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.

T

Third country

A third country, in the sense of the GDPR, is a country which is not bound by the GDPR - as opposed to the 28 Member States of the EU and the three European Economic Area (EEA) countries Norway, Liechtenstein and Iceland.

Third countries may be recognised through an adequacy decision as offering an adequate level of protection for personal data in order to enable transfers of personal data from the EU and EEA Member States to them.

The effect of such a decision is that personal data can flow from the EU and EEA Member States to that third country (within the limit of the material scope as described by each Decision) without any further requirements.

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