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.

P

Purpose limitation

Purpose limitation is a fair information practices principle, part of the original OECD Guidelines, and a piece of many privacy and data protection regulations such as the GDPR. 

The purposes for which personal data are collected should be specified no later than at the time of data collection and the subsequent use of that personal data is limited to the fulfillment of those purposes or such others as are not incompatible with those purposes and as are specified to the individual on each occasion of change of purpose, or for which there is a further legal basis that would not require notification.

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