Glossary
510 (K) Device
A medical device that is considered substantially equivalent to a device that was or is being legally marketed
A
Abdomen, Abdominal
Area around stomach, midsection, belly, stomach area; part of the body cavity holds the stomach, intestines, liver, and other organs
Acute
New, recent, sudden
Adjuvant
Additional treatment; treatment that goes along with main treatment to make it work better
Adverse effect
An undesirable and unintended result of therapy or other intervention
Agitation
Upset
Allergic reaction
An allergy to a medication that can cause swelling, rash, itching or trouble breathing
Ambulate
To walk, be able to walk or have the ability to walk
Ameliorate
Make smaller or less, reduce
Analgesia
Pain relief
Anaphylactic Reaction
A severe and sometimes dangerous allergic reaction which may cause swelling, skin rash, itching, problem breathing and/or lower blood pressure
Anemia
Low red blood cell count that may make a person tire easily and short of breath
Anesthetic (local)
A drug used to decrease pain by numbing an area of the body, without putting you to sleep
Anesthetic (general)
A drug used to decrease or eliminate pain by putting you to sleep
Anonymous
Without identification or without including a name
Anorexia
Without appetite; not feeling hungry
Antibody
Substance produced by your body to protect against infection/disease
Arrhythmia
Abnormal heartbeat
Aspiration
Remove fluid with a tube or needle
Assay
Lab test
Assent
Agreement by an individual not competent to give legally valid informed consent to participate in research
Assurance
A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures the institution will institute to maintain compliance
Asymptomatic
Without symptoms, having no symptoms
Barrier method
A type of birth control such as diaphragm, condom, cervical cap or sponge
Benefit
A valued or desired outcome; an advantage
Benign
Not malignant or threatening, usually without serious consequence
Biologic
Any therapeutic serum, toxin, anti-toxin or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries
Bolus
A dose of medicine given at once or over a short period of time
Bone marrow suppression
Decreased growth of blood cells
Bracycardia
Slow heartbeat
Capacity (to make decisions)
The ability of an individual to understand the choices presented, to appreciate the implications of choosing one alternative or another, and to make and communicate a decision
Carcinogenic
Capable of causing cancer
Carcinoma
A type of cancer
Cardiac
Heart
Case Controlled Study
A study comparing persons with a given condition or disease (the cases) and persons without the condition or disease
Catheter
A tube placed in the body to remove or introduce fluids into the body; a tube that moves liquids in or out of the blood; a plastic tube placed in a vein or under the skin to withdraw or introduce fluids in the body
Central nervous system
The brain and spinal cord
Central venous catheter
A plastic tube inserted in a vein under the skin of the chest to remove or introduce fluids into the body
Cerebral
The brain, of the brain
Cessation
To stop doing something
CHD
Coronary heart disease, heart disease
Chemotherapy
Drug treatment of a disease, usually cancer
Chronic
Continuing for a long time
Clinical Status
Current state of health
Clinical Trial
A controlled study involving human subjects, designed to determine the safety and effectiveness of a drug, biologic, device or other treatment or behavioral intervention; an experiment with human subjects
Coercive Cognitively Impaired
Having either a psychiatric disorder or a development disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished.
Compensation
Payment or medical care provided to subjects injured in research. (Does not refer to payment for participation in research.)
Competence
Technically, a legal term, used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice.
Confidential
Information that will not be divulged to others without permission
Congenital
Problem that you are born with
Conjunctivitis
Red, itchy eyes; eye infection
Consent
Approval or acceptance of something done or proposed by another
Consequences
Result or effects
Contraindicated
Should not be used
Control Subjects
Subjects used for comparison who are not given a treatment under study or who do not have a given condition, background or risk factor that is the object of the study
Controlled Study
Research that involves at least two groups: one that receives the intervention being evaluated, and the other that receives either a placebo or another intervention. Sometimes the study also is described as "blind" or "masked"
Conventional Therapy
Standard treatment
Coronary
The blood vessels that are connected to the heart
CT (CAT) Scan
computerized series of x-rays
Culture
Test for infection or organisms that could cause infection; to take a sample of blood, fluid, or tissue to see if bacteria or viruses are found in it
Cutaneous
Relating to the skin
DHHS
U.S. Department of Health and Human Services
Data
Factual information (as measurements or statistics) used as a basis for reasoning, discussion, or calculation
Debriefing
Giving subjects previously undisclosed information about the research project following completion of their participation in research
Dehydration
Not enough fluids
Dermatologic
Pertaining to the skin
Diastolic
The lower number in a blood pressure reading
Dilation
Expansion or stretching
Discomfort
Pain, uncomfortable feeling
Disseminated
Widely spread
Distal
Toward the end, away from the center of the body
Distend
Stretch, expand, bloat
Diuretic
Medicine that makes you urinate, sometimes called a "water pill"
Double-blind
Neither the subject nor physician can know what is being given
Drug
Any chemical compound that may be used or administered to humans
Dysfunction
Doesn't work properly
Dysplasia
Abnormal cells
Echocardiogram
Sound wave test of the heart
Edema
Increased fluid in the tissues; swelling; puffiness
Efficacy
Effectiveness; how well something works
Electrocardiogram (EKG)
A heart test; a tracing of heartbeat or heart rhythm
Embryo
Early stages of a developing organism (i.e., from conception to the eighth week of pregnancy
Emesis
Vomiting
Endoscopic
Examination of the inside of the body with a lighted tube
Epidural
A type of local anesthesia to decrease or eliminate pain
Eradicate
Get rid of
Erythrocyte
A type of red blood cell
Ethnographic Research
Ethnographic research, also called fieldwork, involves observation of an interaction with the persons or group being studied in the group's own environment, often for long period of time
Expedited Review
Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB
Failed Therapy
Treatment that was not effective for a patient
False Negative
When a test wrongly shows an effect or condition to be absent
False Positive
When a test wrongly shows an effect or condition to be present
FDA
Food and Drug Administration
Fetal Material
The placenta, amniotic fluid, fetal membranes and umbilical cord
Fetus
The product of conception from the time of implantation until delivery (i.e., generally refers to later phases of development)
Fibrillation
Irregular heartbeat
Fibrous
Like scar tissue
Fieldwork
Behavioral, social, or anthropological research involving the study or persons or groups in their own environment and without manipulation for research purposes
Gastrointestinal
Stomach and intestines
Gene Therapy
The treatment of genetic disease accomplished by altering the genetic structure of either somatic (non-reproductive) or germ line (reproductive) cells
Genetic Screening
Tests to identify persons who have inherited predisposition to a certain phenotype or who are at risk of producing offspring with inherited diseases or disorders
Granulocyte
A type of white blood cells
Guardian
An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care. A guardian may also be appointed by a court to make decisions for an incompetent adult
Hematocrit
Number of red blood cells
Hematoma
A bruise; a black and blue mark
Holter monitor
Portable machine for recording heartbeats
Hormonal therapy
Treatment with hormones
Human In Vitro Fertilization
Any fertilization involving human sperm and ova that occurs outside the human body
Human Subject
Individuals who physiologic or behavior characteristics and responses are the object of study in a research project
Hypertension
High blood pressure
Hypotension
Low blood pressure
Hypoxia
Low oxygen level in the blood
Immunosuppressive
A drug or therapy that reduces the body's ability to fight infection or helps prevent rejection of a transplanted organ
In Vitro
Literally, "in glass" or "test tube"; used to refer to processes that are carried out outside the living body, usually in the laboratory
In Vivo
Literally, "in the living body"; processes carried out in the living body rather than in a laboratory
Incidence
Number of times something happens
Infarct
Death of tissue due to loss of blood flow
Inflammation
Swelling which is usually painful, red or warm
Informed Consent
A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence
Infusion
Putting a substance into the body, usually into the blood
Institution (1)
Any public or private entity or agency (including federal, state, and local agencies)
Institution (2)
A residential facility that provides food, shelter, and professional services (including treatment, skilled nursing, intermediate or long-term care, and custodial or residential care).
Institutional Review Board (IRB)
A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research
Institutionalized
Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home)
Institutionalized Cognitively Impaired
Persons who are Confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled
Intravenous
To put something through a vein
Intubate
The placement of a tube into the airway to help a person breathe
Investigational Device Exemptions (IDE)
Exemptions from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations
Investigational New Drug or Device
A drug or device permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing
Investigator
In clinical trials, an individual who actually conducts an investigation
IRB
Institutional Review Board (see above)
Ischemia
Low oxygen in a tissue, usually because of decreased blood flow
Lactating
Producing milk
Laparotomy
A procedure where a small cut is made in the stomach area, so a physician can look at the organs
Legally Authorized Representative
A legally authorized representative as an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject?s participation in the procedure(s) involved in the research.
Lethargy
Lack of energy; sluggish
Longitudinal Study
A study designed to follow subjects forward through time
Lumen
Inside a blood vessel
Lymphocyte
A type of white blood cell important for defense against infections
Magnetic Resonance Imaging (MRI)
Pictures of the body created using magnetic rather than x-ray pictures
Malaise
Feeling bad; a feeling of bodily discomfort, feeling sick
Malignancy
Cancer which usually spreads and may be fatal if not successfully treated
Masked/Blinded Study Design
Study designs comparing two or more interventions in which either the investigators, the subjects, or some combination thereof do not know the treatment group assignments of individual subjects
Mature Minor
Someone who has not reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes
Medical Device
A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body
Metastasis
Spread of cancer cells from one part of the body to another
Minimal Risk
When the probability and magnitude of harm or discomfort anticipated in the proposed research is not greater (in and of themselves) than those ordinarily encountered in daily life
Monitor
Check on, keep track of, watch carefully
Monoclonal antibody
A type of antibody made outside your body to protect against your particular disease
Morbidity
Sickness/illness; undesired result or complication
Mortality
Death or death rate
Motility
The ability to move
MRI
Magnetic Resonance Imaging (see above)
Murine
Obtained from mice
Myalgia
Muscle aches
Myocardial infarction
Heart attack
Nasogastric tube
A tube from the nose to the stomach
Necrosis
Death of tissue
Neonate
A newborn infant, especially one less than four weeks old
Neoplasia
New growth of cells that my be cancerous or non-cancerous
Neural
Brain or nerves
Neutropenia
Decrease in a type of white blood cells
New Drug Application
Request for FDA approval to market a new drug
NIH
National Institutes of Health
Non-invasive
Not breaking, cutting or entering the skin
Non-significant Risk Device
An investigational medical device that does not present significant risk to the patient or research subject, taking into account all of the risks inherent in the study
Obviate
To prevent or eliminate
Occlusion
Closing, obstruction, blockage
Occult blood test
Testing a stool sample for small amounts of blood that you canâ??t see
Oncology
The study of tumors or cancer
OPRS
Office for the Protection of Research Subjects
Open Design
An experimental design in which both the investigator(s) and the subjects know the treatment group(s) to which subjects are assigned
Ophthalmic
Pertaining to the eye
Orthopedic
Pertaining to bones
Osteoporosis
Bone disorder resulting in thinning of bones causing them to break easily
Ovaries
Female sex glands that release the egg cells
Pancytopenia
Low number of all the blood cells
Paralysis
Permanent or temporary loss of sensation or voluntary motion
Parathesia
Numbness, prickling or tingling feeling
Percutaneous
Through the skin
Perforation
Puncture, tear or hole
Phase 1,2,3,4 Drug Trials
Different stages of testing drugs in humans, from first application in humans (Phase 1) through limited and broad clinical tests (Phase 3), to post-marketing studies (Phase 4)
Phlebitis
Irritation or inflammation of a vein
PHS
Public Health Service
Placebo
A chemically inert/inactive substance like a sugar pill
Platelets
Blood cells that help the blood clot normally
Post
After
Preclinical Investigations
Laboratory and animal studies designed to test the mechanisms, safety, and efficacy of an intervention prior to its application to humans
Pregnancy
The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e., has been delivered)
Premarket Approval
Process of scientific and regulatory review by the FDA to ensure the safety and effectiveness of Class III devices
Prenatal
Before birth
Principal Investigator
The scientist or scholar with primary responsibility for the design and conduct of a research project
Prisoner
An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, trial or sentencing; and (3) detained in other facilities
Privacy
Control over the extent, timing and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others
Probability
Chance
Proband
Subject in a genetic study
Prognosis
Outlook, probably outcomes
Prophylaxis
A drug given to prevent disease or infection
Prosthesis
Artificial body parts, such as arms, legs, hips
Protocol
The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data
Proximal
Near; close to the center of the body;
Pruritus
Itching
Psychosis
Serious mental disorder
Pulmonary
Pertaining to the lungs
QID
Four times a day
Radiotherapy
Treatment with radiation
Random, Random Assignment, Randomization
Assignment of subjects to different treatments, interventions, or conditions according to chance rather than systematically. Random assignment of subjects to conditions is an essential element of experimental research because it makes more likely the probability that differences observed between subject groups are the result of the experimental intervention.
Recur
Happening again or come back
Refractory
Not responding to treatment
Regimen
Pattern of giving treatment, schedule of when you will get medicine
Relapse
Return or reappearance of a disease
Remission
Disappearance of evidence of cancer or other disease
Remuneration
Payment for participation in research
Renal
Pertaining to the kidney
Research
A systematic investigation designed to develop or contribute to generalizable knowledge
Resect
Remove or cut out surgically
Respiratory failure
Lung failure; stop breathing
Risk
The probability of harm or injury occurring as a result of participation in a research study
SAMHSA
Substance Abuse and Mental Health Services Administration; includes the Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment and the Center on Mental Health Services
Significant Risk Device
An investigational medical device that presents a potential for serious risk to the health, safety, or welfare of the subject and are:
- Intended for use as an implant; or
- Purported or represented to be of use in supporting or sustaining human life; or
- Intended for a use that is of substantial important in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health; or
- A potential source of serious risk to the health, safety, or welfare of human subjects
Single-Masked Design
Typically, a study design in which the investigator, but not the subject, knows the identity of the treatment assignment. Occasionally the subject, but not the investigator, knows the assignment. Sometimes called "single-blind design."
Somnolence
Sleepy
Sponsor (of a Drug Trial)
A person or entity that initiates a clinical investigation of a drug â?? usually the drug manufacturer or research institution that developed the drug. The sponsor does not actually conduct the investigation, but rather distributes the new drug to investigators and physicians for clinical trials.
Sponsor-Investigator
An individual who both initiates and actually conducts, alone or with others, a clinical investigation. Corporations, agencies or other institutions do not qualify as sponsor-investigators.
Staging
Figure out the extent of the disease
Stenosis
Narrowing of a duct, tube, or blood vessel
Stratify
Arrange in groups by age, sex, etc., for analysis
Subcutaneous
Under the skin
Subsequent
Another, next
Supine
Lying on the back
Symptomatic
Having symptoms
Syndrome
A condition with a certain set of symptoms
Systolic
The top number in blood pressure
Tachycardia
Fast heart beat
Taper
decrease, reduce
Therapy
Treatment
Thrombosis
A blood clot in a blood vessel
Tinnitus
Ringing in the ears
Titration
Gradual increase or decrease of a drug dose until finding the dose that works best
Topical
Put on the skin, like a cream or lotion
Toxicity
Harm; problem; poisoning; unwanted side effect
Transdermal
Through the skin
Transient
Short-term; brief
Trauma
Injury; wound
Trial
Study
Uptake
Taking a substance into the body and the cells
Uremia
Kidney failure
Varices
Enlarged veins, usually in the legs or lining of the tube connecting the mouth to the stomach
Vasodilation
Widening of the blood vessels
Vasospasm
Narrowing of the blood vessels due to a spasm of the vessel walls
Vehicle preparation
A cream or liquid used to deliver medicine
Venipuncture
Placing a needle in a vein to take blood
Vertigo
Dizziness; light-headedness
Via
By
Viable Infant
When referring to a delivered or expelled fetus, the term "viable infant" means likely to survive to the point of sustaining life independently, given the benefit of available medical therapy. This judgment is made by a physician.
Voluntary
Free of coercion, duress or undue inducement
Waive
Give up; do without