Glossary

An application architecture that takes advantage of local processing power of client PCs. Data storage is centralized or distributed among one or more server, while some of all processing occurs on the user’s PC.

An indicator (such as blood pressure) measured in a human subject to asses the safety, efficacy, or other objective of a clinical trial.

The temporary cessation of a clinical trial by FDA if the agency is concerned about a drug or study protocol. The trial may resume when the problem is solved.

Any experiment that involves a test article and one or more human subjects that is subject to FDA requirements for research or marketing permits (21 CFR Part 50.3(c) and 56.102(c)).

Studies performed in humans that are intended to increase knowledge about how well a diagnostic test or treatment works in a particular patient population.

Person employed by a sponsor, or by a contract research organization acting on a sponsor’s behalf, who monitors the progress of investigator sites participating in a clinical study. At some (primarily academic) sites, clinical research coordinators are called CRAs.

Person who handles most of the administrative responsibilities of a clinical trial, acts as liaison between investigative site and sponsor, and reviews all data and records before a monitor’s visit. Synonymous: Trial Coordinator, Study Coordinator, Research Coordinator, Clinical Coordinator, Research nurse, Protocol Nurse.

Human studies that are designed to measure the efficacy of a new drug or biologic. Clinical studies routinely involve the use of a placebo group that is given an inactive substance that looks like the test product.

A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.

Any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s) and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of one or more investigational medicinal product(s) with the object of ascertaining its/their safety and/or efficacy. (Synonym for or subject of Clinical Study)

Any systematic study of pharmaceutical products in human subjects, whether in patients or other volunteers, in order to discover or verify the effects of, and/or identify any adverse reaction to, investigational products, and/or to study the absorption, distribution, metabolism and excretion of the products with the object of ascertaining their efficacy and safety.

Any systematic study of pharmaceutical products in human subjects.

Regulatory submission to allow execution of a clinical trial, e.g., CTA, IND, etc.

The set of documents required by a competent authority at the time the clinical trial authorization application is submitted.

The testing material used in a clinical trial, including the primary study drug, comparator drugs, and placebo as specified in the study protocol. Clinical trial material includes any investigational product, including medical devices, designed for human use.

Packaged and labeled drug product including placebos and comparators intended for use in a clinical trial. May also be referred to as Investigational Medicinal Product (IMP).

Also known as Drug Trials. Testing of INDs (Investigational New Drugs) in human subjects to prove safety and efficacy prior to the drug’s approval for marketing. The investigation of a previously untested drug is generally divided into: (Phase 1) application in humans through limited and broad clinical tests (Phase 3), to postmarketing studies (Phase 4).Phase 1 Drug Trial: Phase 1 trials include the initial introduction of an investigational new drug into humans. These studies are typically conducted with healthy volunteers; sometimes, where the drug is intended for use in patients with a particular disease, however, such patients may participate as subjects. Phase 1 trials are designed to determine the metabolic and pharmacological actions of the drug in humans, the side effects associated with increasing doses (to establish a safe dose range), and, if possible, to gain early evidence of effectiveness; they are typically closely monitored. The ultimate goal of Phase 1 trials is to obtain sufficient information about the drug's pharmacokinetics and pharmacological effects to permit the design of well-controlled, sufficiently valid Phase 2 studies. Other examples of Phase 1 studies include studies of drug metabolism, structure-activity relationships, and mechanisms of actions in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. The total number of subjects involved in Phase 1 investigations is generally in the range of 20-80. Phase 2 Drug Trial: Phase 2 trials include controlled clinical studies conducted to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug. These studies are typically well-controlled, closely monitored, and conducted with a relatively small number of patients, usually involving no more than several hundred subjects. Phase 3 Drug Trial: Phase 3 trials involve the administration of a new drug to a larger number of patients in different clinical settings to determine its safety, efficacy, and appropriate dosage. They are performed after preliminary evidence of effectiveness has been obtained, and are intended to gather necessary additional information about effectiveness and safety for evaluating the overall benefit-risk relationship of the drug, and to provide and adequate basis for physician labeling. In Phase 3 studies, the drug is used the way it would be administered when marketed. When these studies are completed and the sponsor believes that the drug is safe and effective under specific conditions, the sponsor applies to the FDA for approval to market the drug. Phase 3 trials usually involve several hundred to several thousand patient-subjects. Phase 4 Drug Trial: Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use. These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. 21CFR312.85 "Phase 4 Studies".

Constant Level Loading (Lyophilizer)

Chemiluminescent Nitrogen Detection

(ISO) A device that generates periodic, accurately spaced signals used for such purposes as timing, regulation of the operations of a processor, or generation of interrupts.

The production of a population of plasma cells all producing the same antibody in response to the interaction between a B lymphocyte producing that specific antibody and the antigen bound by that antibody.

A group of individuals produced from one individual through asexual processes that do not involve the interchange or combination of genetic material. As a result, members of a clone have identical genetic compositions. Protozoa and bacteria, for example, frequently reproduce asexually by a process called binary fission. In binary fission, a single-celled organism undergoes cell division and the result is two cells with identical genetic composition. Next, these two identical cells undergo division and the result is four cells with identical genetic composition. These identical offspring are all members of a clone.

A population of genetically identical cells derived from the multiplication of a single cell. It is the basis of rDNA and monoclonal antibody production. Cloning of genes and cells to create many copies in the laboratory is a common procedure essential for biomedical research.

1. The mitotic division of a progenitor cell to give rise to a population of identical daughter cells or clones.2. Incorporation of a DNA molecule into a chromosomal site or a cloning vector.3. Animal cloning: the creation of a whole animal by mitotic divisions from a single diploid somatic cell typically by the process of nuclear transfer. Cloning by nuclear transfer from undifferentiated embryonic cells has been possible for many years, but its widespread application has been hampered by inability to culture embryonic cells from animals other than mice. In 1997, Ian Wilmut and colleagues from Edinburgh showed that it is possible to create a whole animal from a cell taken from differentiated adult tissue, thereby opening up the possibility of widespread animal cloning.