GLOSSARY

Adverse Drug Reaction

An unintended reaction to a drug taken at normal doses

Adverse Event (AE)

An untoward medical occurrence in a study subject administered a pharmaceutical product; it does not necessarily have a causal relationship with this treatment.

Beneficence

Doing no harm.  Maximizing benefits while minimizing risks.

Biologic

A virus, vaccine, toxin, antitoxin, blood product, therapeutic serum or similar material for the prevention, treatment or cure of disease or injury in humans.

Biotechnology

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

Blinding

The process through which study subjects, the investigator and/or other involved parties in a clinical trial are kept unaware of the treatment assignments of study subjects.

Case Report Form (CRF)

A record of pertinent information collected on each subject during a clinical trial, based on the protocol.

Certified Clinical Investigator

A clinical investigator who meets required experience and educational levels and has earned certification by passing an exam.

Certified Clinical Research Coordinator (CCRC)

CRC with more than two years experience and certification earned by passing an exam.

Clinical Trial (clinical study, clinical investigation)

Any experiment that involves a test article (drug, device, biologic) and one or more human subjects.

Clinical Research Associate (CRA)

The sponsor monitor who visits sites periodically during a study to monitor the data and assess progress.

Clinical Research Coordinator (CRC) (Study Coordinator)

The person at an investigational site who manages the daily operations of a clinical investigation and who is responsible to the investigator.

Clinical Research Organization or Contract Research Organization

A person or entity that assumes, as an independent contractor with the sponsor, one or more of the obligations of the sponsor.

Control Group

A group of subjects who are not treated with the investigational product.  This group is used as a comparison to the treatment group.

Data Management

The process of handling the data generated and collected during a clinical trial, usually including data entry and database management.

Demographic Data

The characteristics of study subjects, including age, sex, medical history and other information relevant to the stud.

Device

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis, cure, treatment or prevention of disease.  A device does not achieve its intended purpose through chemical action in the body and is not dependent upon being metabolized to achieve its purpose.

Double-Blind

The design of a study in which neither the investigator nor the subject knows which treatment the subject is receiving.

Drug

An article (other than food) intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals.

Efficacy

A test product’s ability to produce a beneficial effect on the duration or course of a disease.

FDA

The United States Food and Drug Administration.

Generic Drug

A medicinal product with the same active ingredient(s) as a brand name drug.  Generic products may only be marketed after the original drug’s patent has expired.

Good Clinical Practice (GCP)

The regulations and guidelines that specify the responsibilities of sponsors, investigators, monitors, and IRBs involved in clinical trials.  They are meant to protect the safety, rights and welfare of the subjects in addition to ensuring the accuracy of the data collected during the trial.

Human Subject

An individual who participates in research, either as a recipient of the test article or as a control.  A subject may be either a healthy subject or a patient.

Inclusion and Exclusion Criteria

The characteristics that must be present (inclusion) or absent (exclusion) in order for a subject to qualify for a clinical trial, as per the protocol for the trial.

Informed Consent

The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial.

Institutional Review Board (IRB)

Any board, committee, or group formally designated to review biomedical research involving humans as subjects, to approve the initiation of and conduct periodic review of such research.

Investigator (Clinical Investigator {CI}, Principal Investigator {PI})

An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is dispensed, or, in the case of an investigation conducted by a team of individuals, is the responsible leader of that team.

Investigator Brochure

A compilation of all information known to date about the test product, including chemistry and formulation information and preclinical and clinical data.  It is updated at least annually.  Once the product is marketed, it is replaced by the labeling (package insert) for the product.

Investigation New Drug

A new drug or biologic that is used in a clinical investigation

Investigational New Drug Application (IND)

The application to start clinical testing of a new drug, biologic or device in humans.

In Vitro Testing

Non-clinical testing conducting in an artificial environment such as a test tube or culture medium.

In Vivo Testing

Testing conducted in living animal and human systems.

IRB Approval

The determination of the IRB that the clinical investigation has been reviewed and may be conducted within the constraints set by the IRB and applicable regulations.

Legally Authorized Representative

An individual or judicial or other body authorized under applicable law to consent on behalf of a potential subject to the subject’s participation in research.

Medical Monitor (Sponsor Medical Monitor)

The physician at the sponsor who is responsible for the clinical investigation of a test product.

Minimal Risk

The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or in the performance of routine physical or psychological examination or tests.

New Drug Application (NDA)

The marketing application for a new drug submitted to the FDA.  The NDA contains all the nonclinical, clinical, pharmacological, pharmacokinetic, and stability data required by the FDA.

Open Label Study

A study in which the subjects and the investigator are aware of the drug that is being administered.

Placebo

An inactive substance designed to resemble the drug being tested.

Preclinical Testing

Studies conducted on animals to determine that the drug is safe to use in studies on humans.

Protocol

The formal plan for carrying out a clinical investigation.

Quality Assurance

Systems and procedures designed to ensure that a study is being performed in accordance with Good Clinical Practice (GCP) guidelines and that the data being generated are accurate.

Randomization

A method in which study subjects are randomly assigned to treatment groups.  It helps to reduce bias in a trial by ensuring that there is no pattern in the way subjects are assigned to treatment groups.

Serious Adverse Events (SAE)

Any untoward medical occurrence at any dose that results in death, is life-threatening, requires hospitalization (or prolongation of hospitalization in a patient who is already hospitalized), results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.

Site Management Organization (SMO)

A group of investigational sites that have banded together and organized centrally to do studies.

Sponsor

The person or entity who initiates a clinical investigation, but who does not actually conduct the investigation.

Standard Operating Procedures (SOP)

Official written instructions for the management and conduct of clinical trial processes.  SOPs ensure that processes are carried out in a consistent and efficient manner.

Study Coordinator (Clinical Research Coordinator)

The person at an investigational site who manages the daily operations of a clinical investigation and who is responsible to the investigator.

Sub-Investigator

Any member of an investigational team other than the investigator.

Test Article

Any drug, biologic, or device being tested for use in humans.

Unanticipated Event

Problem involving risks to human subjects or others participating in a clinical research study, e.g., breach of confidentiality, incarceration of subject, suicide attempt, incorrect labeling of study drug.  These too, need to be collected and reported.