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L
Legal basis for processing
L
Legally designated representative
L
Limited storage periods
L
Local Site Investigator
N
Natural History Study
O
Observational Study
O
Observer-reported outcome (ObsRO)
O
Orphan Drug Designation (ODD)
P
Patient-reported outcome (PRO)
P
Performance outcome (PerfO)
P
Personal data
P
Personal data breach
P
Pharmacokinetics (PK)
Population Pharmacokinetics
P
Population pharmacokinetics (pop PK)
P
Principal investigator
P
Principles of data protection
P
Privacy
P
Privacy Enhancing Technologies (PETs)
P
Privacy Enhancing Technologies (PETs)
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Term of the Day

Natural History Study

A natural history study is a preplanned intended to track the course of the disease. Its purpose is to identify demographic, genetic, environmental, and other variables (e.g., treatment modalities, concomitant medications) that correlate with the disease’s development and outcomes. Natural history studies are likely to include patients receiving the current standard of care and/or emergent care, which may alter some manifestations of the disease.

S

Serious adverse event

Serious adverse event means any untoward medical occurrence that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, is life-threatening, or results in death.