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.

C

Clinical Trials Information System (CTIS)

The Clinical Trials Information System (CTIS) is a unified European system, which all sponsors must use to obtain the authorization for their clinical trials. The authorization is delivered through the platform by the responsible Member State. This system increases the transparency and availability of information on clinical trials and their results as it makes data accessible to the public.

The CTIS includes the EU portal, the EU Database and a module for the submission of Annual Safety Reports. The EU Portal is the single entry point for the submission of data and documents relating to clinical trials. The EU Database contains data and documents submitted via the EU Portal. A part of this database is publicly available.

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