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.

L

Local Site Investigator

A local site investigator is a medical professional who is responsible for conducting a clinical trial at a specific site or location. The local site investigator is responsible for recruiting and enrolling participants in the trial, collecting and analyzing data, and ensuring that the trial is conducted in accordance with the study protocol and all applicable regulations and guidelines. In the context of central imaging in a clinical trial, the local site investigator may be responsible for collecting medical imaging data from participants and submitting it to the central review facility for analysis and interpretation.

See Investigator.

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