1 - Data Model
Task: Establish a common data model for observational pharmacovigilance
OMOP proposes as one of its first tasks the development of a common data model to enable consistent application of analyses across multiple disparate data sources. This data model can include a standard representation of health care experiences (such as information related to drug utilization and condition occurrence), as well as common vocabularies for coding clinical concepts. In keeping with constraints of cost and time, the model will be aimed at supporting the analyses and the limited set of observational data sources. The model and any related tools will be made publicly available as early as feasible. The common data model should make use of existing standards such as National Drug Codes and ICD-9-CM classifications. The model will accommodate both administrative claims and EMR data. The model will build on prior work and will define several filetypes (enrollment/disenrollment, demographics, diagnoses, procedures, pharmacy dispensing, vital signs, laboratory data…). The common data model will fully specify each filetype, including data elements, file layout, definition of data elements, and format of data elements. (A detailed discussion of how this may be approached is contained in the section “Normalizing Non-specific Conditions” in Appendix B of the OMOP Design Proposal).
Data Model - A description of data that consists of all entities represented in a data structure or database and the relationships that exist among them. This will include a data dictionary and any mappings of vocabularies (ontology) that are required for normalizing the Research Core databases.
Deliverable: The Research Core (or an organization under contract to the Research Core) will produce a “data model” –i.e., a document specifying a standard framework for organizing observational data for identification analyses, and update it with findings from the implementation of the Research Core databases and analyses over time. OMOP will make the data model and any relevant code publicly available as early as feasible during the course of the pilot and will update it periodically.