Expertise

Glossary

Adverse Drug Reaction (ADR)

Any unintended reaction to a new treatment or drug when taken at doses typically used for diagnosis, therapy of disease, prophylaxis or for modification of physiological function, which may occur suddenly or develop over time.

Adverse Event (AE)

When a participant or patient has an undesirable or negative experience associated with a drug or treatment during a clinical trial. Adverse events can include the worsening of a pre-existing condition or the presence of symptoms that were previously unnoticed.

Bioavailability Study

A study which measures the rate and degree to which a drug is absorbed or available to the treatment site in the body.

Bioequivalence Study

A study which tests the same drug manufactured by two different companies to show that the two drugs are bioequivalent (the two drugs do not significantly differ in similar studies under similar conditions with the same dosage).

Biologic

Any substance (serum, toxin, vaccine, etc.) used to treat, prevent or cure diseases in man.

Biotechnology

The use of living organisms and their substances and other biological systems to create or change a drug or other product, to change plants or animals or to develop microorganisms.

Blinding

A procedure in which one or more parties in a clinical trial are unaware of the treatment assignments in order to decrease biases and avoid the placebo effect. See also, Single Blind and Double Blind.

Case Report Form (CRF)

A document used to record all pertinent information required by the clinical study protocol on each subject in a trial to be reported to the sponsor.

Certified Research Coordinator (CCRC)

A research coordinator with two or more years of experience and who has passed the required program and exam to earn their certification.

Clinical Investigation

See Clinical Trial

Clinical Pharmacology

The science of drugs and their clinical use in man.

Clinical Research

The study of drugs or treatments in human subjects that can be separated into therapeutic (where personal benefit is expected by the subject) and nontherapeutic (where the research is conducted to advance knowledge without the expectation of providing any benefit to the subject).

Clinical Research Associate (CRA)

A person who is employed by a sponsor or contract research organization to monitor the progress of the clinical study at all participating sites. See also, Monitor

Clinical Research Coordinator (CRC)

A person who manages the majority of the administrative duties of a clinical trial. These duties, such as reviewing all data and records, are assigned by the investigator.

Clinical Study Materials

A complete set of study supplies such as study test article, laboratory supplies, case report forms, etc. given to an investigator by the sponsor.

Clinical Trial/Study

A systematic study used to evaluate a drug, treatment or device in one or more human subjects in the treatment, prevention or diagnosis of a disease or condition. This investigation is used to determine or confirm the clinical, pharmacological, pharmacokinetic and/or other pharmacodynamic effects of the investigational products, as well as identify any adverse reactions to determine their safety and efficacy.

Co-hort

Group of subjects in a clinical trial with some characteristics in common who are followed up at standard, preset intervals.

Consent Forms

A document that outlines all the potential risks, benefits and relevant information about a clinical study to the volunteer or participant. This document also details the involved parties’ rights and responsibilities. This document is signed by the volunteer/participant.

Control Group

The group of individuals in a clinical study who do not receive the new treatment or drug, but instead are administered no treatment, an existing treatment or placebo. The control group is the standard by which experimental observations are measured and evaluated.

Controlled Study

A study in which a new drug or treatment is tested against a treatment with known effects. One group receives the new treatment, while the other group receives no treatment, a standard treatment or a placebo.

Crossover Study

A study in which each participant receives both treatments, the new treatment and the control, in a randomized order so that treatment comparisons can be made within each participant.

Data Management

The process by which data is handled and monitored during clinical studies.

Declaration of Helsinki

The international standard of guidelines for the protection of clinical trial participants’ rights, adopted by the 18th World Medial Assembly in 1964. These basic principles are designed to guide physicians conducting biomedical research involving human subjects.

Demographic Data

Characteristics of subjects including sex, age, family medical history and other characteristics pertinent to the study in which they are participating.

Device

An instrument, apparatus, machine, implement or similar article designed for use in the diagnosis, treatment, prevention or cure of a disease or condition.

Documentation

All records, in any form, that describe or document methods, conduct and results of a study.

Dosage Regimen

The schedule of doses, including the number of doses given in a time period; the elapsed time between each administered dose, or the time at which the doses are given; and the amount of medicine administered at each dosing time.

Double-Blind

A clinical study in which neither the investigators nor the participants are aware of which treatment (the new treatment vs. the control) a subject is receiving as to produce objective results and reduce any potential biases from any involved parties.

Drug

A substance (other than food) used in the diagnosis, treatment, cure or prevention of disease; used to enhance mental or physical well-being; or used to affect the function or structure of the body in humans or animals.

Drug Product

The finished dosage form (i.e. capsule, tablet, solution, etc.) that contains a drug substance in combination with other active or inactive ingredients.

Effective Dose

The dose of an investigational drug or treatment that produces the desired outcome considered effectual as outlined by the study protocol.

Efficacy

A drug or treatment’s maximum ability to produce beneficial results regardless of dosage on the course or duration of a disease or condition.

Ethics Committee

See Institutional Review Board

Exclusion Criteria

A list of characteristics or criteria, any one of which that would exclude a participant from a clinical study as outlined in the study protocol.

Experimental Drug

A drug that is not licensed by the FDA for use in humans or as a treatment for any disease or condition