Glossary

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510 K
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Accountability
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Accuracy
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Ad-Hoc Services
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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
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Article 29 Working Party
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Artificial Intelligence
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Automated individual decision
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Auxiliary medicinal product
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Best-in-class drugs
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Binding corporate rules (BCR)
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Biometric data
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Biotechnology
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Central Laboatory
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Central imaging
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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.

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Accountability

Accountability is a principle intended to ensure that controllers are more generally in control and in the position to ensure and demonstrate compliance with data protection principles in practice. Accountability requires that controllers put in place internal mechanisms and control systems that ensure compliance and provide evidence – such as audit reports – to demonstrate compliance to external stakeholders, including supervisory authorities.

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