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.

F

Fairness and Transparency

Fairness and Transparency mean that data subjects must be aware of the fact that their personal data will be processed, including how the data will be collected, kept and used, to allow them to make an informed decision about whether they agree with such processing and to enable them to exercise their data protection rights. Consent notices should not contain unfair terms and supervisory authority powers should similarly be exercised fairly.

Fairness and transparency are two of three requirements established by the General Data Protection Regulation for the processing of personal data. Personal data shall be processed lawfully, fairly and in a transparent manner in relation to the data subject. These three requirements are part of the data protection principles.

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