A glossary of terms used in clinical research.
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
A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called a clinical trial. (NCI) A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. (NLM) 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 E6) 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 E6) Clinician
A health professional who takes care of patients. (NCI) Cohort (statistics)
A group of individuals who share a common trait, such as birth year. In medicine, a cohort is a group that is part of a clinical trial or study and is observed over a period of time. (NCI) In epidemiology, a group of individuals with some characteristics in common. (NLM) Cohort study
A research study that compares a particular outcome in groups of individuals who are alike in many ways but differ by a certain characteristic (for example, female nurses who smoke compared with those who do not smoke). (NCI) Community-based clinical trial (CBCT)
A clinical trial conducted primarily through primary-care physicians rather than academic research facilities. (NLM) Comparator
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. (ICH E6) Compassionate use
A method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy. (NLM) Compassionate use trial
A way to provide an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available. Compassionate use trials allow patients to receive promising but not yet fully studied or approved therapies when no other treatment option exists. Also called expanded access trial. (NCI) Complementary and alternative therapy
Broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or treat health conditions. Examples include acupuncture, herbs, etc. Internet Address: http://www.nccih.nih.gov. (NLM) Compliance
Adherence to all the trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. (ICH E6) Confidentiality regarding trial participants
Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants' consent to the use of records for data verification purposes should be obtained prior to the trial and assurance must be given that confidentiality will be maintained. (NLM) Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. (ICH E6) Consecutive case series
A clinical study that includes all eligible patients identified by the researchers during the study registration period. The patients are treated in the order in which they are identified. This type of study usually does not have a control group. (NCI) Content validity
The extent to which a variable (e.g. a rating scale) measures what it is supposed to measure. (ICH E9) 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 E6) Contract Research Organization
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 E6) Contraindication
A specific circumstance when the use of certain treatments could be harmful. (NLM) Control
A control is the nature of the intervention control. (NLM) Control animal
An animal in a study that does not receive the treatment being tested. Comparing the health of control animals with the health of treated animals allows researchers to evaluate the effects of a treatment more accurately. (NCI) Control group
In a clinical trial, the group that does not receive the new treatment being studied. This group is compared to the group that receives the new treatment, to see if the new treatment works. (NCI) The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo (NLM) Controlled clinical trial
A clinical study that includes a comparison (control) group. The comparison group receives a placebo, another treatment, or no treatment at all. (NCI) An experiment or clinical trial that includes a comparison (control) group. (NCI) Controlled trials
Control is a standard against which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimental drug, while another group (i.e., the control group) is given either a standard treatment for the disease or a placebo. (NLM) Coordinating Committee
A committee that a sponsor may organize to coordinate the conduct of a multicenter trial. (ICH E6) Coordinating Investigator
An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial. (ICH E6)
D Data and Safety Monitoring Board or Independent Data Monitoring Committee
DSMB. An impartial group that oversees a clinical trial and reviews the results to see if they are acceptable. This group determines if the trial should be changed or closed. Also called DSMB. (NCI) 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. (NLM) An independent data monitoring 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. (ICH E6 and ICH E9) Diagnostic trials
Refers to trials that are conducted to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usually include people who have signs or symptoms of the disease or condition being studied. (NLM) 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, sponsors, 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 subjects' identities and sponsor's proprietary information. (ICH E6) 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 E6) Dose
The amount of medicine taken, or radiation given, at one time. (NCI) Dose-dependent
Refers to the effects of treatment with a drug. If the effects change when the dose of the drug is changed, the effects are said to be dose-dependent. (NCI) Dose-limiting
Describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. (NCI) Dose-ranging study
A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful. (NLM) Dose-rate
The strength of a treatment given over a period of time. (NCI) Double-blind study
A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study. (NLM) A clinical trial in which neither the medical staff nor the person knows which of several possible therapies the person is receiving. (NCI) Double-dummy
A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Supplies are prepared for Treatment A (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). Subjects then take two sets of treatment; either A (active) and B (placebo), or A (placebo) and B (active). (ICH E9) Dropout
A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the study protocol. (ICH E9) Drug
Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic. (NCI) Drug–drug interaction
A modification of the effect of a drug when administered with another drug. The effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug. (NLM)
E Efficacy
The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the procedure mandated by the FDA, Phase II clinical trials gauge efficacy, and Phase III trials confirm it (NLM) Effectiveness. In medicine, the ability of an intervention (for example, a drug or surgery) to produce the desired beneficial effect. (NCI) Eligibility criteria
In clinical trials, requirements that must be met for an individual to be included in a study. These requirements help make sure that patients in a trial are similar to each other in terms of specific factors such as age, general health, and previous treatment. When all participants meet the same eligibility criteria, it gives researchers greater confidence that results of the study are caused by the intervention being tested and not by other factors. (NCI) Summary criteria for participant selection; includes Inclusion and Exclusion criteria. (NLM) Empirical
Based on experimental data, not on a theory. (NLM) Endpoint
In clinical trials, an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial. The endpoints of a clinical trial are usually included in the study objectives. Some examples of endpoints are survival, improvements in quality of life, relief of symptoms, and disappearance of the tumor. (NCI) Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death. (NLM) Enrolling
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. (NLM) Epidemiology
The branch of medical science that deals with the study of incidence and distribution and control of a disease in a population. (NLM) The study of the patterns, causes, and control of disease in groups of people. (NCI) Equivalence trial
A trial with the primary objective of showing that the response to two or more treatments differs by an amount which is clinically unimportant. This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences. (ICH E9) Essential Documents
Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. (ICH E6) Evaluable disease
Disease that cannot be measured directly by the size of the tumor but can be evaluated by other methods specific to a particular clinical trial. (NCI) Evaluable patients
Patients whose response to a treatment can be measured because enough information has been collected. (NCI) Expanded access
Refers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials. (NLM) Expanded access trial
A way to provide an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available. Expanded access allows a patient to receive promising but not yet fully studied or approved therapies when no other treatment option exists. Also called compassionate use trial. (NCI) Experimental
In clinical trials, refers to a drug (including a new drug, dose, combination, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the U.S. Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered experimental in other diseases or conditions. Also called investigational. (NCI) Experimental drug
A drug that is not FDA licensed for use in humans, or as a treatment for a particular condition (NLM) A substance that has been tested in a laboratory and has gotten approval from the U.S. Food and Drug Administration (FDA) to be tested in people. A drug may be approved by the FDA for use in one disease or condition but be considered experimental or investigational in other diseases or conditions. Also called investigational drug. (NCI)
F Follow-up
Monitoring a person's health over time after treatment. This includes keeping track of the health of people who participate in a clinical study or clinical trial for a period of time, both during the study and after the study ends. (NCI) Food and Drug Administration (FDA)
The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. Internet address: https://www.fda.gov/. (NLM) Frequentist methods
Statistical methods, such as significance tests and confidence intervals, which can be interpreted in terms of the frequency of certain outcomes occurring in hypothetical repeated realisations of the same experimental situation. (ICH E9) Full analysis set
The set of subjects that is as close as possible to the ideal implied by the intention-to- treat principle. It is derived from the set of all randomised subjects by minimal and justified elimination of subjects. (ICH E9)
G Generalisability, Generalisation
The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings. (ICH E9) Global assessment variable
A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator's overall impression about the state or change in state of a subject. (ICH E9) Good clinical practice
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 E6)
H Healthy control
In a clinical study, a person who does not have the disorder or disease being studied. Results from healthy controls are compared to results from the group being studied. (NCI) Historic cohort study
A research study in which the medical records of groups of individuals who are alike in many ways but differ by a certain characteristic (for example, female nurses who smoke and those who do not smoke) are compared for a particular outcome. Also called a retrospective cohort study. (NCI) Historical control subject
An individual treated in the past and used in a comparison group when researchers analyze the results of a clinical study that had no control group. The use of a control, or comparison, group helps researchers determine the effects of a new treatment more accurately. (NCI) 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. (21CFR50.3) Hypothesis
A supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation. (NLM)
I Impartial Witness
A person, who 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 E6) In vitro
In the laboratory (outside the body). The opposite of in vivo (in the body). (NCI) In vivo
In the body. The opposite of in vitro (outside the body or in the laboratory). (NCI) Incidence
The number of new cases of a disease diagnosed each year. (NCI) Inclusion/exclusion criteria
The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe. (NLM) Independent Ethics Committee
An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and nonmedical/nonscientific 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 this guidance. (ICH E6) Indication
In medicine, a sign, symptom, or medical condition that leads to the recommendation of a treatment, test, or procedure. (NCI) Informed consent
A process in which a person is given important facts about a medical procedure or treatment, a clinical trial, or genetic testing before deciding whether or not to participate. It also includes informing the patient when there is new information that may affect his or her decision to continue. Informed consent includes information about the possible risks, benefits, and limits of the procedure, treatment, trial, or genetic testing. (NCI) The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. (NLM) 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 E6) Informed consent document
A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time. (NLM) 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 (CROs) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). (ICH E6) Institution
Any public or private entity or agency or medical or dental facility where clinical trials are conducted. (ICH E6) Any public or private entity or agency (including Federal, State, and other agencies). (21CFR50.3) Institutional Review Board (IRB)
1. A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the U.S. must be approved by an IRB before they begin. 2. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants. (NLM) A group of scientists, doctors, clergy, and consumers that reviews and approves the action plan for every clinical trial. There is an Institutional Review Board at every health care facility that does clinical research. Institutional Review Boards are designed to protect the people who take part in a clinical trial. Institutional Review Boards check to see that the trial is well designed, legal, ethical, does not involve unnecessary risks, and includes safeguards for patients. Also called IRB. (NCI) An independent body constituted of medical, scientific, and nonscientific 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 trials, of protocols and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. (ICH E6) Any board, committee, or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the initiation of and conduct periodic review of such research. (21CFR50.3) Intent to treat
Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized even if they never received the treatment. (NLM) The principle that asserts that the effect of a treatment policy can be best assessed by evaluating on the basis of the intention to treat a subject (i.e. the planned treatment regimen) rather than the actual treatment given. It has the consequence that subjects allocated to a treatment group should be followed up, assessed and analysed as members of that group irrespective of their compliance to the planned course of treatment. (ICH E9) Interaction (Qualitative & Quantitative)
The situation in which a treatment contrast (e.g. difference between investigational product and control) is dependent on another factor (e.g. centre). A quantitative interaction refers to the case where the magnitude of the contrast differs at the different levels of the factor, whereas for a qualitative interaction the direction of the contrast differs for at least one level of the factor. (ICH E9) Inter-rater reliability
The property of yielding equivalent results when used by different raters on different occasions. (ICH E9) Interim analysis
Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial. (ICH E9) Interim Clinical Trial/Study Report
A report of intermediate results and their evaluation based on analyses performed during the course of a trial. (ICH E6) Intervention
In medicine, a treatment or action taken to prevent or treat disease, or improve health in other ways. (NCI) Primary interventions being studied: types of interventions are Drug, Gene Transfer, Vaccine, Behavior, Device, or Procedure. (NLM) Intervention group
The group receiving the study agent that is being tested in a clinical trial or clinical study. (NCI) Intervention name
The generic name of the precise intervention being studied. (NLM) Intra-rater reliability
The property of yielding equivalent results when used by the same rater on different occasions. (ICH E9) Investigational
In clinical trials, refers to a drug (including a new drug, dose, combination, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the U.S. Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered investigational in other diseases or conditions. Also called experimental. (NCI) Investigational drug
A substance that has been tested in a laboratory and has gotten approval from the U.S. Food and Drug Administration (FDA) to be tested in people. A drug may be approved by the FDA for use in one disease or condition but be considered investigational in other diseases or conditions. Also called experimental drug. (NCI) 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