ACORI | Dictionary: $I

Immune-related Adverse Events

Immune-related adverse events are a unique group of side effects of immunotherapy treatments for cancer that resemble autoimmune responses. Immune-related adverse events can affect almost every organ of the body. However, they are most common in the skin, gastrointestinal tract, lung, and endocrine, musculoskeletal, and other systems.

Inclusion/Exclusion Criteria

Inclusion/exclusion criteria are rules established by the clinical study design that specify who can and who cannot participate in a clinical study, These criteria are designed so as to ensure the health and safety of participants and also that enrolled participants have the characteristics that will enable investigators to maximize the quality and utility of the results of the clinical study.

Independent Ethics Committee (IEC)

An independent ethics committee is a group of people who review, approve, and monitor the rules, regulations, plans, and procedures of a clinical study. Their role is to protect the rights and welfare of people participating in a study. The group typically includes people with varying backgrounds, including a community member, to make sure that research activities conducted by an organization are completely, adequately, and fairly reviewed.

Indication

An indication is a health problem or disease that is identified as likely to be benefited by a therapy being evaluated in clinical study. (CDISC)

Individual Dose

An individual dose is the amount of a medicine/medicine administered in a single dose at a point in time. It is usually expressed as a weight, volume, or a number of items administered.

Industry-sponsored Trial

Industry-sponsored trials are clinical studies that are paid for by an industrial organization that has contracted with an investigator or faculty member. An example of an industrial sponsor is a medical device manufacturer or a pharmaceutical company. In industry-sponsored studies, the investigational new medicine/device application is held by the industrial sponsor.

Informed Consent

Informed consent explains the risks and potential benefits associated with a clinical study before someone decides whether to participate. This is the process by which a participant (or legal guardian) voluntarily confirms his/her willingness to participate in a particular study (after learning about all aspects of the study relevant to his/her decision to take part). Informed consent is usually documented by means of a written, signed, and dated informed consent form, which has been approved by an Institutional Review Board, Independent Ethics Committee, or Human Subjects Protection Review Board. (NIH)

Informed Consent Form

An informed consent form is a document that describes the rights of a clinical study participant and provides details about the clinical study, such as its purpose, duration, required procedures, key contacts, risks, and potential benefits.

Institutional Review Board (IRB)

An institutional review board (IRB) is a group of people who review, approve, and monitor the rules, regulations, plans, and procedures of a clinical study. Their role is to protect the rights and welfare of people participating in a study. The group typically includes people with varying backgrounds (including a community member) to make sure that research activities conducted by an organization are completely, adequately, and fairly reviewed. All human research studies must be reviewed and approved by an IRB.

Intended Use

"Intended use is the specific clinical circumstance or purpose for which a medical product or test is being developed. NOTE: In the regulatory context, this term refers to the ""Statement of Intended Use"""" prepared by the persons legally responsible for the labeling of medical products. (CDISC)"""

Intent to Treat

Intention to treat means that every patient randomized to a clinical study will be included in the primary analysis of the data, even if they dropped out prematurely, were non-compliant to the study treatment, or took the wrong study treatment, This ensures that the analysis population is as complete as possible, and avoids a potential bias due to the exclusion of participants.

Intervention

An intervention is the medicine, device, therapy, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., disease reduction, improved quality of life, etc.) (CDISC)

Intervention Model

An intervention model is the general design of clinical study regarding the strategy for assigning interventions to participants or groups of participants and the analysis of data.

Interventional Clinical Trial

Interventional clinical trial is synonymous with clinical trial and they are both subsets of the term clinical study. An interventional clinical trial tests or evaluates an intervention — medicine, medical device, activity, or procedure — in people. The other main type of clinical study is an observational study. In an observational study, researchers observe participants on their current treatment plan and track health outcomes.

Interventional Product

"An interventional product is the medicine being evaluated in the clinical study; this definition is synonymous with “investigational new medicine”, “investigational medicinal product”, or investigational pharmaceutical product"" (NOV)"""

Investigational Drug

"An interventional drug is the medicine being evaluated in the clinical study; this definition is synonymous with “investigational new medicine”, “investigational medicinal product”, or investigational pharmaceutical product"" (NOV)"""

Investigational New Drug Application

An investigational new drug application is a required request for authorization from the Food and Drug Administration to administer an investigational medicine or biological product to humans. (NIH)

Investigator

An investigator is an individual who conducts a clinical study. It is under the immediate direction of the investigator that participants receive and use the treatment under study. In the event of an investigation conducted by a team of individuals, the investigator is the responsible leader of that team. Related terms include lead investigator, site principal investigator, study chair, study director, and study principal investigator.

Investigator-initiated Study

An investigator-initiated study is a clinical study in which the investigator comes up with the concept of the research, develops the protocol, and serves as both the sponsor and the investigator. In these instances the obligations of the sponsor/investigator include both those of a sponsor and those of an investigator (e.g., creating and coordinating the study and conducting it.)

Clinical Research Terms Glossary

Terms starting with I