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510 K
A
Accountability
A
Accuracy
A
Ad-Hoc Services
A
Adequacy decision
A
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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
Auxiliary medicinal product
B
Best-in-class drugs
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

Cookies

Cookies are short text files stored on the user’s device by a web site.  Cookies are normally used to provide a more personalised experience and to remember user profile without the need of a specific login. Also it can be placed by third parties (such as an advertising network) in end users´ devices and maybe be used to track users when surfing across different websites associated to that third party.