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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

Special categories of personal data

Special categories of personal data include data that reveals "racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade-union membership, genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural's sex life or sexual orientation" (Article 10 of Regulation (EU) 2018/1725; Article 9 of the GDPR). This data is also referred to as sensitive data.

The processing of such information is in principle prohibited, except in specific circumstances. It is possible to process sensitive data for instance if the processing is necessary for the purpose of medical diagnosis, or with specific safeguards in the field of employment law, or with explicit consent of the data subject.