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510 K
A
Accountability
A
Accuracy
A
Ad-Hoc Services
A
Adequacy decision
A
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A
Analysis data model (ADaM)
A
Anonymization
A
Appropriate safeguards
A
Article 29 Working Party
A
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A
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A
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B
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B
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B
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B
Biotechnology
C
Central Laboatory
C
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C
Chemistry, Manufacturing, and Controls (CMC)
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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.

C

Controller

A controller is a person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data.