1. © CDISC 2014 1 SHARE TA Research Concepts Pilot

2. © CDISC 2014 SHARE TA RC Pilot SHARE TA RC Pilot: Bringing together the TA Project RC experience with the SHARE Approach to RCs to streamline and simplify the TA development process 2 CFAST TA Development Process Concept Maps and components SHARE Metadata display tables for 2 Tas Diane’s updated Metadata display tables. ISO 11179-based SHARE Metamodel NCI Concepts already in SHARE as building blocks for RCs Additional Information Science / Business Analysis Best Practices Research Concepts from other sources (Roche, Lilly) TA Project Experience with RCs SHARE Approach to RCs SHARE TA RC Pilot Top Down (from Concept Maps) Bottom Up (from Existing Standards)

3. © CDISC 2014 Current SHARE Thinking on RCs 3 Semantics Manager provides the place to house the RCs, but not the mechanism to develop RCs (Semantics Manager can do it, but its not really built for RC development). This pilot will aim for RC alignment with BRIDG rather than creating RCs starting with BRIDG (using a BRIDG-instantiated tool) since we already have experience with the BRIDG-instantiated approach (and we have candidate solutions that would work, e.g. ADL Workbench). This pilot will give us more knowledge about how SHARE will source and use RCs and what they look like in Semantics Manager

4. © CDISC 2014 SHARE TA RC Pilot 4 TO Concept Map How to get from Here Semantics Manager Here

5. © CDISC 2014 SHARE Research Concept Principles Meets the needs of the CDISC community first Research Concepts are standards Research Concepts exist in the SHARE Semantic Layer ISO 11179 based meta-model RCs can be represented independent of implementation Structure, not content focused Requirements driven approach / Test Driven Development 5

6. © CDISC 2014 SHARE Research Concept Principles RCs applied by Metadata Developers using a Methodology Feasibility matters Opportunistic support for healthcare interoperability CDISC standards model focused – filling gaps BRIDG alignment, not BRIDG instantiation One SHARE vocabulary (create a wiki page) 6

7. © CDISC 2014 What are RCs? Working Definition ISO 11179 Definition: A Concept is a unit of knowledge created by a unique combination of characteristics.  In general, for CDISC: Research Concepts are high-level building blocks of clinical research information that encapsulate lower level implementation details like variables and terminologies.  For SHARE: A research concept is a unique combination of SHARE Concepts and Rules that define the independent units of knowledge found within each CDISC class. 7

8. © CDISC 2014 Research Concepts are Hard to Define Wiki page: Definitions for Research Concepts  A quick review turned up about 15 proposed definitions Many attempts to define RCs include descriptions of a solution  Disparity in opinions on how RCs should be created is reflected in the definitions The breadth of RC scope has made a simple definition difficult  IMO, the lack of complete CDISC standards model, including the Conceptual Layer, confounds the ability to define RCs  RCs represent multiple parts of the CDISC model 8

9. © CDISC 2014 1. Support TA Standards Development Support the TA projects in developing concept-based standards for all new projects by early 2015  Faster, more effective way to develop TA standards  Development of standards that are consistent with the CDISC Model Enable SMEs to work with conceptual representations of the standards represented using natural language  Communicate without using the structural metadata (e.g. SDTM domain structures and variables) Support C-Map templates  Provide re-usable concepts as C-Map templates 9

10. © CDISC 2014 2. Support TA Standards Development Provide a methodology for transforming conceptual models into structural models  Process for converting conceptual models to structural models that represent standards like CDASH and SDTM  Include a process for verifying the conceptual models Represent clinical phenomena using a combination of Concepts and associated Rules  Using ISO 11179 10

11. © CDISC 2014 11 ISO 11179 Concept System added to the SHARE Metamodel Concept Layer

12. © CDISC 2014 SHARE Metamodel Conceptual Layer using Asthma TAUG Metadata Display Worksheet 12 Allergen Skin TestWheal Diameter Allergen Skin Test Wheal Diameter

13. © CDISC 2014 The CDISC Model - Current 13

14. © CDISC 2014 TA Development Process 14

15. © CDISC 2014 RC Concept Spreadsheet 15 Wayne mentioned on 10/15/2014 Metadata Tools TC:  There may be many RC spreadsheets, but we need to have one that is completely human-readable.  The spreadsheet should have, at mininum: RC Name, in SME language RC Definition RC CUI/C-Code/UUID

16. © CDISC 2014 TAs to Pilot Labs for dyslipidemia Questionnaires for Schizophrenia Discussion:  Where are these projects in the process, e.g., do we have concept maps? 16