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 Dianes 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)
Slide 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
Slide 4
CDISC 2014 SHARE TA RC Pilot 4 TO Concept Map How to get from
Here Semantics Manager Here
Slide 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
Slide 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
Slide 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
Slide 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
Slide 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
Slide 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
Slide 11
CDISC 2014 11 ISO 11179 Concept System added to the SHARE
Metamodel Concept Layer
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
Slide 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