Concept modeling focuses on what is happening in the clinical setting. Once the clinical context is understood, focus shifts to data and metadata needed to represent the concept/process for building the information requirements. Concept mapping has two development pathways: new and existing concepts. While concept modeling is not required for foundational team projects, their use is strongly encouraged when teams are developing new concepts to promote increased understanding and more cohesive modeling.
One way to view this process is with a series of steps that precisely define and constrain the scope. Looking at the image below, once the core set of concepts is developed, determine which concepts are and are not addressed in current standards. Any concepts that have not been addressed in current CDISC standards must be sufficiently defined by the Concept Developers to reach a common understanding with the Clinical Expert. Concept maps and examples are tools that facilitate this process. See Appendix B for more information.
Triage of Core Clinical Concepts
C-MAP is the software used to create concept maps and be can be freely downloaded here.
Concept Modeling Training
Metadata Developers new to concept modeling are encouraged to review the “Development of Concepts and Concept Metadata” document referenced below and listen to the recorded training at the start of this stage. It is also recommended that new Metadata Developers attend the weekly Concept Modeling Forums organized by the Concept Modeling Expert. The Concept Modeling Forum provides an opportunity for cross-project review of modeling approaches to minimize inconsistencies.
- Training Module: Development of Concepts and Concept Metadata
- Recorded Training
- Concept Modeling Forum