Glossary

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510 K
A
Accountability
A
Accuracy
A
Ad-Hoc Services
A
Adequacy decision
A
Adverse event
A
Analysis data model (ADaM)
A
Anonymization
A
Appropriate safeguards
A
Article 29 Working Party
A
Artificial Intelligence
A
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.

C

Clinical Trial Site

A clinical trial site (or clinical site) refers to a physical location, such as a hospital, research center, or medical facility, where the clinical trial activities are conducted. It is the place where participants are recruited, enrolled, and receive the investigational treatment or intervention, as well as where data collection, monitoring, and other trial-related procedures take place. Clinical trial sites play a crucial role in ensuring the proper conduct of the trial, adhering to the protocol, and maintaining participant safety and data integrity.

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