Table 1.

Electronic health records in research

Type	Example	Status
Observational studies	Health utilization Drug utilization Epidemiology (incidence/prevalence) Natural history Risk factors	Widely used and accepted
Safety surveillance	Traditional post-marketing safety surveillance	Widely used and accepted
	Active surveillance (e.g., Sentinela)	Emerging
Clinical research	Hypothesis generation	Accepted
	Feasibility assessments	Accepted
	Performance improvement, guideline adherence	Accepted
	Patient recruitment	Emerging
	Comparative effectiveness, health technology assessments	Emerging
	Pragmatic trials (e.g. PROBE design)	Emerging
	Point of care randomization	Emerging
	Registry randomized trials to test new interventions	Emerging
	Source data to populate eCRF (eliminating or minimizing need for data extraction/data entry)	Emerging/potential
	Endpoint or SAE ascertainment	Emerging/potential
Regulatory	Safety surveillance, pharmacovigilance	Accepted
	New indications or marketing authorization	Potential

^aSentinel is the United States Food and Drug Administration’s national electronic system to proactively monitor medical product safety post-marketing, through rapidly and securely accessing data from large amounts of electronic healthcare records, insurance claims, and registries, from a diverse group of data partners [24]

PROBE prospective randomized open blinded endpoint, eCRF electronic case report form, SAE serious adverse event