Glossary

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510 K
A
Accountability
A
Accuracy
A
Ad-Hoc Services
A
Adequacy decision
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Adverse event
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Analysis data model (ADaM)
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Anonymization
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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.

D

Data retention

Data retention refers to all obligations on the part of controllers to retain personal data for certain purposes. Some regulations and directives impose a certain data retention period.

The Data Retention Directive (Directive 2006/24/EC) contains an obligation for providers of electronic communications to retain traffic and location data of communications through telephone, e-mail, etc. The retention takes place for the purpose of the investigation, detection and prosecution of serious crime.

As for clinical trials, a data retention period of at least 25 years was fixed in article 58 of Regulation (EU) 536/2014.

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