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Glossary of Human Subjects Terminology
(Printed with Permission
from Stanford University)
Select the first letter of
the word from the list above to jump to appropriate section of
the glossary. If the term you are looking for starts with a digit
or symbol, choose the '#' link.
Abdominal
pertaining to body cavity below diaphragm which contains
stomach, intestines, liver, and other organs.
Absorb take up fluids, take in.
Acidosis condition when blood contains more acid
than normal.
Acuity clearness, keenness, esp of vision -
airways.
Acute new, recent, sudden.
Adenopathy swollen lymph nodes (glands).
Adjuvant helpful, assisting, aiding.
Adjuvant Treatment added treatment.
Antibiotic drug that kills bacteria and other
germs.
Antimicrobial drug that kills bacteria and other
germs.
Antiretroviral drug that inhibits certain viruses.
Adverse Effect negative side effect.
Allergic Reaction rash, trouble breathing.
Ambulate ability to walk.
Ambulation, Ambulatory ability to walk.
Anaphylaxis serious, potentially life threatening
allergic reaction.
Anemia decreased red blood cells; low red blood
cell count.
Anesthetic (general) adrug or agent used
to decrease the feeling of pain or eliminate the feeling
of pain by putting you to sleep.
Anesthetic (local) a drug or agent used to
decrease the feeling of pain or by numbing an area of
your body, without putting you to sleep.
Angina pain resulting from insufficient blood to
the heart.
Angina Pectoris same as above.
Anorexia condition in which person will not eat;
lack of appetite.
Antecubital area inside the elbow.
Antibody protein made in the body in response to
foreign substance; attacks foreign substance and protects
against infection.
Anticonvulsant drug used to prevent seizures.
Antilipidemic a drug that decreases the level of
fat(s) in the blood.
Antitussive a drug used to relieve coughing.
Arrhythmia any change from the normal heartbeat (abnormal
heartbeat).
Aspiration fluid entering lungs.
Assay lab test.
Assess to learn about.
Asthma a lung disease associated with tightening
of the air passages.
Asymptomatic without symptoms.
Axilla armpit.
Benign
not malignant, usually without serious consequences, but
with some exceptions e g benign brain tumor may have,
serious consequences.
BID twice a day.
Binding/Bound carried by, to make stick together,
transported.
Bioavailability the extent to which a drug or
other substance becomes available to the body.
Blood profile series of blood tests.
Bolus an amount given all at once.
Bone Mass the amount of [calcium in a give amount
of] bone.
Bradyarrhythmias slow irregular heart beat.
Bradycardia slow heartbeat.
Bronchospasm breathing distress caused by
narrowing of the airways.
Carcinogenic
capable of causing cancer.
Carcinoma type of cancer.
Cardiac pertains to the heart.
Cardioversion restoration of normal heart beat by
electric shock.
Catheter a tube for withdrawing or introducing
fluids.
Catheter-(indwelling epidural) a tube placed near
the spinal cord used for anesthesia during operation.
Central Nervous System (cns) brain and
spinal cord.
Cerebral trauma damage to the brain.
Cessation stopping.
CHD coronary heart disease.
Chemotherapy treatment of disease, usually cancer,
by chemical agents.
Chronic continuing for a long time.
Cisplatin a drug used to kill cancer cells.
Clinical pertaining to medical care.
Clinically Significant of major importance
for treating or evaluating patients.
Clinical trial an experiment in patients.
Coma unconscious state.
Complete response total disappearance of disease.
Congenital occurring prior to birth, due to
parent's genetic input.
Conjunctivitis irritation and redness of the thin
membrane covering the eye.
Consolidation Phase treatment phase
intended to make a remission permanent, follows
induction.
Controlled Trial study in which the experimental
treatment or procedure is compared to a standard
(control) treatment or procedure.
Cooperative Group association of multiple
institutions to perform clinical trials.
Coronary pertains to the blood vessels that supply
the heart.
Ct (Cat) Scan computerized (axial) tomography;
computerized series of x-rays culture test for infection
or organisms that could cause infection.
Cumulative total sum (of individual events,
experiences, treatments).
Cutaneous relating to the skin.
CVA cerebrovascular accident; stroke.
Dermatologic
pertaining to the skin.
Diastolic lower number in blood pressure reading;
pertaining to resting or relaxation phase of heart beat.
Distal toward the end, away from the center of the
body.
Diuretic water pill or drug that causes increase
in urination.
Doppler sound waves.
Double blind study in which neither investigators
nor subjects know what drug the subject is receiving.
Dysfunction state of improper function.
Dysplasia abnormal cells.
Echocardiogram
sound wave test of the heart.
Edema increased fluid.
EEG electroencephalogram; electric brainwave
tracing.
Efficacy effectiveness.
Electrocardiogram electrical tracing of the
heartbeat or heart rhythm (ECG or EKG).
Electrolyte Imbalance imbalance of salts or
chemicals in the blood.
Elevation of Liver Function Tests evidence of
liver or kidney damage.
Emesis vomiting.
Empiric based on experience.
Endoscopic Examination examination of an internal
part of the body with a lighted tube; looking at a part
of the body with a lighted tube.
Enteral by way of the intestines.
Epidural outside the spinal cord.
Eradicating getting rid of (such as a disease).
Evaluated assessed; examined for medical
condition.
Expedited Review rapid review of a protocol by
human subjects committee chair without full committee
approval, permitted with certain low-risk research.
External outside the body.
Extravasate to leak outside of a blood vessel.
Fibrillation
irregular beat of the heart or other muscle.
Fibrous having many fibers, such as scar tissue.
FDA U S food and drug administration, the branch
of federal government which approves new drugs.
General
Anesthesia pain prevention by induction of drugged
sleep, as in surgery.
Gestational pertaining to pregnancy.
Hematocrit
amount of red blood cells in the blood.
Hematoma a bruise, a black and blue mark.
Hemodynamic related to blood flow.
Hemolysis breakdown in red blood cells.
Heparin Lock needle placed in the arm with blood
thinner to keep the blood from clotting inside the needle
or tubing.
Hepatoma cancer or tumor of the liver.
Heritable Disease a disease which can be
transmitted to one's offspring resulting in damage to
future children.
Histopathologic pertaining to the disease status
of body tissues or cells.
Holter Monitor a portable machine for recording
heart beats.
Human Participant (subject) Under DHHS regulations a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction, or (2) identifiable private information. Under FDA regulations an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient. For research involving medical devices a human subject is also an individual on whose specimen an investigational device is used.
Hypercalcemia high blood calcium level.
Hyperkalemia high blood potassium level.
Hypernatremia high blood sodium level.
Hypertension high blood pressure.
Hypocalcemia low blood calcium level.
Hypokalemia low blood potassium level.
Hyponatrenia
low blood sodium level.
Hypotension low blood pressure.
Hypoxia low oxygen level in the blood.
Iatrogenic
caused by a physician or by treatment.
IDE investigational device exemption, the license
to test an unapproved new medical device.
Idiopathic of unknown cause.
Immunoglobulin a combination of antibodies from
proteins in the blood.
Immunosuppressive drug which suppresses the body's
immune response used in transplantation and diseases
caused by disordered immunity.
Immunotherapy giving of drugs to help the body's
immune (protective) system; usually used to destroy
cancer cells.
Impaired function abnormal function.
Implanted placed in the body.
IND investigational new drug; the license to test
an unapproved new drug.
Induction Phase beginning phase or stage of a
treatment.
Induration hardening.
Indwelling remaining in a given location, such as
a catheter.
Infarct death of tissue because of lack of blood
supply.
Infectious Disease disease which is transmitted
from one person to next.
Inflammation swelling which is generally painful,
red, and warm.
Infusion introduction of a substance into the
body, usually into the blood.
Ingestion eating; taking by mouth.
Interferon agent which acts against viruses;
antiviral agent.
Intermittent occurring (regularly or irregularly)
between two time points; alternately ceasing and
beginning.
Internal within the body.
Interior inside of the body.
Intramuscular into the muscle; within the muscle.
Intraperitoneal into the abdominal cavity.
Intrathecal into the spinal fluid.
Intravenous (IV) into (within) a vein.
Intravesical in the bladder.
Intubate the placement of a tube into the airway.
Invasive Procedure puncture, opening or cutting of
the skin.
Investigational New drug (IND) a new drug
which has not yet been approved by the FDA.
Investigational Method a treatment method
which has not been proven to be beneficial or has not
been accepted as standard care.
Ischemia Procedure decreased oxygen in a
tissue (usually because of decreased blood flow).
Laporatony
a procedure in which an incision is made in the abdominal
wall to enable a physician to look at the organs.
Lethargy sleepiness.
Leukopenia low white blood cell count.
Lipid fat.
Lipid profile (panel) fat and cholesterol levels
in the blood.
Local Anesthesia creation of insensitivity to pain
in a small local area of the body.
Localized restricted to one area; limited to one
area (of the body).
Lumen cavity of an organ or tube (e g Inside of
blood vessel).
Lymphangiography an x-ray of the lymph nodes or
tissues after injection of dye in lymph vessels (e g in
feet).
Lymphocyte a type of white blood cell important in
the body's defense against infection.
Lymphoma a cancer of the lymph nodes (or tissues).
Malaise
a vague feeling of bodily discomfort, feeling bad.
Malfunction condition in which something is not
functioning properly.
Malignancy cancer or other progressively enlarging
and spreading tumor, fatal if not successfully treated.
Medulloblastoma type of brain tumor.
Metronidazole a drug used to treat infections
caused by parasites or other causes of anaerobic
infections.
Metabolize process of breaking down substances in
the cells.
Metastasis spread of cancer cells from one part of
body to another.
MI myocardial infarction, heart attack.
Minimal slight.
Minimize reduce.
Monitor check on; keep track of; watch carefully.
Mobility ease of movement; ability to move around.
Morbidity undesired result or complication;
serious disease.
Mortality death or death rate.
Motility the ability to move.
MRI magnetic resonance imaging, body pictures
created using magnetic rather than x-ray energy.
Myalgia muscles aches.
Mucosa, Mucous Membrane moist lining
of digestive, respiratory, reproductive, and urinary
tracts.
Myocardial pertaining to the (muscle of the)
heart.
M. Infarction heart attack; death of heart muscle.
Nasogastric
Tube tube from the nose to the stomach.
NCI National Cancer Institute.
Necrosis death of tissue.
Neoplasia tumor, may be non-cancerous or
cancerous.
Neuroblastoma a cancer of nerve tissue.
Neurological pertaining to the nervous system.
Neutropenia decrease in the main part of the white
blood cells.
NIH National Institutes of Health.
Non-Invasive not breaking, cutting or entering the
skin.
Nosocomial Pneumonia pneumonia acquired in the
hospital.
Occlusion
closing; obstruction.
Oncology the study of tumors or cancer.
Ophthalmic pertaining to the eye.
Optimal best, most favorable or desirable.
OPRR Office of Protection from Research Risks of
the NIH, oversees IRBs and related matters.
Oral Administration given by mouth.
Orthopedic pertaining to the bones.
Osteopetrosis rare bone disorder characterized by
dense bone.
Osteoporosis bone disorder characterized by loss
of bone leading to increased risk of fracture.
Ovaries female sex glands; female organs which
release eggs.
Parenteral
administration by injection.
Patency condition of being open.
Pathogenesis the initial cause of a disease.
Percutaneous Perforation through the skin
puncture, tear or hole.
Peripheral not central.
Per OS (PO) by mouth.
Pharmacokinetics study of the way the body
absorbs, distributes and gets rid of a drug.
Phase I initial study of a new drug in humans to
determine limits of tolerance.
Phase II second phase of study of a new drug
intended to obtain initial information.
Phase III large scale trial to confirm and expand
information on safety and usefulness of a new drug.
Phlebitis irritation or inflammation of a vein.
Placebo an inactive substance which may resemble
an active agent but has no medical value.
Placebo Effect symptom or change of condition seen
when a placebo is given; not attributable to an active
drug agent.
Platelets small particles in the blood that help
with blood clotting.
Potential possible.
Potentiate increase or multiply the effect of a
drug or toxin by administration of another drug or toxin
at the same time.
Potentiator an agent that helps another agent work
better.
Prenatal before birth.
Prophylaxis a drug given to prevent disease or
infection.
Prosthesis artificial limbs, such as arms and
legs.
PRN as needed.
Prognosis outlook, probable outcomes.
Prone lying on the stomach.
Prospective Study study following patients forward
in time.
Protocol plan of study.
Proximal closer to the center of the body, away
from the end.
Pulmonary pertaining to the lungs.
QD
every day; daily.
QID four times a day.
Radiation
Therapy x-ray or cobalt treatment.
Random by chance.
Randomization assignment of treatment group by
chance, similar to tossing a coin (when there are two
treatment choices).
RBC red blood cell.
Research Under DHHS regulations a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of 45 CFR 46, even if they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. Under FDA regulations any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under section 505(i) or 520(g) of the Food, Drug, and Cosmetics Act, or need not meet the requirements for prior submission to the FDA under these sections of the Food, Drug, and Cosmetics Act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. For research involving drugs, FDA defines an “experiment” as any use of a drug except for the use of a marketed drug in the course of medical practice.
Recombinant formation of new combinations of
genes.
Reconstitution putting back together the original
parts or elements.
Recur happen again.
Refractory not responding to treatment.
Regeneration regrowth of a structure or of lost
tissue.
Regimen pattern of administering treatment.
Relapse the return or reappearance of a disease.
Remission disappearance of evidence of cancer or
other disease.
Renal pertaining to the kidneys.
Replicable capable of being duplicated.
Resect remove or cut out (surgically).
Retrospective Study study looking back over past
experience.
Sarcoma
a type of cancer.
Sedative a drug to calm or make less anxious.
Seminoma a type of testes cancer.
Sequentially in a row.
Software computer program.
Somnolence sleepiness.
Spirometer an instrument to measure the amount of
air taken into and exhaled from the lungs.
Standard of Care treatment plan which the majority
of the medical community would accept as appropriate.
Staging a determination of the extent of the
disease.
Stenosis narrowing of a duct, tube, or one of the
heart valves.
Stomatitis mouth sores; inflammation of the mouth.
Stratify arrange in groups for analysis of results
(e g , Stratify by age, sex, etc).
Stupor stunned state in which it is difficult to
get a response or the attention of the subject.
Subclavian under the collarbone.
Subcutaneous under the skin.
Supine lying on the back.
Supportive care general medical care aimed at
symptoms, not intended to improve or cure underlying
disease.
Symptomatic having symptoms.
Syndrome a condition characterized by a set of
symptoms.
Systolic top number in blood pressure; pertaining
to contraction phase of heart beat.
Teratogenic
capable of causing malformations in unborn fetuses.
Testes male sex glands; male organs which produce
sperm.
Thrombosis blood clotting within blood vessels.
TID three times a day.
Titration gradual alteration of drug dose to
determine desired effect or most beneficial strength of
drug.
T-lymphocytes type of white blood cells involved
in immune reactions.
Topical surface; on the skin.
Topical Anesthetic applied to certain area of the
skin to reduce pain to specific (limited) area to which
applied.
Toxicity side effects or undesirable effects of a
drug.
Transdermal through the skin.
Transiently temporarily.
Trauma injury; wound.
Treadmill walking machine often used to determine
heart function.
Uptake
absorption and incorporation of a substance by living
tissue; absorb and incorporate a substance, taking in of
a substance by living tissue.
Valvuloplasty
plastic repair of a valve, especially of the heart.
Varices enlarged veins, usually in legs or lining
of tube between mouth and stomach.
Vasospasm narrowing of blood vessels due to spasm
of vessel walls.
Vector a carrier, usually an insect, that carries
and transmits disease-causing microorganisms.
Venipuncture entering vein with a needle,
generally through the skin.
Vertical Transmission spread of disease.
WBC
white blood cell.
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