These spreadsheets are an interim mechanism for defining research concept metadata. Developing concepts under this approach starts with a workbook[1] that contains two standard introductory sheets and a “template” that includes a set of “concept variables” appropriate for the kind of data being developed. The second introductory sheet explains the layout of the template, which includes:
- Concept level metadata at the top of the sheet (e.g., Definition, SDTM TEST/TESTCD, Domain)
- Rows for each concept variable with columns for associated CT and SDTM variables
- A place to describe associations with other concepts at the bottom of the sheet
The Concept Developer copies the template sheet to a new sheet, fills in the concept-level metadata, deletes any concept variable rows that are not relevant for the concept, populates or modifies Controlled Terminology and SDTM variable information as needed, and adds relevant information about associations with other concepts.
Making a decision about whether a concept variable is relevant for a particular concept can often be made on the basis of the SDTM variable(s) associated with it. In some cases, a deeper understanding of the concept variables is needed, and in these cases, the Concept Developer may need to refer to the BRIDG model, to look up the definitions of BRIDG classes and attributes, or to the ISO 21090 data type standard, to understand the complex data types associated with a concept variable. Please see Appendix B for more details on the process for developing metadata and creating concept maps, including an example from the TA User Guide-Asthma, Metadata, Pulmonary Function Tests, p. 6.
For those who wish to refer to the BRIDG model, it may be downloaded from the BRIDG website. Choose “Download Model” from the options across the top of the page. To view the model, you will need software called EA Lite. This is the free viewer for Enterprise Architect, the software in which the model is maintained. This software can be downloaded from Sparx Systems page.
The BRIDG website features FAQs you may find helpful. The BRIDG Model download includes additional helpful materials, particularly the BRIDG User’s Guide in the Documentation folder. Section 6.6 of this document is a “UML Primer”, which explains the basics of the boxes and lines you’ll see when you browse the model.
[1] A precursor to concept development is creation of the necessary workbook. Some workbooks have already been created, but additional workbooks may be needed for a particular project. Workbooks are developed by the Modeling Expert (Diane Wold).