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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.

D

Data retention

Data retention refers to all obligations on the part of controllers to retain personal data for certain purposes. Some regulations and directives impose a certain data retention period.

The Data Retention Directive (Directive 2006/24/EC) contains an obligation for providers of electronic communications to retain traffic and location data of communications through telephone, e-mail, etc. The retention takes place for the purpose of the investigation, detection and prosecution of serious crime.

As for clinical trials, a data retention period of at least 25 years was fixed in article 58 of Regulation (EU) 536/2014.

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