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Trial Participation

Glossary

Academic Research Organization (ARO): An academic institution contracted by a sponsor to perform one or more research-related functions.

Acute coronary syndromes: A range of conditions that reflect reduced or absent blood flow to the heart muscle; includes angina (stable and unstable) and heart attack

Adjudication: The use of standard, objective criteria to classify events such as stroke or heart attack

Adverse drug reaction (ADR): An unintended reaction to a drug taken at a normal dose to prevent, diagnose, or treat disease or injury

Adverse event (AE): Any negative experience that a participant has during the course of a research project, including new or worsening symptoms or laboratory abnormalities

Anesthesiology: The medical study of how to eliminate pain or and sensation in people undergoing surgery or other medical procedures

Angina: Characteristic chest pain caused by reduced or absent blood flow to the heart muscle, whether predictable (stable angina) or erratic (unstable angina)

Angiogram, angiographic: Diagnostic test in which dye is injected into an artery and X-rays are taken to determine blood flow in an area; term referring to such procedures

Angioplasty: Procedure to improve blood flow: a catheter (tube) is fed along a blood vessel until it reaches the point of obstruction, then a balloon embedded in the catheter is inflated, flattening the obstruction against the blood vessel walls and increasing the area through which blood can flow

Biologic: A virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other similar product used to prevent, treat or cure disease or injury

Biomarkers: Substances in the blood whose levels can indicate the presence or extent of disease

Biostatistics: The use of statistical tests to analyze biological data

Biotechnology: The use of live organisms or substances from organisms, biological systems, or processes to make or modify products, to change plants or animals, or to develop microorganisms for specific uses

Blinding: When research participants are unaware of the assigned “treatment.” In a single-blinded study, the subjects usually do not know what treatment they are receiving. In a double-blinded study, the subjects AND the investigators are unaware of the treatment assigned, as are the monitors and statisticians in some cases. Blinded studies are conducted to prevent the bias that can occur with known treatment assignments.

Cardiac arrest: Lack of heartbeat.

Cardiology: The study of diagnosis and treatment of disorders of the heart and blood vessels

Cardiomyopathy: Disease of the heart muscle

Case Report Form (CRF): A record of information collected on each subject during the research project

Chronic: Long-term, sometimes less severe

Clinical investigation: A systematic study designed to evaluate a product (drug, device, or biologic) to treat, prevent, or diagnosis a disease or condition in humans, which can be conducted only after approval by the U.S. FDA.

Clinical research: Study of a drug, biologic, or device in human subjects

Clinical Trial Assistant (CTA): Person who assists in the day-to-day operations of a research project

Clinical study materials: Study supplies (such as study drugs, laboratory supplies, CRFs) provided to investigators

Clinical trial: Any investigation in humans meant to determine the clinical, pharmacological, pharmacokinetic, pharmacodynamic, and/or risk/benefit properties of a drug, device, or biologic

Consent: see Informed consent

Contract Research Organization (CRO): A commercial organization contracted by a client to perform one or more research-related functions

Control group: A comparison group of study participants who do not receive the study drug or intervention being tested. This group may receive no therapy, a different therapy, or a placebo.

Core Laboratory: A central facility that performs all angiographic, electrocardiographic, laboratory, or other analyses for a research project.

Data and Safety Monitoring Board (or Committee, DSMB or DSMC): A group of independent experts that review the research data periodically to ensure the safety of the participants

Data management: Collection, entering, cleaning, and processing of information gathered during a research project

Declaration of Helsinki: A series of guidelines adopted by the 18th World Medical Assembly in Helsinki, Finland in 1964. The Declaration addresses ethical issues for physicians conducting biomedical research involving humans. Recommendations include the procedures required to ensure subject safety in clinical trials, including informed consent and Ethics Committee reviews.

Device: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, that is used to diagnose, cure, treat, or prevent disease. A device does not achieve its intended purpose through chemical action or metabolism in the body.

Drug: As defined by the Food, Drug and Cosmetic Act, drugs are "articles (other than food) intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, or to affect the structure or any function of the body of man or other animals."

Echocardiogram, echocardiographic: Examination of the heart and surrounding tissue by high-energy sound waves; term referring to such procedures

Economics, health: The study of the costs and cost effectiveness of healthcare practices

Efficacy: A product's ability to produce beneficial effects on the duration or course of a disease

Electrocardiogram, electrocardiographic (ECG): Examination of the heart’s electrical activity captured through electrodes placed on the skin; term referring to such examinations

Endocrinology: Study of the function and diseases of the endocrine glands (the thyroid gland, pituitary gland, adrenal glands, etc.)

Ethics Committee: An independent group of medical and nonmedical people who verify the integrity of a study and ensure the safety, integrity, and human rights of the study participants

Exacerbation: Worsening of an existing condition or its symptoms

Exclusion Criteria: Characteristics that would prevent someone from being eligible to participate in a research project, as defined in project’s protocol

Food and Drug Administration (FDA): Within the Department of Health and Human Services, the FDA enforces the Food, Drug and Cosmetics Act and related federal public-health laws and grants approval for investigational and marketing applications

Food, Drug and Cosmetic Act (FD&C Act): Required that drugs, biologics, and devices must be proven safe and effective before they could be marketed

Gastroenterology: Study of the function and diseases of the gastrointestinal tract (esophagus, stomach, intestines, liver, etc.)

Generic drug: A medicine with the same active ingredient, but not necessarily the same inactive ingredients, as a brand-name drug. A generic drug may be marketed only after the original drug's patent has expired.

Genomics: Relating to the total set of genes carried by an individual or cell

Geriatrics: The study of function and diseases among the elderly

Glycoprotein: Structure composed of protein and sugar subunits that spans the cell membrane

Good Clinical Practices (GCPs): International ethical and scientific quality standards for the design, conduct, monitoring, recording, auditing, analysis, and reporting of studies. Ensures that the data reported are credible and accurate, and that subject's rights and confidentiality are protected.

Health Insurance Portability and Accountability Act (HIPAA): Legislation passed in 1996 that includes a privacy rule creating national standards to protect personal health information

Heart attack: death of heart muscle due to lack of blood flow, myocardial infarction

Hematology: Study of the function and disorders of the blood

Hemorrhagic: Related to bleeding

Human subject: A patient or healthy person participating in a research project

Inclusion criteria: A list of requirements that a person must meet to be eligible to participate in a research project, as specified in the protocol

Infectious disease: Disease or disorder caused by a microorganism (bacteria, viruses, fungi, etc.)

Informed Consent: The verification of a person’s willingness to volunteer in a research project. The verification is requested only after the person has received complete, objective information about the research, including its objectives, potential benefits, risks and inconveniences, alternative therapies that may be available (if applicable), and the subject's rights and responsibilities in accordance with the current revision of the Declaration of Helsinki.

Institutional Review Board (IRB): An independent group of professionals designated to review and approve the clinical protocol, Informed Consent Forms, study advertisements, and patient brochures to ensure that the study is safe and effective for human participation. The IRB also ensures that the study adheres to FDA regulations.

International Committee on Harmonisation (ICH): This alliance of the European Union, the U.S., and Japan was formed to ensure that good-quality, safe, and effective medicines are developed and registered in the most efficient and cost-effective ways. These activities are pursued to prevent unnecessary duplication of clinical trials and to minimize the use of animal testing without compromising the regulatory obligations of safety and effectiveness.

Intravenous: Within a vein

Investigational New Drug Application (IND): The application by which a manufacturer requests that the FDA allow human testing of its drug product

Investigational Device Exemption (IDE): The application by which a manufacturer requests an exemption from the FD&C Act requirements to study its medical device

Investigator: A medical professional, usually a physician but also sometimes a nurse, pharmacist, or other professional, under whose direction an investigational drug is given or dispensed. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site.

Investigator's Brochure: Relevant clinical and nonclinical data compiled on the drug, biologic, or device being studied.

Ischemia: Less-than-normal blood flow to an area of the body

Longitudinal study: A study conducted over a long period

MedWatch Program: An FDA program designed to monitor adverse events (AEs) from drugs marketed in the U.S. Health professionals report AEs voluntarily to the FDA through MedWatch. Drug manufacturers are required to report all AEs brought to their attention.

Metrics: Quantitative measures of performance or production

Monitor: Sponsor or CRO representative who reviews study records to determine that it is being conducted according to the protocol. A monitor's duties may include helping plan and initiate a study and assessing its conduct.

Monitoring: Reviewing a clinical study, ensuring that conduct, proper records, and reports are in accordance with the protocol, standard operating procedures, GCPs, and regulatory requirements

Myocardial infarction – see Heart attack

National Institutes of Health (NIH): Agency within the Department of Health and Human Services that funds research, conducts studies, and funds multicenter national studies

Nephrology: Study of the function and diseases of the kidney and related organs

Neurology: Study of the function and diseases of the nervous system and related organs

New Drug Application (NDA): Application filed by a manufacturer to market a drug in the U.S., contains all known nonclinical, clinical, pharmacological, pharmacokinetic, and stability data about the drug

Nuremberg Code: As a result of the medical experiments conducted by Nazis during World War II, the U.S. Military Tribunal in Nuremberg in 1947 set forth a code of medical ethics for researchers conducting clinical trials. The code is designed to protect the safety and integrity of study participants.

Off-label use: The use of a drug for a purpose, or at a dose, other than that approved by the FDA
Office for Human Research Protection (OHRP): U.S. government agency that issues Assurances and overseas compliance of regulatory guidelines by research institutions

Oncology: Study of cancer-related diseases

Open-label study: A study in which all parties (patient, physician, and study coordinator) are aware of the treatment assigned. In an open-label study, no participants are given placebos. These are usually Phase I or II studies.

Ophthalmology: Study of the function and diseases of the eye

Orphan Drug: FDA designation indicating a therapy developed to treat a rare disease (one that affects <200,000 people in the U.S.). Because manufacturers have little incentive to develop drugs for rare diseases, the government offers additional incentives (i.e. tax advantages and extended marketing exclusivity) for them to develop such drugs.

Otolaryngology: Study of the function and diseases of the ears, nose, and throat

Outcomes research: Evaluation that focuses on 1) the status of participants after receiving care and on 2) the process of care itself

Over-the-counter (OTC): Drugs available for purchase without a prescription

Pediatrics: Study related to the health of infants, children, and adolescents and their growth and development

Perfusion: the degree of blood flow to the area of interest (e.g., heart muscle)

Pharmacoeconomics: Study of the cost-benefit ratios of drugs with other therapies or with similar drugs, where costs include both financial and quality-of-life measures
Phase I study: The first of the four phases of clinical trials, Phase I studies are designed to establish the effects of a new drug in humans. These studies are usually conducted in small numbers of healthy volunteers to determine a drug's toxicity, absorption, distribution, and metabolism.

Phase II study: After Phase I trials, a drug is tested for safety and efficacy in slightly larger numbers of people who are afflicted with the disease or condition for which the drug is being developed.

Phase III study: The third and last round of testing before application for market of a drug is conducted on large populations of affected patients. These studies usually compare the new drug with standard therapy for the relevant disease. Phase III trials usually provide the information included in the drug’s package insert and labeling.

Phase IV study: After a drug has been approved for marketing by the FDA, Phase IV studies may be conducted to compare the drug to a competitor’s product, explore additional patient populations, or refine the safety profile of the drug.

Pilot study: A small study conducted in advance of a large one, to test the feasibility of the large study or various doses of the study drug

Pivotal study: A study, usually Phase III, that presents the data used by FDA to decide whether to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind.

Placebo: An inactive substance designed to resemble the drug being tested. It is used as a control, to increase the chance that differences in results between the groups reflect only the effects of the drug being tested.

Platelets: Cells found in blood that are critical to clotting and wound healing

Preclinical research: Safety testing of a drug conducted in vitro (in the test tube or laboratory) and in vivo (in animals), which must occur before a drug can be tested on humans

Proteomics: Research that aims to identify, quantify, and classify the function of proteins produced by given genomes

Protocol: A detailed plan that sets forth the objectives, design, and methods for a research project. A clinical study protocol must be approved by the IRB of a given center before investigational drugs can be studied in humans at that center.

Protocol amendment: Changes or clarifications made in writing to the original protocol.

Pulmonary: Related to the lungs

Psychiatry: Study of the diagnosis, treatment, and prevention of mental illness

Quality assurance: Systems and procedures designed to ensure that a study is being performed in compliance with GCPs and that the data being generated are accurate

Randomization: A method of assigning study treatment such that each participant has an equal chance of being assigned to each treatment or control group. Randomization guards against selection bias, that is, that specific criteria are used to assign patients to one group or another.

Research: Systematic investigation designed to develop or contribute to generalizable knowledge; includes clinical research

Retrospective analysis: the collection and study of data already collected for another purpose

Rheumatology: the study of diseases of inflammation and auto-immunity, such as arthritis, gout, lupus erythematosus, scleroderma, and Lyme disease

Risk-benefit ratio: The risk associated with a treatment versus its potential benefits to an individual; also called risk-benefit analysis

Serious adverse event (SAE): Any adverse event (AE) that is fatal, life-threatening, or permanently disabling, or that results in new or prolonged hospitalization

Source data: All information contained in original records and certified copies of results or observations

Source documents: Where medical information is originally recorded, including physician notes, laboratory reports, discharge summaries, autopsy reports, etc.

Sponsor: Individual, company, institution, or organization that takes responsibility for initiation, management, and financing of research

Standard Operating Procedures (SOPs): Official, detailed, written instructions for the management of clinical trials. SOPs ensure that all the functions and activities of a clinical trial are carried out consistently and efficiently.

ST segment: Portion of the electrocardiographic tracing that can indicate ischemia

Steering Committee: Group composed of the principal investigators, sponsor representatives, the study statistician(s), and others who oversee the study design, execution, analysis, and dissemination

Thrombolytic: able to break apart solid thrombus (clot); also fibrinolytic

Treatment IND: A method by which the FDA allows seriously ill patients with no acceptable therapeutic alternative access to promising Investigational New Drugs. The therapy must show "sufficient evidence of safety and effectiveness."

Unexpected Adverse Drug Reaction: A reaction that is not consistent in nature or severity with known information about the drug

Vulnerable subjects: Those who cannot give informed consent because of limited autonomy (e.g., children, mentally ill, prisoners); also refers to subjects who may be unduly influenced to participate (e.g., students, subordinates, patients)

Well-being: Subject's physical and mental soundness

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