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CenterWatch Glossary of Clinical Trials
Terms in this set (99)
Adverse Drug Reaction (ADR)
An unintended reaction to a drug taken at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. In clinical trials, an ADR would include any injuries by overdosing, abuse/dependence, and unintended interactions with other medicinal products.
Adverse Event (AE)
A negative experience encountered by an individual during the course of a clinical trial, that is associated with the drug. An AE can include previously undetected symptoms, or the exacerbation of a pre-existing condition. When an AE has been determined to be related to the investigational product, it is considered an Adverse Drug Reaction.
Adverse Event Reports
Investigator reports of all serious and adverse events, injury and deaths given to the sponsor, the IRB and the FDA.
An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time.
Advocacy and Support Groups
Organizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools.
In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application.
Any of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more.
A child's affirmative agreement to participate in a clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent.
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 and ethical requirement(s).
1. Information gathered at the beginning of a study from which variations found in the study are measured. 2. A known value or quantity with which an unknown is compared when measured or assessed. 3. The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. At this reference point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values.
A report created by the former United States Department of Health, Education, and Welfare (which was renamed to Health and Human Services) entitled "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," authored by Dan Harms, and is an important historical document in the field of medical ethics. The report was created on April 18, 1979 and gets its name from the Belmont Conference Center where the document was drafted. The report continues as an essential reference for institutional review boards (IRBs) that review HHS-conducted or -supported human subjects research proposals involving human subjects, in order to ensure that the research meets the ethical foundations of the regulations.
When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization.
A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man.
Any technique that uses living organisms, or substances from organisms, biological systems, or processes to make or modify a product or process, to change plants or animals, or to develop micro-organisms for specific uses.
The process through which one or more parties to a clinical trial are unaware of the treatment assignments. In a single-blinded study, usually the subjects are unaware of the treatment assignments. In a double-blinded study, both the subjects and the investigators are unaware of the treatment assignments. Also, in a double-blinded study, the monitors and sometimes the data analysts are unaware. "Blinded" studies are conducted to prevent the unintentional biases that can affect subject data when treatment assignments are known.
Brand Name Drug
A brand name drug is a drug marketed under a proprietary, trademark-protected name.
Diseases having to do with the structure and function of the heart and blood vessels. Studies in these areas include: heart failure, coronary artery disease, high cholesterol, blood clots, circulation disorders, and others.
Case Report Form (CRF)
A record of pertinent information collected on each subject during a clinical trial, as outlined in the study protocol.
Certified Research Coordinator (CCRC)
CRC with greater than two years experience and with certification earned by passing required program and exam.
A medical researcher in charge of carrying out a clinical trial's protocol.
Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy. Also called clinical study and clinical investigation. Note that in this manual, this term is used in its narrow sense as used by the FDA. Thus, it does not encompass all the research that is carried out in the clinical setting (e.g., health services research).
Clinical Research Associate (CRA)
Person employed by the study sponsor or CRO to monitor a clinical study at all participating sites. See also, monitor.
Clinical Research Coordinator (CRC)
Site administer for the clinical study. Duties are delegated by the investigator. Also called research, study or healthcare coordinator, and data manager, research nurse or protocol nurse.
Clinical Study Materials
Study supplies (i.e., study test article, laboratory supplies, case report forms) provided by the study sponsor to the investigator.
Any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the agent's safety and efficacy.
1991 agreement to cover all federal-sponsored research by a common set of regulations.
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
Compliance (In Relation to Clinical Trials)
Adherence to all the trial-related requirements, good clinical practice (GCP) and ethical requirements, and the applicable regulatory requirements.
A letter sent to the investigator/institution to document their agreement to treat all information regarding the investigational product and the clinical trial in a confidential manner.
A document explaining all relevant study information to assist the study volunteer in understanding the expectations and requirements of participation in a clinical trial. This document is presented to and signed by the study subject.
Contract Research Organization (CRO)
A person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor's study-related duties and functions.
A comparison group of study subjects who are not treated with the investigational agent. The subjects in this group may receive no therapy, a different therapy, or a placebo.
The process of handling the data gathered during a clinical trial. May also refer to the department responsible for managing data entry and database generation and/or maintenance.
Refers to the characteristics of study participants, including sex, age, family medical history, and other characteristics relevant to the study in which they are enrolled.
All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records; and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.
(1) The number of doses per given time period (usually days), (2) the time that elapses between doses (e.g., dose to be given every six hours) or the time that the doses are to be given (e.g., dose to be given at 8 a.m., noon, and 4 p.m. each day) or (3) the quantity of a medicine (e.g., number of tablets, capsules, etc.) that are given at each specific time of dosing.
Drug or Device Accountability Records (DAR)
Required documentation for material accountability, quantity used and left over, and date of disposal.
Drug Safety and Monitoring Board (DSMB)
An independent committee, composed of community representatives and clinical research experts, that reviews data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved.
A product's ability to produce beneficial effects on the duration or course of a disease. Efficacy is measured by evaluating the clinical and statistical results of clinical tests.
A product's ability to produce beneficial effects on the duration or course of a disease. Efficacy is measured by evaluating the clinical and statistical results of clinical tests.
The act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process.
An independent group of both medical and non-medical professionals who are responsible for verifying the integrity of a study and ensuring the safety, integrity, and human rights of the study participants.
Refers to the characteristics that would prevent a subject from participating in a clinical trial, as outlined in the study protocol.
A drug that is not FDA licensed for use in humans, or as a treatment for a particular condition.
Food and Drug Administration (FDA)
Within the Department of Health and Human Services. Enforces Food, Drug and Cosmetics Act and related federal public health laws. Grants IND, IDE, PMA and NDA approvals.
A medicinal product with the same active ingredient, but not necessarily the same inactive ingredients as a brand-name drug. A generic drug may only be marketed after the original drug's patent has expired.
Good Clinical Practice (GCP)
International ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. Insures that the data reported is credible and accurate, and that subject's rights and confidentiality are protected.
The rate of occurrence of new cases of a disease, adverse reaction, or other event in a given population at risk (e.g., the incidence of disease X is Y subjects per year per 100,000 population).
A list of criteria that must be met by all study subjects.
The voluntary verification of a patient's willingness to participate in a clinical trial, along with the documentation thereof. This verification is requested only after complete, objective information has been given about the trial, including an explanation of the study's objectives, potential benefits, risks and inconveniences, alternative therapies available, and of 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. It is also the IRB's responsibility to ensure that the study adheres to the FDA's regulations.
A medical professional, usually a physician but may also be a nurse, pharmacist or other health care professional, under whose direction an investigational drug is administered or dispensed. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site.
Relevant clinical and non-clinical data compiled on the investigational drug, biologic or device being studied.
Legally Acceptable Representative
An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.
A study conducted over a long period of time.
Person employed by the sponsor or CRO who reviews study records to determine that a study is being conducted in accordance with the protocol. A monitor's duties may include, but are not limited to, helping to plan and initiate a study, and assessing the conduct of studies. Monitors work with the clinical research coordinator to check all data and documentation from the study. See also CRA.
Reviewing a clinical study, ensuring conduct, proper records and reports are performed as stated in the clinical protocol, standard operating procedures, GCP and by regulatory requirements.
National Institutes of Health (NIH)
Agency within DHHS that provides funding for research, conducts studies and funds multi-site national studies.
Office of Human Research Protection (OHRP)
A federal government agency that issues Assurances and overseas compliance of regulatory guidelines by research institutions.
A study in which all parties, (patient, physician and study coordinator) are informed of the drug and dose being administered. In an open-label study, none of the participants are given placebos. These are usually conducted with Phase I & II studies.
Drugs available for purchase without a physician's prescription.
Individual seeking medical care.
The medical treatment and study of children and infants, respectively. Studies in these areas include: anorexia, asthma, Attention Deficit Hyperactivity Disorder (ADHD), birth defects, cancers in children, child depression, growth deficiencies, juvenile diabetes, obesity, strep throat, vaccines, and others.
Review of a clinical trial by experts chosen by the study sponsor. These experts review the trials for scientific merit, participant safety, and ethical considerations.
The processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.
The science of drugs and poisonous materials (respectively) and their effects on the body. Studies in these areas include: diet and nutrition; overdoses; and vitamin deficiencies.
Phase I Study
The first of 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 on small populations of healthy humans to specifically determine a drug's toxicity, absorption, distribution and metabolism.
Phase II Study
After the successful completion of phase I trials, a drug is then tested for safety and efficacy in a slightly larger population of individuals who are afflicted with the disease or condition for which the drug was developed.
Phase IIa Study
Pilot clinical trials to evaluate efficacy (and safety) in selected populations of subjects with the disease or condition to be treated, diagnosed, or prevented. Objectives may focus on dose-response, type of subject, frequency of dosing, or numerous other characteristics of safety and efficacy.
Phase IIb Study
Well-controlled trials to evaluate efficacy (and safety) in subjects with the disease or condition to be treated, diagnosed, or prevented. These clinical trials usually represent the most rigorous demonstration of a medicine's efficacy.
Phase III Study
The third and last pre-approval round of testing of a drug is conducted on large populations of afflicted patients. Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease in question. The results of these trials usually provide the information that is included in the package insert and labeling.
Trials conducted after efficacy of the medicine is demonstrated, but prior to regulatory submission of a New Drug/product Application (NDA) or other dossier. These clinical trials are conducted in subjects' populations for which the medicine is eventually intended. Phase IIIa clinical trials generate additional data on both safety and efficacy in relatively large numbers of subjects in both controlled and uncontrolled trials. Clinical trials are also conducted in special groups of subjects (e.g. renal failure subjects), or under special conditions dictated by the nature of the medicine and disease. These trials often provide much of the information needed for the package insert and labeling of the medicine.
Phase IIIb Study
Clinical trials conducted after regulatory submission of an NDA or other dossier, but prior to the medicine's approval and launch. These trials may supplement earlier trials, complete earlier trials, or may be directed towards new types of trials (e.g., quality of life, marketing) or phase IV evaluations. This is the period between submission and approval of a regulatory dossier for marketing authorization.
Phase IV Study
After a drug has been approved by the FDA, phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse events.
A pilot trial is used to obtain information, and work out the logistics and management, deemed necessary for further clinical trials. Although pilot trials are often unblind and use open-label medicines, they may also be single or double blind and may include tight control on all appropriate variables. The term "pilot" refers to the purpose of the trial (2).
An inactive substance designed to resemble the drug being tested. It is used as a control to rule out any psychological effects testing may present. Most well-designed studies include a control group which is unwittingly taking a placebo.
Refers to trials to find better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
A detailed plan that sets forth the objectives, study design, and methodology for a clinical trial. A study protocol must be approved by an IRB before investigational drugs may be administered to humans.
Changes or clarifications made in writing to the original protocol.
Study participants are usually assigned to groups in such a way that each participant has an equal chance of being assigned to each treatment (or control) group. Since randomization ensures that no specific criteria are used to assign any patients to a particular group, all the groups will be equally comparable.
Act of enrolling subjects with the proper inclusion criteria.
Time allowed to recruit all subjects for a study.
Systematic investigation designed to develop or contribute to generalizable knowledge. Includes Clinical Research.
Investigator, subinvestigator and clinical research coordinator involved with study.
A measure of (1) the probability of occurrence of harm to human health or (2) the severity of harm that may occur. Such a measure includes the judgment of the acceptability of risk. Assessment of safety involves judgment, and there are numerous perspectives (e.g., subjects, physicians, company, regulatory authorities) used for judging it.
Risk to individual subject vs. potential benefits. Also called Risk-Benefit Analysis.
FDA report required by investigator for any serious and unexpected adverse experience.
Refers to trials which test the best way to detect certain diseases or health conditions.
Serious Adverse Event (SAE)
Any adverse event (AE) that is fatal, life-threatening, permanently disabling, or which results in hospitalization, initial or prolonged.
Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects.
A study in which one party, either the investigator or participant, is unaware of what medication the participant is taking; also called single-masked study.
Location where information is first recorded including original documents, data and records.
Individual, company, institution or organization taking responsibility for initiation, management and financing of study.
Standard Operating Procedure (SOP)
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 in a consistent and efficient manner.
Standards of Care
Treatment regimen or medical management based on state of the art participant care.
The probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed.
Participant in a study. See "Human Subject."
Unexpected Adverse Drug Reaction
A reaction that is not consistent in nature or severity with study application.
Group/individual that cannot give informed consent because of limited autonomy (e.g., children, mentally ill and prisoners). Also refers to subjects who may be unduly influenced to participate (e.g., students, subordinates and patients).