Page 30 - Terminology-Clinical-Research

in which a treatment contrast (e.g., difference between clinical study. Interventions include drugs, medical devices,
investigational product and control) is dependent on procedures, vaccines, and other products that are either
another factor (for example, the center). A quantitative investigational or already available. Interventions can
interaction refers to the case where the magnitude of the also include non-invasive approaches, such as surveys,
contrast differs at the different levels of the factor; for a education, and interviews.
qualitative interaction, the direction of the contrast differs
for at least one level of the factor. Interventional study/Interventional trial (or Clinical
trial): A clinical study in which participants are assigned
Interim analysis: Analysis comparing intervention to receive one or more interventions (or no intervention) so
groups at any time before the formal completion of the that researchers can evaluate the effects of the interventions
trial, usually before recruitment is complete. Note: Often on biomedical or health-related outcomes. The assignments
used with stopping rules so that a trial can be stopped if are determined by the study protocol. Participants
participants are being put at risk unnecessarily. Timing and may receive diagnostic, therapeutic, or other types of
frequency of interim analyses should be specified in the interventions. A study type.
protocol.
In utero: Subjects are unborn infants, still in the womb.
Interim analysis schedule: The time/information points at
which interim analyses are planned. In vitro: (of a biological process) made to occur in
a laboratory vessel or other controlled experimental
Interim clinical trial/study report: A report of environment rather than within a living organism or natural
intermediate results and their evaluation based on planned setting.
analyses performed during the course of a trial.
In vivo: Within the living body (animal/man). A
Internal consistency: Pertaining to data that do not include phenomenon that occurs in real life, as opposed to in the
contradictions. laboratory (“in vitro”).

Intervention model (design): The general design of the Infants and toddlers: Subjects are aged 28 days to less
strategy for assigning interventions to participants in a than 2 years.
clinical study. Types of intervention models include Single
group design, Parallel design, Cross-over design, and INN - Proposed INN: The International Non-proprietary
Factorial design. name for an active substance.
Internet: A global system of computer networks that Interactive Voice Response System: Commonly used for
provides the common TCP IP infrastructure for e mail, the randomisation of treatment and controlling the shipment of
World Wide Web, and other online activities. stock of product.

Internet service provider (ISP): A company that provides International Standard Randomised Controlled Trial
access to the Internet for individuals and organizations. Number: See ISRCTN number.

Interoperability: Ability of two or more systems or Invasive disease free survival (IDFS): The time a patient
components to exchange information and to use the lives (or survives) without return of invasive disease after
information that has been exchanged. adjuvant treatment (a treatment given in addition to the
main form of treatment e.g. chemotherapy given in addition
Inter-rater reliability: The property of scales yielding to surgery, that aims to delay or prevent recurring disease
equivalent results when used by different raters on different by destroying possible remaining cancer cells).
occasions.
Investigational drug: A drug or biological product that
Intervention name: The intervention being studied. is used in a clinical trial but has not been approved by the
Food and Drug Administration (FDA) (the drug is either
Intervention type: The general category of the not available for a doctor to prescribe or is available but has
intervention being studied. Intervention types include Drug, not been approved by FDA for the use being studied).
Device, Biological/Vaccine, and Procedure/Surgery, among
others. Investigational New Drug Application (IND): The
petition through which a drug sponsor requests the FDA
Intervention: A process or action that is the focus of a to allow human testing of a new drug, antibiotic drug, or

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