Glossary of Clinical Research - I

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. It is important to note that 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 when used for an unapproved indication, or when used to gain further information about an approved use. (ICH E6)

• Investigational New Drug

A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for diagnostic purposes. (NLM)

• Investigator

• A researcher in a clinical trial or clinical study. (NCI)
• 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 E6)
• An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. (21CFR50.3)

• Investigator's Brochure

A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects. (ICH E6)