The purpose of creating a concept map is to understand data about a topic. They are less likely to be needed for “familiar’ data, the kind most people would understand from their own experience as a patient (instructions on using the term “patient” vs. “subject” are in the TAUG Template). Sometimes the process that gives rise to data is unfamiliar, and it helps to draw a concept map that illustrates the process. This can be particularly helpful when the process is complex and the data describes parts of the process which are somewhat distant from the main focus (e.g., the event, intervention, or test/result). It may be helpful to draw a concept map at a more detailed level, closer to the level of an SDTM observation, to identify the relationships among data items. For example, whether a particular data item is part of an observation of an observation result or whether there is a single observation or series of observations based on the results of previous observations. If concept maps in other TA User Guides can be referenced or re-used, a new concept map is not necessary. Below is a concept map illustrating the process for creating concept maps.
New and different research concepts are evaluated with the assistance of the Clinical Expert to ensure the data are clearly understood. Concept maps illustrating relationships among the data are developed to facilitate this process. Concept maps are diagrams that include “bubbles” representing concepts/ideas/things and labeled arrows that represent the relationships between the concepts/ideas/things. The diagrams use color coding, illustrated below, to classify concepts. This classification is based on classes in the Biomedical Research Integrated Domain Group (BRIDG) model. These color/symbol pairs are used to highlight common elements that occur in clinical data and, therefore, give rise to common patterns of data. Some concepts are not coded; they have a thinner, black outline, and no accompanying symbol. These may include the subject of an observation as well as characteristics, or attributes, of the coded concepts. The goal of concept mapping is to develop a series of stock concept maps that can be re-used.
Figure 5: Concept Classification Key for Concept Maps
The SDTM Expert works with the Project Team to address areas not covered by the current SDTMIG. It is crucial that the SDTM Expert is included in this process and works closely with the SDS team. Any issues that cannot be resolved for the first version of the standard must be placed on the SDS issues list so that resolution can be addressed in a later version.
Figure 6: Example Concept Map
Scoping Review
At the conclusion of the Scoping Stage, a meeting will be scheduled with the appropriate experts to check that the modeling approach is consistent and agreeable.