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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 monitoring committee (DMC)

The Data Monitoring Committee (DMC) is an independent committee of experts established to monitor the safety and efficacy of a clinical trial while it is in progress.The primary role of a DMC is to review clinical trial data on a regular basis to ensure that the trial is being conducted in accordance with the protocol, and to evaluate the safety and efficacy of the investigational product. The DMC also provides recommendations to the study sponsor and/or steering committee regarding the continuation, modification, or termination of the trial based on their review of the data.The DMC typically consists of clinical experts, statisticians, and other relevant specialists who are independent of the study sponsor and have no financial or other conflicts of interest related to the study.

The DMC is established prior to the start of the trial and operates independently of the study sponsor and investigators.The establishment of a DMC is important for ensuring the safety and welfare of clinical trial participants, as well as for maintaining the scientific integrity of the study. By providing an independent review of the trial data, the DMC can help to ensure that the study is conducted in a manner that is safe, ethical, and scientifically sound.