| A |
| abdomen |
belly |
| abdominal |
having to do with the belly |
| abdominal cavity |
space in the belly where the stomach, intestines, kidney, liver, gall bladder, pancreas, spleen, and ureters are found |
| abdominocentesis |
use of needle or tube to drain fluid from the belly |
| abdominoperineal resection |
surgery to remove the middle and end of the large intestine |
| abdominoplasty |
surgery to fix the stomach |
| abduction |
movement away from the middle of the body |
| abortion |
the premature end of a pregnancy |
| abrasion |
area where skin or other tissue is scraped away |
| abruptio placentae |
premature separation of the placenta from the mother |
| abscess |
swelling filled with pus |
| absorption |
the way a drug or other substance enters the body
the route and rate that a compound gets into the system (bloodstream) |
| acapnia |
decreased carbon dioxide in the blood |
| acetabulum |
pocket in the hip bone that holds the top of the upper leg bone |
| acidosis |
increase of acid in the blood |
| acne |
pimples |
| acoumeter |
tool used to measure hearing |
| acoustic neuroma |
growth in the ear canal |
| acquired immunodeficiency syndrome (AIDS) |
contagious illness that results in decreased ability of the body to protect itself from other illnesses |
| acromegaly |
a disease of adults in which the body makes too much growth hormone |
| actinic keratosis |
skin disease (bumps) caused by extreme overexposure to the sun |
| activated partial thromboplastin time |
a test of blood clotting time used to measure the ability of the blood to clot |
| active ingredient |
The pharmacolgically active part of any medication. Many pharmaceutical products contain inactive ingredients that create the formulation. |
| acute |
lasting a short time but often causing a serious problem |
| Addison's disease |
serious disorder in which there is decreased cortisol and aldosterone in the body, resulting in weakness, low blood pressure, and other serious problems |
| adduction |
movement toward the middle of the body |
| adenohypophysis |
gland in the brain that makes many hormones that control body functions |
| adenoidectomy |
surgery to take out the adenoids |
| adenoiditis |
inflammation of the adenoids |
| adenoids |
infection-fighting glands in the back of the throat |
| adenomyosis |
a growth of muscle in the uterus |
| adenotome |
tool used to remove adenoids |
| adhesion |
tissue stuck together |
| adipose |
having to do with fat |
| ADME |
Absorption, Distribution, Metabolism and Excretion. This describes the four stages that a pharmaceutical product would go through when administered to a human. |
| administer |
give |
| adrenal gland |
a gland found over each kidney |
| adrenalectomy |
surgery to remove an adrenal gland |
| adrenaline |
hormone made by the adrenal glands that speeds up body organs and helps the body deal with stress |
| adrenalitis |
inflammation of one or both adrenal glands |
| adrenocortical hormone |
any of the hormones made by the outer layer of the adrenal glands |
| adrenocorticohyperplasia |
increased growth of one or both adrenal glands |
| adrenocorticotropic hormone |
hormone made by the brain that activates the adrenal glands |
| adrenomegaly |
increase in size of one or both adrenal glands |
| adrenopathy |
disease of one or both adrenal glands |
| Advanced Technology Medicinal Product (ATMP) |
a gene therapy medicinal product
a somatic cell therapy medicinal product
a tissue engineered product. |
| adverse |
harmful, bad |
| Adverse Drug Reaction (ADR) |
In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.
The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out.
Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function |
| Adverse Event (AE) |
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| aerosol |
drug or substance made as a mist to be breathed in |
| Aetiology |
The factors involved in causing a disease. |
| afferent |
going toward the center area |
| afterbirth |
material that provides nutrition for the unborn baby and comes out after the baby is born (placenta) |
| airway |
tube through which air passes to enter and leave the lungs |
| alanine aminotransferase (ALT) |
substance in blood that is measured to check for liver disease |
| albino |
white; lacking pigment (lacking color) |
| albuminuria |
protein in the urine |
| alcohol |
drug found in whisky, wine, and beer that slows down the central nervous system |
| aldosterone |
hormone made by the adrenal glands that controls the amount of mineral salts in the body |
| Algorithm |
A procedure to assist the structured achievement of an outcome that involves a series of alternative decisions |
| allergy |
oversensitivity to a substance |
| alopecia |
baldness |
| alpha-fetoprotein |
substance in blood that is measured to check for liver cancer, testicular cancer , and spina bifida |
| ALS |
see amyotrophic lateral aclerosis (ALS) |
| Alzheimer's disease |
disorder that causes mental confusion |
| amenorrhea |
when a woman has no menstrual period |
| amniocentesis |
removal of some of the waters from around an unborn baby for laboratory testing |
| amniochorial |
having to do with the tissues that surround the unborn baby |
| amniography |
x-ray of the uterus (womb) and unborn baby taken after putting a dye into the bag of waters |
| amnion |
tissue that covers the unborn baby |
| amnionitis |
inflammation of the amnion |
| amniorrhea |
leaking of waters from around the unborn baby |
| amniorrhexis |
breaking of the amnion |
| amnioscope |
tool inserted through the cervix to look at the amniotic fluid and the unborn baby |
| amniotic fluid |
waters around the unborn baby |
| amniotic sac |
bag of tissue that surrounds the unborn baby |
| amniotomy |
rupture of the membranes (breaking of the tissues around the unborn baby) - done to start labor |
| amphetamines |
drugs that speed up metabolism and decrease appetite ("speed") |
| amyotrophic lateral sclerosis (ALS) |
a disease of the nerves that causes weakness, also known as Lou Gehrig's Disease |
| anal |
having to do with the anus |
| analgesic |
drug used to control pain
Drugs to relieve or reduce pain |
| Analysis of Variance (ANOVA) |
A statistical technique to determine whether the mean values of different treatment groups are the same or different. |
| anaphylactic shock |
serious allergic reation to a substance (e.g., food, drug)
Severe generalised form of anaphylaxis which may lead to a sudden attack of wheezing, collapse, cardiac arrest and may lead to death |
| Anaphylaxis |
Severe allergic reaction |
| androgen |
male sex hormone |
| anemia |
decreased number of red blood cells |
| anesthesia |
loss of sensation or feeling |
| anesthetic |
drug that is used to produce loss of pain sensation |
| aneurysm |
area where an artery is swollen like a sack because the wall of the artery is weak |
| aneurysmectomy |
surgery to take out an aneurysm |
| angina pectoris |
chest pain due to decreased oxygen being supplied to the heart |
| angiocarditis |
inflammation of the heart and the blood vessels entering the heart |
| angioma |
growth made up of blood vessels or lymph vessels |
| angioplasty |
surgery to open up a narrow blood vessel |
| angiorrhaphy |
stitching a blood vessel |
| angioplasm |
cramp in the blood vessels |
| angiostenosis |
narrowing of the inside of a blood vessel |
| angled |
bent, not straight |
| ankylosing spondylitis |
inflammation of the spine causing pain and stiffness |
| ankylosis |
joint stiffness |
| anoplasty |
surgery to fix the anus |
| anorexia |
no appetite for food |
| anorexia nervosa |
mental disorder in which fear of getting fat results in starvation and weight loss |
| anoxia |
no oxygen |
| antacid |
drug used to decrease acid in the stomach (e.g., Tums, Rolaids) |
| antecubital. |
in front of the elbow |
| antepartum |
before childbirth |
| anterior |
having to do with the front of the body |
| anterior and posterior colporrhaphy |
surgery to fix weak muscles in the pelvic area |
| anterior lobe |
front part of an organ |
| anterior lobe of the pituitary |
part of the pituitary gland that discharges many hormones |
| antianginal |
drug used to relieve chest pain |
| antiarrhythmic |
drug used to resote the natural rhythm of the heart |
| antibiotic |
drug used to stop or slow down the growth of germs |
| antibody |
type of protein that helps protect the body against foreign matter, such as baccteria and viruses |
| anticoagulant |
drug used to stop blood from clotting |
| anticonvulsant |
drug used to stop seizures |
| antidiarrheal |
drug used to stop diarrhea |
| antidiuretic hormone |
hormone made by the pituitary gland that helps the kidneys keep water in the body by decreasing urine formation |
| antidote |
substance used to treat allergic reactions |
| antiemetic |
drug used to stop vomiting |
| antihistamine |
drug used to treat allergic reaction |
| antinauseant |
drug used to stop nausea and vomiting |
| antipruitic |
drug used to stop itching |
| antiseptic |
substance used to stop or slow down the growth of germs |
| antrectomy |
surgery to remove the lower part of the stomach |
| antrum |
lower part of the stomach |
| anuria |
no urine being made |
| anus |
ring of muscle that keeps the opening at the end of the digestive tract closed |
| aorta |
biggest artery in the body |
| aortic stenosis |
narrowing of the aorta where it comes out of the heart |
| aortogram |
x-ray of the aorta |
| apepsia |
without digestion |
| aphagia |
not able to swollow |
| aphasia |
not able to speak or write and not able to understand spoken or written words |
| apnea |
stopping of breathing |
| aponeurorrhaphy |
stitiching of an aponeurosis |
| aponeurosis |
strong tissue that joins muscle to bone |
| appendectomy |
surgery to remove the appendix |
| appendicitis |
inflammation of the appendix |
| appendix |
|
| Applicable Regulatory Requirement(s) |
Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. |
| approximately |
nearly, about |
| aqueous humor |
liquid found in the front of the cavity of the eye |
| arachnoid |
middle layer of the meninges |
| Area Under Curve (AUC) |
Plot of concentration of a drug against time. Used as a method of comparing bioavailability of different products |
| areola |
dark-colored skin around the breast nipple |
| arrhythmia |
uneven heart beat |
| arteriogram |
x-ray using a dye to outline an artery |
| arterioles |
small branches of arteries |
| arteriorrhexis |
breaking of an artery |
| arteriorsclerosis |
hardening of the artery |
| artery |
the type of blood vessel that carries blood and oxygen from the heart to the rest of the body |
arthralgia |
pain in a joint |
| arthritis |
inflammation of one or more joints |
| arthrocentesis |
use of a needle to remove fluid from a joint |
| arthroclasia |
surgery to free up a joint that it is stiff so it cannot move |
| arthrodesia |
surgery to fasten a joint so it cannot move |
| arthrogram |
x-ray of a joint |
| arthroplasty |
surgery to fix a joint |
| arthrosclerosis |
stiffening of the joints |
| arthroscope |
tool used to look into a joint |
| arthrotomy |
surgery to cut into a joint |
| articular cartilage |
smooth tissue that covers the bones inside a joint |
| artificial insemination |
use of a tool to put sperm into the vagina for the purpose of beginning pregnancy |
| ascites |
fluid in the belly |
| aspartate aminotransferase (AST) |
substance in blood that is measured to detect liver disease |
| aspermia |
no sperm |
| asphyxia |
suffocation |
| aspirate |
removing a substance using suction |
| asthma |
breathing disorder in which there is a wheezing and difficulty breathing |
| astigmatism |
flaw in the curve of the eye |
| ataxia |
uncontrolled muscle movement; incoordination |
| atelectasis |
collapse of a lung |
| atherosclerosis |
hardening of the arteries |
| atraumatic |
not damaging to tissue |
| atrioventricular defect |
hole in the heart present at birth |
| atrophy |
wasting away, or decrease in size, of a body organ |
| audiogram |
report of a hearing test |
| audiologist |
doctor who studies hearing |
| audiology |
the study of hearing |
| audiometer |
tool used to measure hearing |
| audiometry |
measurement of hearing |
| Audit |
A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). |
| Audit Certificate |
A declaration of confirmation by the auditor that an audit has taken place |
| Audit Report |
A written evaluation by the sponsor's auditor of the results of the audit. |
| Audit Trail |
Documentation (paper or electronic) that allows reconstruction of the course of events. |
| aural |
having to do with the ear |
| auricle |
outside flap of the ear |
| auscultation |
use of a stethoscope to listen to sounds inside the body |
| autoimmune disease |
disorder in which a person's immune system attacks parts of his or her own body |
