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Recruiting

The clinical study is currently recruiting participants. A type of Recruitment Status.

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Randomization

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

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Randomized Allocation

A strategy in which participants are assigned to arms of a clinical trial by chance. A type of Allocation.

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Quality-Adjusted Life Years (QALY)

A widely accepted measure of utility that combines duration of survival with quality of survival. (Pfizer)

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Quality Control

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

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Quality Assurance

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and […]

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Pure Food and Drugs Act

Legislation passed in 1906 that focused on the prevention of food adulteration. It also created the FDA. (Pfizer)

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Publications

Published scientific articles or abstracts about a clinical study. A publication reference, also called a citation, may be submitted to ClinicalTrials.gov at any time. It can also be automatically identified […]

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Protocol Amendment

A written description of a change(s) to or formal clarification of a protocol. (Pfizer)

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Privacy

See  Personally Identifiable Information (PII).

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