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Back To Vidyya Evidence Based Medicine Vocabulary Primer

Presenting Viddya's evidence-based medicine vocabulary primer. If it's a term used in clinical trial medicine, you'll find it in our list.

action letters - An official communication from FDA that informs of a decision by the agency. An approval letter allows commercial marketing of the product. An approvable letter lists minor issues to be resolved before approval will be issued. A not approvable letter describes important deficiencies that will cause denial of approval unless corrected. (FDA)

adverse drug reaction (ADR) - In the pre-approval clinical experience as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product 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 (ICH)

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. An adverse event (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. (ICH)

algorithm - A step-by-step protocol for management of a health care problem (Stedman's)

alpha error - Error made when a correct null hypothesis is rejected. (ACT)

ANOVA - Analysis of variance. (ACT)

approval (in relation to institutional review boards - IRB) - The affirmation 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)

audit (of a clinical trial) - 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)

audit certificate - A declaration of confirmation by that an audit has taken place at an investigative site, CRO, or clinical research department of a pharmaceutical company. (ICH)

audit report - A written evaluation by the sponsor's auditor of the results of the audit. (ICH)

audit trail - Documentation that allows reconstruction of the course of events. (ICH)

beta error - Error made when an incorrect null hypothesis is not rejected. (ACT)

between-subject variation - In a parallel trial design, differences between subjects are used to assess treatment differences. (ACT)

blind study - Study in which the experimenter is unaware of which group is subject to which procedure. (Stedman's) There are also double-blind, single-blind and triple-blind studies.

blinding/masking - 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)

carry-over effect - Effects of treatment that persist after treatment has been stopped, sometimes beyond the time of a medication's known biological activity. (ACT)

case record form or 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)

categorical data - Data evaluated by sorting values into various categories (for example, severe, moderate, and mild). (ACT)

causality assessment - Determining whether there is a reasonable possibility that the drug caused or contributed to an adverse event. It includes assessing temporal relationships, dechallenge/rechallenge information, association (or lack of association) with underlying disease, and the presence (or absence) of a more likely cause. (ACT)

clinical practice guideline - a systematically developed statement designed to assist practitioner and patient make decisions about appropriate health care for specific clinical circumstances. (CEBM)

clinical research associate (CRA) - Person employed by a sponsor, or by a contract research organization acting on a sponsor's behalf, who monitors the progress of investigator sites participating in a clinical study. At some (primarily academic) sites, clinical research coordinators are called CRAs. (ACT)

clinical research coordinator (CRC) - Person who handles most of the administrative responsibilities of a clinical trial, acts as liaison between investigative site and sponsor, and reviews all data and records before a monitor's visit. Synonyms: trial coordinator, study coordinator, research coordinator, clinical coordinator, research nurse, protocol nurse. (ACT)

clinical significance - Change in a subject's clinical condition regarded as important whether or not due to the test article. Some statistically significant changes (in blood tests, for example) have no clinical significance. The criterion or criteria for clinical significance should be stated in the protocol. (ACT)

clinical trial/study/investigation - Systematic study of a test article (treatment, drug, device) in one or more human subjects. Synonyms: clinical study, clinical investigation. (21 CFR 50.3)

clinical trial/study - Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s), with the object of ascertaining its safety and/or efficacy. The terms "clinical trial" and "clinical study" are synonymous. (ICH)

clinical trial/study report - A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report (ICH)

cohort - Any designated group followed or traced over a period. (Stedman's)

cohort study - Using epidemiological methods, such as a clinical trial, in which a cohort with a particular attribute (e.g. recipients of a drug) is followed prospectively and compared for some outcome (e.g. disease, cure) with another cohort not possessing the attribute. (Stedman's)

comparator (product) - An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. (ICH)

comparative study - One in which the product, drug or biological is compared to another product, either active drug, placebo or product. (ACT)

compliance (in relation to trials) - Adherence to all the trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. (ICH)

confidence intervals (CI) - The confidence interval gives the range in which you think the real answer lies with a given degree of certainty. (e.g. If you have a bag--which you cannot see into--containing thirty sweets that could be either orange or white, then the number of orange sweets in the bag at the start could lie between zero and thirty, i.e. the confidence interval for the number of orange sweets is 0 - 30 (CI = 0 - 30))(AB).

confidentiality - Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. (ICH)

consumer safety officer - FDA official who coordinates the review process of various applications. (FDA)

contract - A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract. (ICH)

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 trial-related duties and functions. (ICH)

control group - The group of subjects in a comparison group that differs in disease experience or allocation to a regimen from the subjects of a given study. (Stedman's)

controlled study - A study in which a test article is compared with a treatment that has known effects. The control group may receive no treatment, standard treatment, or placebo. (ACT)

coordinating committee - A committee that a sponsor may organize to coordinate the conduct of a multicenter trial. (ICH)

coordinating investigator - An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial. (ICH)

crossover trial - a trial in which the subject is switched from the experimental to the control procedure (or vice versa). (Stedman's)

Declaration of Helsinki - A set of recommendations or basic principles that guide medical doctors in the conduct of biomedical research involving human subjects. It was adopted by the 18th World Medical Assembly (Helsinki, Finland, 1964) and revised by the 29th (Tokyo, 1975) and 35th (Venice, Italy, 1983) World Medical Assemblies. The full text is in 21 CFR 312.120. (CFR)

demographic data - Population based data, especially with reference to size, density, fertility, mortality, growth rate, age distribution, migration and vital statistics of a given set of subjects. (Stedman's)

direct access - Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subject's identities and sponsor's proprietary information. (ICH)

documentation - 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. (ICH)

double-blind study - A study in which neither the experimenter nor any other assessor of the results, including patients, know which group is subject to which procedure, thus helping assure that the biases of expectations of either will not influence the results. (Stedman's)

effectiveness - A measure of the accuracy or success of a diagnostic or therapeutic technique when carried out in an average clinical environment. (Stedman's)

efficacy - The extent to which a specific intervention, procedure, regimen, or service produces a beneficial result under ideal conditions. (Stedman's)

endpoint - An indicator measured in a subject or biological sample to assess the safety, efficacy, or other objective of a trial. See also surrogate marker. (ACT)

equipoise - A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient. An investigator who has a treatment preference or finds out that one arm of a comparative trial offers a clinically therapeutic advantage should disclose this information to subjects participating in the trial. (ACT)

essential documents - Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. (ICH)

evidence-based health care - The application of the principles of Evidence-Based Medicine (see below) to all professions associated with health care, including purchasing and management. (CEBM)

evidence-based medicine (EBM) - "Evidence-based medicine involves integrating current best evidence with clinical expertise, pathophysiological knowledge, and patient preferences in making decisions about the care of individual patients." (Sacket et al. Evidence based medicine ... BMJ 1996 7023 312:71-72) (CEBM)

exclusion criteria - A list of criteria, any one of which excludes a potential subject from participation in a study. (ACT)

external consistency - The consistency of a procedure between sets of data. (ACT)

final report - Complete, comprehensive description of a completed trial that describes the experimental materials and statistical design. It also presents and evaluates the trial results and statistical analyses. (ACT)

first-in-humans study - The first Phase 1 study in which the test product is administered to human beings. (ACT)

first-in-man study - Same as first-in-humans study. (ACT)

Food and Drug Administration (FDA) - The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals. (ACT)

good clinical practice (GCP) - A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. (ICH)

healthy volunteer - A healthy person who agrees to participate in a clinical trial for reasons other than medical and receives no direct health benefit from participating. (ACT)

human subject - An "individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient." Synonym: subject/trial subject. ( 21 CFR 50.3)

impartial witness - A person, which is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject. (ICH)

inclusion criteria - The criteria that prospective subjects must meet to be eligible for participation in a study. (ACT)

independent data-monitoring committee (IDMC) - A committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. Also known as Data and Safety Monitoring Board DSMB or Data Monitoring Committee (ICH)

independent ethics committee (IEC) - An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations, and regulatory requirements pertaining to independent ethics committees may differ among countries, but should allow the independent ethics committee to act in agreement with GCP as described in the [ICH] guideline. (ICH)

informed consent - A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form. (ICH) Under 21 CFR 50.20, no informed consent may include any "language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence." (CFR)

inspection - The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). (ICH)

institution (medical) - Any public or private entity or agency or medical or dental facility where clinical trials are conducted. (ICH)

institutional review board (IRB) - An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. (ICH)

interim clinical trial/study report - A report of intermediate results and their evaluation based on analyses performed during the course of a trial. (ICH)

investigational product - A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. (ICH)

investigator - A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. (ICH).

investigator/institution - An expression meaning "the investigator and/or institution, where required by the applicable regulatory requirements." (ICH)

investigator's brochure - A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects. (ICH)

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. (ICH)

likelihood ratio - The likelihood that a given test result would be expected in a patient with the target disorder compared to the likelihood that the same result would be expected in a patient without that disorder. (CEBM)

longitudinal study - A study of the natural course of a life or disorder in which a cohort of subjects is serially observed over a period of time and no assumptions need be made about the stability of the system. (e.g. The Framingham Study) (Stedman's).

matched-pair design - A type of trial design in which a study group and a comparison group in an epidemiological study are comparable with respect to extraneous or confounding factors such as age, sex, weight etc. The pairs of subjects from the study and comparison groups are then randomized so that one receives Treatment A and the other Treatment B. (Stedman's)

matching - The process of making a study group and a comparison group in an epidemiological study comparable with respect to extraneous or confounding factors such as age, sex, weight, etc. (Stedman's)

mean - Statistical measurement of central tendency or average of a set of values, usually assumed to be the arithmetic mean unless otherwise specified. (Stedman's)

median - The middle value in a set of measurements; like the mean, a measure of central tendency. (Stedman's)

megatrials - Massive randomized clinical trials that test the advantages of marginally effective experimental drugs by enrolling 10,000 or more subjects. (ACT)

meta-analysis - The process of using statistical methods to combine the results of different studies; systematic, organized and structured evaluation of a problem using information, commonly in the form of statistical tables, etc., from a number of different studies of the problem. (Stedman's)

mode - In a set of measurements, that value which appears most frequently (Stedman's)

monitoring - The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). (ICH)

monitoring report - A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor's SOPs. (ICH)

multicenter trial - A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. (ICH) Synonym: multicenter study

negative predictive value (-PV) - The proportion of people with a negative test who are free of disease. (CEMB)

New Drug Application (NDA) - An application to FDA for a license to market a new drug in the United States. (FDA)

nonclinical study - Biomedical studies not performed on human subjects. (ICH)

null hypothesis - A hypothesis used to rule out every possibility except the one the researcher is trying to prove. It is usually used to prove a statement is false, as most statistical methods make it difficult to prove a hypothesis is true. (ACT)

number needed to treat (NNT) - NNT is the number of people who (on average) need to receive a treatment to produce one additional successful outcome.
Q. How effective is nicotine chewing gum in helping people stop smoking for at least one year?
A. We need to treat 13 smokers by giving them nicotine gum, for one extra person to stop smoking, ie. NNT = 13. (AB)

Nuremberg Code - Code of ethics for conducting medical research set forth in 1947. (ACT)

open study - A trial in which subjects and investigators know which product each subject is receiving; opposite of double-blind study. (ACT)

opinion - (in relation to independent ethics committee) The judgment and/or the advice provided by an independent ethics committee. (ICH)

p value (statistics) - The lowest level of significance at which a given null hypothesis can be rejected; that is, the necessary criterion for determining that the result probably did not happen by chance. (ACT)

pairing - See matching.

parallel trial - Volunteers are randomized to one of two differing treatment groups (usually medicine and placebo) and usually receive the assigned treatment during the entire trial. Also called parallel group trial, parallel design trial. (ACT)

period effect - Designated period during the course of a trial in which subjects are observed and no treatment is administered. (ACT)

pharmacodynamics (PD) - The study of uptake, movement, binding, and interactions of pharmacologically active molecules at their tissue site(s) of action. (Stedman's)

pharmacoeconomics - Branch of economics that applies cost-benefit, cost-effectiveness, cost-minimization, and cost-utility analyses to compare the economics of different pharmaceutical products or to compare drug therapy to other treatments. Sometimes referred to as outcomes research. (ACT)

pharmacogenetics - The study of genetically determined variations in responses to drugs in humans or in laboratory organisms (Stedman's).

pharmacokinetics (PK) - Movements of drugs within biological systems, as affected by uptake, distribution, binding, elimination and biotransformation, particularly the rates of such movement. (Stedman's)

pharmacology - The science concerned with the drugs, their sources, appearance, chemistry, actions, and uses. (Stedman's)

Phase 1 unit - A facility designed specifically for conducting studies involving normal, healthy volunteers. It may be operated by a sponsor company, a contract research organization (CRO), or a special unit of a hospital. (ACT)

phases of clinical trials - Clinical trials are generally categorized into four (sometimes five) phases. An investigational medicine or product may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases. (ACT)

Phase 1 studies. - Initial safety trials on a new medicine in which investigators attempt to establish the dose range tolerated by about 20 to 80 healthy volunteers for single and multiple doses. Although usually conducted with healthy volunteers, Phase 1 trials are sometimes conducted with severely ill patients, for example, those with cancer or AIDS. When pharmacokinetic issues are being addressed (for example, metabolism of a new antiepileptic medicine in stable epileptic patients whose microsomal liver enzymes have been induced by other antiepileptic medicines), trials may be conducted in less-ill patients. Pharmacokinetic trials are usually considered Phase 1 trials regardless of when they are conducted during a medicine's development. (ACT)

Phase 2a studies. - Pilot clinical trials to evaluate efficacy and safety in selected populations of about 100 to 300 patients who have the disease or condition to be treated, diagnosed, or prevented. Often involve hospitalized patients who can be closely monitored. Objectives may focus on dose-response, type of patient, frequency of dosing, or any of a number of other issues involved in safety and efficacy. (ACT)

Phase 2b studies. - Well-controlled trials to evaluate safety and efficacy in patients who have the disease or condition to be treated, diagnosed, or prevented. These trials usually represent the most rigorous demonstration of a medicine's efficacy. Synonym: pivotal trials. (ACT)

Phase 3 studies. - Multicenter studies in populations of perhaps 1000 to 3000 patients (or more) for whom the medicine is eventually intended. Phase 3 trials generate additional safety and efficacy data from relatively large numbers of patients in both controlled and uncontrolled designs and are used to support a PLA. Trials are also conducted in special groups of patients or under special conditions dictated by the nature of a particular medicine and/or disease. Phase 3 trials often provide much of the information needed for the package insert and labeling of the medicine. (ACT)

Phase 3b studies. - Trials conducted after submission of a new drug application (NDA), but before the product's approval and market launch. Phase 3b trials may supplement or complete earlier trials, or they may seek different kinds of information (for example, quality of life or marketing). Phase 3b is the period between submission for approval and receipt of marketing authorization. (ACT)

Phase 4 studies. - After a medicine is marketed, Phase 4 trials provide additional details about the product's safety and efficacy. They may be used to evaluate formulations, dosages, durations of treatment, medicine interactions, and other factors. Patients from various demographic groups may be studied. An important part of many Phase 4 studies is detecting and defining previously unknown or inadequately quantified adverse reactions and related risk factors. Phase 4 studies that are primarily observational or nonexperimental are frequently called postmarketing surveillance. (ACT)

Phase 5 studies. - Postmarketing surveillance is sometimes referred to as Phase 5. (ACT)

placebo - An inert substance given as a medicine for its suggestive effect. In experiments, an inert compound identical in appearance to material being tested in the research, which may or may not be known to the physician and/or patient, administered to distinguish between drug action and suggestive effect of the material under study. (Stedman's)

positive predictive value (+PV) - the proportion of people with a positive test who have disease. (CEBM)

postmarketing surveillance - Ongoing safety monitoring of marketed drugs. (FDA)

preclinical studies - Animal studies that support Phase 1 safety and tolerance studies and must comply with good laboratory practice (GLP). Data about a drug's activities and effects in animals help establish boundaries for safe use of the drug in subsequent human testing (clinical studies or trials). Because many animals have much shorter life spans than humans, preclinical studies can provide valuable information about a drug's possible toxic effects over an animal's life cycle and on its offspring. (ACT)

prospective study - Using epidemiological methods, such as a clinical trial, in which a cohort with a particular attribute (e.g. recipients of a drug) is followed prospectively and compared for some outcome (e.g. disease, cure) with another cohort not possessing the attribute. (also known as a cohort study) (Stedman's)

protocol - A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term "protocol" refers to protocol and protocol amendments. (ICH)

protocol amendment - A written description of a change(s) to or formal clarification of a protocol. (ICH)

qualitative variable - One that cannot be measured numerically (race or sex, for example). (ACT)

quantitative variable - One that can be measured (blood pressure, for example). (ACT)

quality assurance (QA) - All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s). (ICH)

quality control (QC) - The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. (ICH)

random allocation - Assignment of subjects to treatment (or control) groups in an unpredictable way. Assignment sequences are concealed, but available for disclosure in the event a subject has an adverse experience. (ACT)

random sample - Members of a population selected by a method designed to ensure that each person in the target group has an equal chance of selection. (ACT)

random number table - Table of numbers with no apparent pattern used in the selection of random samples for clinical trials. (ACT)

randomization - The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (ICH)

raw data - Records of original observations, measurements, and activities (such as laboratory notes, evaluations, data recorded by automated instruments) without conclusions or interpretations. (ACT)

regulatory authorities - Bodies having the power to regulate. In the ICH GCP guideline the expression "regulatory authorities" includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities. (ICH)

relative risk (RR) - RR is calculated by taking the ratio between two measures of risk, if there is no difference between the two groups the RR will be one ie. there is no treatment effect). This is because the risk in each group is the same and a number divided by itself is always one. In a controlled trial, if the outcome is something we want (like stopping smoking) then a RR greater than one means the treatment is better than the control; if it is less than one it is worse. If the outcome is something we do not want (like death) then a RR greater than one means the treatment is worse and a RR less than one means that the treatment is better. (AB)

research hypothesis - The research hypothesis is the conclusion a study sets out to support (or disprove); for example, "blood pressure will be lowered by [specific endpoint] in subjects who receive the test product." See also null hypothesis. (ACT)

risk - In clinical trials, the probability of harm or discomfort for subjects. Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat, for example, will be expected to have a low incidence of side effects. However, unpleasant side effects may be an acceptable risk when testing a promising treatment for a life-threatening illness. (ACT)

safety - Relative freedom from harm; in clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests and procedures, psychiatric evaluation, and/or physical examination of subjects. (ACT)

sensitivity - the proportion of people with disease who have a positive test. (CEBM)

serious adverse event (SAE) or serious adverse drug reaction (serious ADR) - Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (ICH)

single-blind study - One in which subjects do not know whether they are receiving the active drug or a placebo. (ACT)

source data - All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). (ICH)

source documents - Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial). (ICH)

specificity - the proportion of people free of a disease who have a negative test. (CEBM)

sponsor - An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. (ICH)

sponsor-investigator - An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. (ICH)

standard deviation (statistics) - Indicator of the relative variability of a variable around its mean; the square root of the variance. (ACT)

standard operating procedures (SOPs) - Detailed, written instructions to achieve uniformity of the performance of a specific function. (ICH)

statistical significance - Level at which an investigator can conclude that observed differences are not due to chance alone; for example, a p value of .05 (also called significance at the .05 level) indicates that there is about 1 chance in 20 that the differences observed occurred by chance alone. (ACT)

subinvestigator - Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). (ICH)

subject/trial subject - An individual who participates in a clinical trial, either as recipient of the investigational product(s) or as a control. (ICH)

subject identification code - A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial-related data. (ICH)

t-test - A statistical test used to compare the means of two groups of test data. (ACT)

trial site - The location(s) where trial-related activities are actually conducted. (ICH)

triple-blind study - A study in which knowledge of the treatment is concealed from the people who organize and analyze the data of a study as well as from subjects and investigators. (ACT)

Type 1 error (statistics) - Error made when a correct null hypothesis is rejected. (ACT)

Type 2 error (statistics) - Error made when an incorrect null hypothesis is not rejected. (ACT)

unequal randomization - A technique used to allocate subjects into groups at a differential rate; for example, three subjects may be assigned to a treatment group for every one assigned to the control group. (ACT)

unexpected adverse drug reaction - An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., investigator's brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product). (ICH)

validation of data - The act or process of making valid that the data contained in the final clinical trial report matches original observations. (Stedman's)

validity - An index of how well a test or procedure in fact measures what it purports to measure; an objective index by which to describe how valid a test or procedure is. (Stedman's)

variance - A measure of the variation shown by a set of observations, defined as the sum of squares of deviations from the mean, divided by the number of degress of freedom in the set of observations. (Stedman's).

vulnerable subjects - Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. (ICH)

weighting - An adjustment in a value on the basis of a judgment by the investigator. (ACT)

well-being (of the trial subjects) - The physical and mental integrity of the subjects participating in a clinical trial. (ICH)

within-patient differences - In a crossover trial, variability in each patient is used to assess treatment differences. (ACT)

Sources of Definitions:

Definitions for this glossary are from the sources below.

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