Emerging Technologies

Semantic Web and Data Integration This meeting will start at 5 min past the hour As a reminder, please place your phone on mute unless you are speaking 18 Oct 2013

Meeting Agenda • • • • • Representing CDISC Standards in RDF - Update Team CDISC Conformance Checks in RDF – Update Team Protocol Representation in RDF – Update PhUSE Conference Brussels AOB

Representing CDISC Standards in RDF

Representing CDISC Standards in RDF • • • • • •

Deliverables:

CDASH v1.1 including domain assumptions SDTM v1.2/SDTM v3.1.2 including domain assumptions SDTM v1.3/SDTM v3.1.3 including domain assumptions SEND IG v3.0 including domain assumptions ADaM v2.1/ADaM IG v1.0

Integrate with Controlled Terminology

Deliverables

Schema Structure Meta-Model Schema Controlled Terminology Schema CDISC Schema CDASH Schema SDTM Schema CDASH SDTM SEND Schema ADaM Schema SEND ADaM

SDTM Walk-Through

SDTM Walk-Through

SDTM Walk-Through

SDTM Walk-Through

SDTM Walk-Through

SDTM Walk-Through

Finishing Line • • • • • • Update a few remaining namespaces for consistency Final check of the CDISC schema Final check of the domain assumptions Consistent formatting of the import files Dirty work – typo’s, trailing blanks, non-ASCII characters etc.

Code repository – github.com/phuse-org/rdf.cdisc.org

GitHub Repository

Next Steps • • • • Call for review of draft models Discuss ownership process with CDISC Discuss SHARE export facility to RDF Alignment and final edit

New Teams Starting… • • Representing CDISC Conformance Checks in RDF – Scott Bahlavooni and Josephine Gough Protocol Representation in RDF – Geoff Low and Frederik Malfait

Pipeline • • • • Representing and Accessing Clinical Trial Data in RDF – Tentative: Phil Ashworth and Marc Andersen Data Analysis and Reporting Model – To be explored Representing Regulations and Guidance in RDF – Status to be discussed EHR Enabled Research – To be explored

Representing Conformance Checks in RDF Backup Slides

Objective • • Represent SDTM and ADaM validation rules in RDF Implementation algorithms will not be represented

Rationale • • • ADaM standard includes validation rules Identifying all validation rules associated with an SDTM (ADaM) domain or variable is a non-trivial, manual task Vendor-agnostic representation of SDTM validation rules

Deliverables • • • Define an ontology for validation rules Identify version(s) of SDTM/ADaM validation rules for representation Link the RDF representations to CDISC standards represented in RDF

Protocol Representation in RDF

Tasks • • • Represent Schedule of Assessments in RDF Represent Trial Design in RDF Represent the PRM in RDF

Challenges • • PRM primarily BRIDG based, unlike CDASH/SDTM End of Year, deadlines

Approach • • • Read and understand – Study Design Model (XML) – Protocol Representation Model (PRM) Identify key components – Classes – Properties Model using XLSX and TopBraid

Approach (cont.) • • • Consultation – Dave Gemzik (head of PRG) Expectations – ~ 1hr + 1hr Communication – PhUSE Wiki – – Email Team meetings

PhUSE Conference Brussels

What happened • • • More people talking about RDF and Linked Data Presentation Semantic Technology and CDISC Standards PhUSE CSS Discussion Club