Conducting requirements analyses for research using routinely collected health data: a model driven approach.

Background: Medical research increasingly requires the linkage of data from different sources. Conducting a requirements analysis for a new application is an established part of software engineering, but rarely reported in the biomedical literature; and no generic approaches have been published as to how to link heterogeneous health data.

Methods: Literature review, followed by a consensus process to define how requirements for research, using, multiple data sources might be modeled.

Results: We have developed a requirements analysis: i-ScheDULEs - The first components of the modeling process are indexing and create a rich picture of the research study. Secondly, we developed a series of reference models of progressive complexity: Data flow diagrams (DFD) to define data requirements; unified modeling language (UML) use case diagrams to capture study specific and governance requirements; and finally, business process models, using business process modeling notation (BPMN).

Discussion: These requirements and their associated models should become part of research study protocols.