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.

P

Performance outcome (PerfO)

A performance outcome (PerfO) is a type of clinical outcome assessment (COA). A measurement based on standardized task(s) actively undertaken by a patient according to a set of instructions. A PerfO assessment may be administered by an appropriately trained individual or completed by the patient independently. PerfO assessments include:

  • Measures of gait speed (e.g., timed 25 foot walk test using a stopwatch or using sensors on ankles)
  • Measures of memory (e.g., word recall test)

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