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.

G

GDPR General Data Protection Regulation

The EU general data protection regulation (GDPR) is a privacy and security regulation applicable in the European Union and in the European Economic Area. 

This regulation updated and modernized the principles of the 1995 data protection directive. It was adopted in 2016 and entered into application on the 25th of May 2018.

The GDPR defines:

  • individuals’ fundamental rights in the digital age
  • the obligations of those processing data
  • methods for ensuring compliance
  • sanctions for those in breach of the rules

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