Category: P

Protocol

The written description of a clinical study. It includes the study’s objectives, design, and methods. It may also include relevant scientific background and statistical information.

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Principal Investigator

The person who is responsible for the scientific and technical direction of the clinical trial at a specific clinical site. In most cases the principal

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Placebo

An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.

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Pivotal Clinical Trial

A clinical study designed & executed to get statistically significant evidence of efficacy and safety in order to obtain its marketing approval by regulatory authorities.

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Phase 4

A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that

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Phase 3

A phase of research to describe clinical trials that gather more information about a drug’s safety and effectiveness by studying different populations and different dosages

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Phase 2

A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that

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Phase 1

A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the

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Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The

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Pharmacokinetics

The processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine. Source: NLM

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Patient Registry

A type of observational study that collects information about patients’ medical conditions and/or treatments to better understand how a condition or treatment affects patients in

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Priority Review

[FDA] Designation given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists, where the time it takes

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Predicate Rule

[FDA] A previously published set of rules with the exception of part 11 (such as GLPs, GCP, or cGMPs) that mandate what records must be

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Pharmacopoeia

A pharmacopoeia is a book describing drugs, chemicals, and medicinal preparations which is issued by an officially recognized authority and serves as a standard.

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