDISC SHARE’s RESTful API

License includes access to:• Standards (e.g. SDTM 3.2, CDASH 1.1)

• Controlled Terminology packages (e.g. SDTM 2014-03-28)

• Package codelists

• Codelist (e.g. ACN)

• Classes

• Standard domains

• Class domains

• Class model variables

• Domain variables

• Variables

• Mappings

Lexical searching supported

7

https://www.cdisc.org/share/api-user-documentation

Visualizing CDISC Standards from the API

8

Trace-XML

Hume, S., Sarnikar, S., Becnel, L., Bennett, D. (2017). Visualizing and validating metadatatraceability within the CDISC standards. Proc AMIA Summit Clin Res Inf. AMIA, 2017:158-165.

9

New Features in CDISC SHARE 2.0

Adapted from Frederik Malfait, 20 April 2017 SHARE 2.0 Webinar

Linked, Versioned Standards Data

Rules Biomedical Concepts

Coming in 2018!

CDISC SHARE 2.0: A Global Content Repository

10Some content adapted from Johannes Ulander, SDTM, Graph databases and Biomedical Concepts, EU Interchange 2017 & Nuventra.com

XMLRDFJSON

Coming in 2018!

CDISC Data Transport & Sharing Standards

11

Study Design Model (SDM-XML) allows organizations to provide rigorous, machine-readable, interchangeable descriptions of the designs of their clinical studies, including treatment plans, eligibility and times and events.

Operational Data Model (ODM-XML) is a platform-independent format for exchanging and archiving clinical and translational research data, along with their associated metadata, administrative data, reference data, and audit information.

Dataset-XML supports the exchange of dataset data based on Define-XML metadata.

Define-XML provides the metadata for human and animal model datasets using the SDTM and/or SEND standards and analysis datasets using ADaM.

12

Clinical Trial Registry (CTR-XML)a single XML file that holds the information needed to generate submissions for clinical trial registry submissions primarily to the WHO, EMA EudraCT Registry and United States ClinicalTrials.gov.

Analysis Results Metadata (ARM) Define-XML extension that describes key analysis results and provides traceability back to ADaM.

Controlled Terminology (CT-XML) provides an ODM-based standard for publishing and exchanging the CDISC Controlled Terminology as provided by the NCI/EVS.

CDISC Data Transport & Sharing Standards

Bridging Research & Healthcare – HL7 FHIR, ODM2 & CDISC SHARE

13

Protocol

XML plus…

Coming in 2018!

Acknowledgements

CDISC SHARE Team• Anthony Chow

• Julie Chason

• Dr. Sam Hume

• Darcy Wold

• Ann White (Communications)

14

TransCelerateBiopharma, Inc.• Brooke Hinkson

SHARE/TCB

• Frederik Malfait