Glossary

Discover full dictionary

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510 K
A
Accountability
A
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)
B
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.

Data protection authority

A data protection authority (DPA) is an independent body which is in charge of:

  • monitoring the processing of personal data within its jurisdiction (country, region or international organization);
  • providing advice to the competent bodies with regard to legislative and administrative measures relating to the processing of personal data;
  • hearing complaints lodged by citizens with regard to the protection of their data protection rights.

According to Article 51 of the GDPR, each Member State shall establish in its territory at least one data protection authority, which shall be endowed with investigative powers (such as access to data, collection of information, etc.), corrective powers (power to order the erasure of data, to impose a fine or a ban on processing, etc.), and authorisation or advisory powers (issuance of opinions, power to accredit certification bodies, etc.). The EDPS is established as an independent data protection authority at EU level by Article 52 of Regulation (EU) 2018/1725.

National data protection authorities have been established in all European countries, as well as in many other countries worldwide.

Also see Supervisory authority.

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