Glossary

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510 K
A
Accountability
A
Accuracy
A
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
A
Artificial Intelligence
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Automated individual decision
A
Auxiliary medicinal product
B
Best-in-class drugs
B
Binding corporate rules (BCR)
B
Biometric data
B
Biotechnology
C
Central Laboatory
C
Central imaging
C
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.

I

Interactive Web Response System (IWRS)

It is an online software tool used in clinical trials to manage patient randomization, drug supply, and trial site communication. The system allows study personnel to log into a secure website and manage trial-related activities in real-time. IWRS is a type of IRT that specifically uses web-based technology.

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