Glossary

Discover full dictionary

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510 K
A
Accountability
A
Accuracy
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Ad-Hoc Services
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Adequacy decision
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Adverse event
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Analysis data model (ADaM)
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Anonymization
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Appropriate safeguards
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Article 29 Working Party
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Artificial Intelligence
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Automated individual decision
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Auxiliary medicinal product
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Best-in-class drugs
B
Binding corporate rules (BCR)
B
Biometric data
B
Biotechnology
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Central Laboatory
C
Central imaging
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Chemistry, Manufacturing, and Controls (CMC)
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Term of the Day

Informed consent

Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.

R

Randomization and Trial Supply Management (RTSM )

The Randomization and Trial Supply Management (RTSM) is a software system that helps manage and automate the randomization of study participants to different treatment groups, as well as the supply and distribution of study drugs or other investigational products.

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