Table 1.

Type of structured data in RWD sources possibly needed to define elements of research question, depending on research question

What is the research question?
In specifying the research question, include the relevant data elements13 such as population, intervention and comparator (treatments), and outcome, as applicable (eg, to assess effects of intervention compared with comparator treatment on the incidence of outcome over 2 years (timing) in a population of patients with disease).
For Research Involving This Data Element:	Type of Structured Data in RWD Sources Possibly Needed to Define Data Elements*
Population	Diagnosis codes Procedure codes Laboratory values Pharmacy data (rarely)
Intervention and comparator (treatments; drug, biologic, or medical device)	Pharmacy data Procedure codes
Outcome	Diagnosis codes Procedure codes Laboratory values

Abbreviation: RWD, real‐world data.

^* Specific type of data for each research data element depends on the research question