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510 K
A
Accountability
A
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Ad-Hoc Services
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Adequacy decision
A
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Analysis data model (ADaM)
A
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A
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A
Article 29 Working Party
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A
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A
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B
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Biotechnology
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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.

P

Personal data breach

Personal data breach means a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed.