Glossary

Discover full dictionary

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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

Central imaging

In a clinical trial, central imaging refers to the evaluation and interpretation of medical imaging data by a central review facility rather than the local site investigator. This central review facility typically consists of a team of trained radiologists or imaging experts who are responsible for assessing and analyzing imaging data from all participants in the clinical trial.Central imaging is often used in clinical trials to ensure that imaging data is analyzed in a consistent and standardized manner, minimizing potential biases that may arise from local site variability in imaging interpretation. This can improve the accuracy and reliability of imaging data in clinical trials, leading to more meaningful

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