A glossary of terms used in clinical research. __NOTOC__
A
Activities of daily living The tasks of everyday life. These activities include eating, dressing, getting into or out of a bed or chair, taking a bath or shower, and using the toilet. Instrumental activities of daily living are activities related to independent living and include preparing meals, managing money, shopping, doing housework, and using a telephone. Also called ADL. (NCI)
Adverse drug reaction In the preapproval 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 that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function. (ICH E6)
Adverse effect An unwanted side effect of treatment. (NCI)
Adverse event An unexpected medical problem that happens during treatment with a drug or other therapy. Adverse events do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe. (NCI) An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). (ICH E6)
Adverse reaction An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time (NLM)
Advocacy and support groups Organizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools. (NLM)
Animal model An animal with a disease either the same as or like a disease in humans. Animal models are used to study the development and progression of diseases and to test new treatments before they are given to humans. (NCI)
Animal study A laboratory experiment using animals to study the development and progression of diseases. Animal studies also test how safe and effective new treatments are before they are tested in people. (NCI)
Applicable regulatory requirement Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products of the jurisdiction where trial is conducted. (ICH E6)
Approval (in relation to institutional review boards (IRBs)) The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements. (ICH E6)
Approved drugs 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 (NLM)
Arm Any of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more (NLM)
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). (ICH E6)
Audit certificate A declaration of confirmation by the auditor that an audit has taken place. (ICH E6)
Audit report A written evaluation by the sponsor's auditor of the results of the audit. (ICH E6)
Audit trail Documentation that allows reconstruction of the course of events. (ICH E6)
B
Baseline 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. (NLM) An initial measurement that is taken at an early time point to represent a beginning condition, and is used for comparison over time to look for changes. For example, the size of a tumor will be measured before treatment (baseline) and then afterwards to see if the treatment had an effect. (NCI)
Bayesian approaches Approaches to data analysis that provide a posterior probability distribution for some parameter (e.g. treatment effect), derived from the observed data and a prior probability distribution for the parameter. The posterior distribution is then used as the basis for statistical inference. (ICH E9)
Best practice In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with the best practice. Also called standard therapy or standard of care. (NCI)
Bias In a scientific research study or clinical trial, a flaw in the study design or the method of collecting or interpreting information. Biases can lead to incorrect conclusions about what the study or clinical trial showed. (NCI) 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 (NLM) The systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the results of a clinical trial to make the estimate of a treatment effect deviate from its true value. Bias introduced through deviations in conduct is referred to as 'operational' bias. The other sources of bias listed above are referred to as 'statistical'. (ICH E9)
Bioavailable The ability of a drug or other substance to be absorbed and used by the body. Orally bioavailable means that a drug or other substance that is taken by mouth can be absorbed and used by the body. (NCI)
Bioinformatics The science of using computers, databases, and math to organize and analyze large amounts of biological, medical, and health information. Information may come from many sources, including patient statistics, tissue specimens, genetics research, and clinical trials. (NCI)
Biological drug A substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment diseases. Biological drugs include antibodies, interleukins, and vaccines. Also called biologic agent or biological agent. (NCI)
Biometrics The science of collecting and analyzing biologic or health data using statistical methods. Biometrics may be used to help learn the possible causes of a disease in a certain group of people. Also called biostatistics and biometry. (NCI)
Biometry The science of collecting and analyzing biologic or health data using statistical methods. Biometry may be used to help learn the possible causes of a disease in a certain group of people. Also called biostatistics and biometrics. (NCI)
Biostatistics The science of collecting and analyzing biologic or health data using statistical methods. Biostatistics may be used to help learn the possible causes of a disease in a certain group of people. Also called biometry and biometrics. (NCI)
Blind A randomized trial is "Blind" if the participant is not told which arm of the trial he is on. A clinical trial is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. (NLM) A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single blinding usually refers to the subject(s) being unaware, and double blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). (ICH E6)
Blind review The checking and assessment of data during the period of time between trial completion (the last observation on the last subject) and the breaking of the blind, for the purpose of finalising the planned analysis. (ICH E9)
Blinded study A type of study in which the patients (single-blinded) or the patients and their doctors (double-blinded) do not know which drug or treatment is being given. The opposite of a blinded study is an open label study. (NCI)
C
Candidate A descriptor which is applied to any substance or process which is being investigated for clinical use but either has not commenced, or has not completed, clinical trials. Examples: candidate vaccine, candidate formulation.
Case report A detailed report of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin). (NCI)
Case report form A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. (ICH E6)
Case series A group or series of case reports involving patients who were given similar treatment. Reports of case series usually contain detailed information about the individual patients. This includes demographic information (for example, age, gender, ethnic origin) and information on diagnosis, treatment, response to treatment, and follow-up after treatment. (NCI)
Case-control study A study that compares two groups of people: those with the disease or condition under study (cases) and a very similar group of people who do not have the disease or condition (controls). Researchers study the medical and lifestyle histories of the people in each group to learn what factors may be associated with the disease or condition. For example, one group may have been exposed to a particular substance that the other was not. Also called a retrospective study. (NCI)
Clinical Pertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. (NLM)
Clinical investigation Any experiment that involves a test article and one or more human subjects (21CFR50.3)
Clinical investigator A medical researcher in charge of carrying out a clinical trial's protocol. (NLM)
Clinical practice guidelines Guidelines developed to help health care professionals and patients make decisions about screening, prevention, or treatment of a specific health condition. (NCI)
Clinical researcher A health professional who works directly with patients, or uses data from patients, to do research on health and disease and to develop new treatments. Clinical researchers may also do research on how health care practices affect health and disease. (NCI)
Clinical series A case series in which the patients receive treatment in a clinic or other medical facility. (NCI)
Clinical study or Clinical trial