Glossary

Discover full dictionary

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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
B
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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Accuracy

Accuracy is a data protection principle. Organizations must take every reasonable step to ensure the data processed is accurate and, where necessary, kept up to date. Reasonable measures should be understood as implementing processes to prevent inaccuracies during the data collection process as well as during the ongoing data processing in relation to the specific use for which the data is processed. The organization must consider the type of data and the specific purposes to maintain the accuracy of personal data in relation to the purpose. Accuracy also embodies the responsibility to respond to data subject requests to correct records that contain incomplete information or misinformation (see right of rectification).

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