Clinical Research Dictionary

Baby Boom

The period from the end of World War II through the mid-1960s marked by unusually high birth rates.

Balanced Study

Trial in which a particular type of subject is equally represented in each study group. bandwidth An indicator of the throughput (speed) of data flow on a transmission path; the width of the range of frequencies on which a transmission medium carries electronic signals. All digital and analog signals have a bandwidth.

Bar Code

A pattern of black vertical lines with information coded in the relative widths of the black lines to uniquely identify and/or track clinical supplies (e.g., case report forms, medication containers).

Base

A number or value used as a standard or reference against which other values are compared.

Baseline

The time point when a clinical trial starts, before any treatment is begun. Researchers often compare baseline tests to those made at the end of the study to see how well the treatments worked.

Baseline Assessment

The evaluations that are conducted on subjects as they enter a clinical trial before any investigational product or interventions are given.

Baseline Data

Data collected for certain clinical parameters (study specific) performed on clinical trial subjects usually prior to treatment. In cases where test results may show clinical variability, the tests may be performed more than once so that the results can be averaged for a control measurement less affected by random fluctuations.

Batch (in relation to US manufacturing)

A defined quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

Bayesian Statistics

Statistical approach named for Thomas Bayes (1701–1761) that has among its features, giving a subjective interpretation to probability, accepting the idea that it is possible to talk about the probability of hypotheses being true and of parameters having particular values.

Belmont Report

A document that is part of the Federal Register that sets forth fundamental ethical principles that form the foundation for rules for all government funded research involving human subjects. The three basic ethical principles are: (1) respect for persons (2) beneficence, and (3) justice.

http://ohsr.od.nih.gov/mpa/belmont.php3

Benchmarking

A standard of excellence or achievement against which similar things are measured or judged.

Beneficence (in relation to the Belmont Report)

Obligation to protect persons from harm, emphasizing 2 general rules:
(1) Do not harm
(2) Maximize possible benefits and minimize possible harms

Benefit

A valued or desired outcome; an advantage

Benefit-Risk Assessment

See Risk-Benefit Ratio

Best Interest (in terms of Subject)

The burden to the individual resulting from participation in research are determined by the individual's legally authorized representative to be reasonable in relation to the individual resulting from individual's participation in research.

Beta Error

In a Neyman-Pearson test of a statistical hypothesis, the probability of accepting the null hypothesis when it is false; the complement of the power of the test.

See also Type 2 Error.

Between-Subject Variation

In a parallel trial design, differences between subjects are used to assess treatment differences.

Bias

A slanted perspective that prevents researchers from getting true answers to research questions. Clinical trials use several methods to eliminate bias, including randomization, blinding, and the use of strict protocols.

Bioanalytical Assays

Methods for quantitative measurement of a drug, drug metabolites, or chemicals in biological fluids.

Bioavailability

BA

The rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.

21 CFR 320.1

Bioequivalence

BE

The absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.

21 CFR 320.1

Biologic

Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic products, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man.

Biological Safety Officer

BSO

An individual appointed by an institution to oversee management of biosafety risks.

Biologics Control Act of 1902

US Legislation requiring that biological drugs be licensed and produced in licensed facilities.

Biometrics (in relation to Electronic Records)

A method of verifying an individual’s identity based on measurement of the individual’s physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.

21 CFR 11.3

Biometrics and Outcomes Research Core

BORC

A core within the School of Public Health that provides expertise in clinical trial design, outcomes research, quality of life research, database management and data analysis for multi-center clinical trials and multi-disciplinary research.

http://www.med.umich.edu/borc/

Biometric Identifier

An identifier based on some physical characteristic, such as a fingerprint.

Biologic

Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.

Biological Product

Any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man.

21 CFR 600.3

Biologics License Application

BLA

Current term for an application for a new biological product submitted to the FDA, specifically CBER, under the Public Health Service Act for review and approval prior to marketing in interstate commerce.

21 CFR 314.3

Biomedical Research Council

BMRC

A University of Michigan committee that encourages biomedical research and facilitates interdisciplinary research and training across the university.

http://www.med.umich.edu/medschool
/orgs/bmrc/

Bioresearch Monitoring

BIMO

An FDA compliance program: 1.) to ensure the quality and integrity of data and information submitted in support of investigational and marketing clearance applications or submissions; and 2.) to ensure that human subjects taking part in investigations are protected from undue hazard or risk, by direct site monitoring of sponsors, institutional review boards, clinical investigators, and nonclinical laboratories involved in the testing of investigational products.

http://www.fda.gov/ora/compliance_ref
/bimo/default.htm

Biosafety Level

BL

A description of the degree of physical containment being employed to confine organisms containing recombinant DNA molecules and to reduce the potential for exposure of laboratory workers, persons outside of the laboratory, and the environment.

Biostatistics

Branch of statistics applied to the analysis of biological phenomena.

Biotechnology

Any technique that uses living organisms, or substances from organisms, biological systems, or processes to make or modify a product or process, to change plants or animals, or to develop micro-organisms for specific uses.

Birthing Center

A facility, other than a hospital's maternity facilities or a physician's office, which provides a setting for labor, delivery, and immediate postpartum care as well as immediate care of new born infants.

Blacklist

The common name of a list published by the FDA of investigators who are prohibited for reasons of misconduct or negligence from conducting studies under INDs. The FDA publishes the list in the Federal Register.

Blind

See Blinding

Blinded Medications

Products that appear identical in size, shape, color, flavor, and other attributes to make it very difficult for subjects and investigators to determine which medication is being administered.

Blinded Study Design

Study designs comparing two or more interventions in which either the investigators, the subjects, or some combination thereof do not know the treatment group assignments of individual subjects.

Blinding

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single blinding usually refers to the subject(s) being unaware, and double blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).

See Single Blind, Double Blind, and/or Triple Blind

ICH E6 1.10

Block

In randomization schemes, a group of subjects.

Block Size

In comparative multi center trials, treatments are randomly organized in smaller fixed size groups to ensure that an approximately equal total number of subjects receive each study treatment even if each center does not recruit its full quota of subjects.

Blood Urea Nitrogen

BUN

The term BUN refers to the substance urea, which is the major breakdown product of protein metabolism, and is ordinarily removed by the kidneys. During kidney failure, ure accumulates in proportion to the degree of kidney failure and to the amount of protein breakdown. The symptoms of uremia correspond roughly to the amount of urea in the blood stream.

Board-Certified

This means a doctor has special training in a certain area of medicine and has passed an advanced exam in that area of medicine. Both primary care doctors and specialists may be board-certified.

Body Surface Area

BSA

The total surface area of the human body. The BSA is used in many measurements in medicine, including the calculation of drug dosages and the amount of fluids to be administered IV.

Breakthrough Drug

A new therapeutic compound whose therapeutic effects and/or mechanism of action are substantially different from any previously marketed compound.

British Association of Research Quality Assurance

BARQA

Formed in 1977 as the Quality Assurance Group of the United Kingdom or QAG (UK), and renamed the British Association of Research Quality Assurance in 1991, the primary purpose of BARQA is to assist members in the understanding, interpretation and implementation of national and international regulations covering Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP). Since its inception the Association has grown and developed to reflect the changes taking place in regulatory requirements, government inspections and the needs of industry.

http://www.barqa.com/

British National Formulary

BNF

The BNF is not an official formulary but it is a listing that provides practical guidance on drug prescribing for doctors and pharmacists. It is produced jointly by the Bristish Medical Association and the Pharmaceutical Society of Great Britain, with a new edition published every six months.

Broad Agency Announcement

BAA

A means of soliciting proposals for basic and applied research and that part of development not related to the development of a specific system or hardware procurement. BAAs may be used by agencies to fulfill their requirements for scientific study and experimentation directed toward advancing the state-of-the-art or increasing knowledge or understanding rather than focusing on a specific system or hardware solution.

Browser

Computer program that runs on the user’s desktop computer and is used to navigate the World Wide Web.

See also Web browser

Budget (in relation to Study Budgets)

The amount of money designated by a sponsor for conducting a clinical study. Budgets usually include a per subject cost that factors in professional fees for the investigator and study staff, costs of clinical tests, laboratory fees, admistrative overhead, etc.

Bulk Drug Requistion

BDR

The request for unprocessed quantities of "raw" material for a clinical investigation, which may subsequently provide packaged medication for one or more clinical protocols.

Bulk Drug Supplies

Unprocessed quantities of "raw" drug. For example, bulk drug might be contained in fifty-gallon drums before being formulated into tablets or capsules and packaged in containers, blister packs, vials, etc.

Bulk Subtance

Raw material used in the manufacture of a study drug.

Bundesgesundheitsamt

BGA

The German regulatory agency that oversees the testing of investigational drugs, biologics, therapeutics, and devices and that decides on marketing applications. In addition, the BGA is responsible for safety of marketed drugs, control of epidemics and addictions, and medicostatistics.

Business Associate (in relation to HIPAA)

A person or organization that uses protected health information (PHI) to perform a function or activity on behalf of a covered entity, but is not part of the covered entity's workforce.

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