ABSTRACT

The goal of this chapter is to help an investigator plan an EHR-based research project. The chapter begins by introducing the research process. These steps include formulating the research question, ensuring EHR data are available and accessible, protecting data privacy, security, and human subjects’ participation, and identifying the key stakeholders and research sponsors. EHR research that begins with a clear and concise research question logically connects to the data requirements. Research data may entirely come from a single EHR, multiple EHRs, or supplemented via additional data collection, whether primary or secondary. Data privacy and security, as well as ethics board approval, are discussed in a separate section, underscoring their importance. In many cases, secondary research from the EHR will be exempt from institutional review board review, streamlining the process. The chapter also includes an EHR research planner that can be used as an aid to record the many pertinent details of a given research project.