Page 25 - Terminology-Clinical-Research

is responsible for protecting the public health by making and Drug Administration, Centers for Disease Control
sure that human and veterinary drugs, vaccines and other and Prevention, U.S. Department of Veterans Affairs); 3.
biological products, medical devices, the Nation’s food Industry (pharmaceutical and device companies); and,
supply, cosmetics, dietary supplements, and products that 4. All others (including individuals, universities, and
give off radiation are safe, effective, and secure. community-based organizations).

Forest plot (FP): Where there are a number of studies Fusion proteins: Proteins created through the joining
that have looked at a treatment, or subgroups of patients of two or more genes which were originally coded for
within one study that may respond differently to treatment, separate proteins.
a forest plot (FP) is a way to show and compare different
groups of data. FWA: Federal wide Assurance.

Form: A collection of items and item groups for capturing
and displaying clinical trial data.

Formulation (formulation of a drug): The chemical G
composition of the final medicinal product which includes
the active ingredient as well as other ingredients (non-
medicinal ingredients).
Gas chromatography (GC): A process by which the
Frequentist methods: Statistical methods, such as components of a mix are separated from one another
significance tests and confidence intervals, which can be by volatilizing the sample into a carrier gas stream and
interpreted in terms of the frequency of certain outcomes passing the gas through a column containing a substance
occurring in hypothetical repeated realizations of the same that selectively retains (adsorbs) and releases the volatile
experimental situation. constituents.

Frozen: Status of a database, file, or element that has been Gender: Subject self-identification re: masculine/feminine.
presumed to be in its final state pending “lock” and where Genders eligible for study: The physical gender of people
further editing is prevented without “unfreezing.” Note: who may participate in a clinical study (Female, Male, or
Freezing and unfreezing are usually formalized in audit Both).
trails and differ from “locking” and “unlocking” only in the
degree of approval required. Gene therapy medical product: Product aimed at the
transfer of a prophylactic, diagnostic or therapeutic gene to
Full analysis set: The set of subjects that is as close as human and its subsequent expression in vivo.
possible to the ideal implied by the intention-to treat
principle. It is derived from the set of all randomized Gene therapy: A technique for the treatment of genetic
subjects by minimal and justified elimination of subjects. disease in which a gene that is absent or defective is
replaced by a healthy gene.
Full title of the trial: The title as specified in the study
protocol and other documents submitted as part of the Generalizability: The extent to which the findings of a
Clinical Trial Application. clinical trial can be reliably extrapolated from the subjects
who participated in the trial to a broader patient population
Functional name of contact point: The point of contact and a broader range of clinical settings.
for further information on the trial (e.g. “Clinical Trial
Information Desk”). Generic drugs: A medicine with the same active
ingredient, but not necessarily the same inactive
Functional role (in a study): See Role.
ingredients, as a brand-name drug. A generic drug may be
Funder type: Describes the organization that provides marketed only after the original drug’s patent has expired.
funding or support for a clinical study. Support may include Generic name: The drug identifying name to which
providing facilities, expertise, or financial resources. all branded (proprietary) names for that indication are
Organizations listed as Sponsors and Collaborators for a associated.
study are considered the funders of the study. There are
four types of funders: 1. National Institutes of Health; Global assessment variable: A single variable, usually
2. Other U.S. Federal agencies (for example, the Food a scale of ordered categorical ratings, which integrates

TERMINOLOGY CLINICAL RESEARCH 25