1. 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

2. 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

3. Representing CDISC Standards in RDF

4. 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

5. Deliverables

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

7. SDTM Walk-Through

13. 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

14. GitHub Repository

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

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

17. 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 Pipeline

18. Representing Conformance Checks in RDF Backup Slides

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

20. 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 Rationale

21. 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 Deliverables

22. Protocol Representation in RDF

23. Tasks Represent Schedule of Assessments in RDF Represent Trial Design in RDF Represent the PRM in RDF

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

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

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

27. PhUSE Conference Brussels

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