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Common Clinical Research Terms

adverse eventAn unexpected medical problem that happens during treatment with a drug or other treatment
benefitSomething that is useful or produces a good result or effect.
biomarkerSomething found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Also called molecular marker and signature molecule.
Biospecimens/Tissue samplesSamples collected like blood or removed tissue (including skin, tumor, swabs of the mouth, etc.)
biotherapyA type of treatment that uses substances from living organisms to treat disease.  These substances may occur naturally in the body or may be made in the lab.  In cancer, some biotherapies stimulate or suppress the immune system to help the body fight cancer. 
ChemotherapyTreatment that uses drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 
Clinical TrialA research study on humans designed to answer specific questions
compliance Following a medical treatment or schedule correctly, including taking meds or following a diet
consentTo give permission 
databaseA place where pieces of collected information is organized and stored
diaryA record or log where one records information like when meds were taken, any side effects suffered, etc.
DNADNA is the short term of deoxyribonucleic acid. DNA is in every cell in the body and stores information in the form of a code. This is the code you inherit from your parents and you pass on to your children. 
Eligibility criteriaEach research protocol has guidelines for who can and cannot take part in the study. They may include age, gender, medical history, health status and type of cancer and stage of disease
end of treatment/EOTThe point when study treatment ends.  There still may be follow up visits required.
endocrine therapyTreatment that adds, blocks, or removes hormones
Exclusion criteriaConditions that keep a person from being able to take part in a study
FDAFood and Drug Administration. They are responsible for approving new drugs and devices
geneThe basic physical and functional unit of heredity and made up of DNA. Genes carry the instructions for making proteins, which direct the activities of cells and functions of the body.
geneticsRefers to the study of genes and their roles in inheritance – the way that certain traits or conditions are passed down from one generation to another.
genomicsRefers to the study of all of a person’s genes (the genome), including interactions of those genes with each other and with the person’s environment to better understand complex diseases.
GINAGenetic Information Nondiscrimination Act (GINA), that prohibits health insurance companies and larger employers from treating people unfairly based on their genetics.
HIPAAHealth Insurance Portability and Accountability Act is a federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge.
immunotherapyA form of cancer treatment that uses the power of the body’s own immune system to prevent, control, and get rid of cancer.
Impartial witnessSomeone who is neutral about the trial, who cannot be unfairly influenced by people involved with the trial, and who attends the informed consent process if the subject or their representative cannot read.
Inclusion criteriaConditions that must be present for a person to be able to take part in a study
informed consentA form that gives a summary of the trial, including its purpose, the treatment procedures and schedule, possible risks and benefits, and other treatment options. It also explains your rights as a clinical trial subject. If you decide to enter the trial, you give your official consent by signing the form.
institutionThe place where the research is being done
investigatorStudy doctor
Institutional Review Board/IRBA research ethics board that reviews, approves, and monitors research that involves human subjects. They serve an important role to protect the rights and welfare of human research subjects.
LARLegally Authorized Representative is someone who has the legal right to act or speak on behalf of another person when he or she cannot.
Molecular/Tumor profileTesting that classifies tumors based on genetic make-up to help diagnose and treat cancer. Using a blood test or biopsy, the test examines the DNA of cancer cells, looking for genetic mutations that have been acquired by these cells.
monoclonal antibodyA type of protein made in the laboratory that can bind to substances in the body, including cancer cells.
NCINational Cancer Institute
Novel treatmentSomething new and not like what is already known or used.
participantSomeone who takes part in a clinical trial/research study
Pathology reportDescribes cells and tissues based on what is seen under a microscope by the pathologist and used to make a diagnosis of a disease.
placeboAn inactive substance or other intervention that looks the same as, and is given the same way as, an active drug or treatment being tested. 
precision medicineA form of medicine that uses information about a person’s own genes or proteins to prevent, diagnose, or treat disease. In cancer, precision medicine uses specific information about a person’s tumor to help make a diagnosis, plan treatment, find out how well treatment is working, or make a prognosis.
PRO questionnairesPatient Reported Outcomes are questions about how you rate your health-related quality of life, symptoms such as pain or fatigue, and health service usefulness.  They act as a measure of treatment effectiveness.
ProcedureA series of fixed action followed leading to a result.  Could be scan, surgery, or other test.
PHIProtected health information
radiationThe use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors.
reproductive riskThe possible effect that a study’s experimental drug/device may have on an unborn child, breast-feeding child, and/or the participant’s ability to have or to father future children.
riskThe possibility of something bad happening
RNARNA is the short term for ribonucleic acid. RNA carries DNA’s genetic code to the part of a cell that makes proteins. It also helps control which genes are turned on or off at one point in time. 
screeningA process to make sure you qualify for the trial. This usually involves a series of questions related to your health, the meds you take and possibly your lifestyle.
serious adverse eventAn unexpected medical event that happens during treatment with a drug or other treatment that results in death or becomes life-threatening and requires an inpatient hospital stay, prolongs a hospital stay, causes significant disability, or permanent damage. 
sponsorAn individual, company, institution, or organization that takes on responsibility for opening, managing, and paying for the research.
study drugThe experimental drug that is being given in a clinical trial/research study
SubjectA person who takes part in a clinical trial/research study
surveillanceTo observe and collect information or data to expand the knowledge base 
targeted therapyA type of cancer treatment that uses drugs to precisely identify and attack certain types of cancer cells,
translational researchA term used to describe the process by which the results of research done in the lab are used to develop new ways to diagnose and treat disease.
voluntaryHaving the power to freely choose or give consent
WithdrawalTo remove from study or study treatment