Table 2.

Implementation of EMA guidelines on patient registries.

Data element	Data items	ARCA registry
Administrative information	Name of center	✓
	Availability of informed consent	✓
	Registry entry date	✓
	Registry exit date and circumstances	✓
	Dates of encounters	✓
Patient data	Age or birthdate	✓
	Gender	✓
	Lifestyle factors (alcohol, smoking, employment)	✓
Disease characteristics	Diagnosis	✓
	Date of clinical diagnosis or first consultation	✓
	Genomic information	✓
	Severity/stage	✓
	Milestones/outcomes/functional status	✓
Comorbidities	Relevant comorbidities (past/current)	✓
Disease-related and relevant concomitant treatments	Substance	✓
	Dose	✓
	Start date	(✓) *
	End date	(✓) *
	Route	✓
	Schedule	×
	Brand name	×
Pregnancy	Pregnancy status/outcome	×
PROMs	Patient-reported outcomes in clinical practice	• **
Safety reporting	adverse events/reactions	• ***

EMA, European Medicines Agency.

^*Indirect assessment by longitudinal capture of current treatment;

^**planned;

^***once closer to monitoring of drug treatments.