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 23 Aug 2013

2. Emerging Technologies Semantic Web and Data Integration 23 Aug 2013

3. Meeting Agenda Representing CDISC Standards in RDF Update New Use Cases Overview Group I Use Cases Group II Use Cases Next Steps

4. Representing CDISC Standards in RDF Phase I 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 Controlled Terminology for CDASH, SEND, and ADaM

5. Representing CDISC Standards in RDF Phase I Status: NCI assumed ownership of Controlled Terminology RDFs Draft RDFs of CDISC models/IGs completed by three sub-teams Phase I completed

6. Representing CDISC Standards in RDF Phase II: Restructure three model-based sub-teams into one Consolidate draft models into a final work package Configure GitHub code repository Publish consolidated, draft models on GitHub for public review Discuss and finalize review and ownership process with CDISC

7. Group I (Sep 2013): Representing Regulations and Guidance in RDF – Mitra Representing CDISC Conformance Checks – Scott Representing SDTM and ADaM Datasets in RDF – Phil Toolsets to Access Clinical Trial Data Represented in RDF (e.g. SAS, R, etc.) – TBD New Use Cases: Overview

8. Group II (Oct/Nov 2013): Representing CDISC Protocol Representation Model in RDF – TBD EHR Enabled Research – TBD New Use Cases: Overview

9. Objective: Evaluate the feasibility of representing regulations and guidance documents in RDF Rationale: Various sources (e.g. CDISC standards) refer to regulations and guidance documents. Representing the regulations and guidance documents in RDF enables the linking of said documents to RDF sources Representing Regulations and Guidance Documents in RDF

10. Deliverables: Identify regulations and guidance documents referenced in CDISC standards Evaluate the feasibility of representing regulations and guidance documents in RDF. If feasible, represent the regulations and guidance documents in RDF If feasible, link the RDF representations to CDISC standards represented in RDF Representing Regulations and Guidance Documents in RDF

11. 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 a SDTM (ADaM) domain or variable is a non-trivial, manual task Vendor-agnostic representation of SDTM validation rules Representing SDTM and ADaM Validation Rules in RDF

12. Deliverables: Define ontology for validation rules Identify version(s) of SDTM/ADaM validation rules for representation Represent SDTM/ADaM validation rules in RDF Link the RDF representations to CDISC standards represented in RDF Representing SDTM and ADaM Validation Rules in RDF

13. Objective: Represent SDTM and ADaM clinical trial data in RDF Rationale: Representing clinical trial data in RDF enables more efficient data integration Deliverables: RDF representation of publically available SDTM and ADaM datasets ??? A white paper discussing the steps needed to put clinical trial data in RDF/benefits of data in RDF? Representing SDTM and ADaM Datasets in RDF

14. Objective: Identify toolsets to access and analyze clinical trial data represented in RDF Rationale: Realizing the benefits of clinical trial data represented in RDF requires toolsets that can access and analyze the data Toolsets to Access and Analyze Clinical Trial Data Represented in RDF

15. Deliverables: Document toolsets including methods for accessing and processing RDF data sources ??? White paper, code repository, ?? Toolsets to Access and Analyze Clinical Trial Data Represented in RDF

16. Representing CDISC Protocol Representation Model (PRM) in RDF EHR Enabled Research – IHE and CDISC developed an integration profile provide that allows for the retrieval of metadata from an ISO 11179 metadata repository. The profile can be used to retrieve data from an EHR export document using a metadata enriched eCRF Group II Use Cases

17. Creation of sub-teams – Contact the sub-team leads or indicate your interest on the PhUSE Wiki Sub-team kick-off meetings: 09Sep – 13Sep Group I Use Cases: Next Steps