Page 31 - Terminology-Clinical-Research

biological drug in a clinical investigation. This includes clinical trials worldwide. The randomly generated, eight-
an application for a biological product used in vitro for digit ISRCTN is unique to a registered trial at current
diagnostic purposes. controlled trials, thereby ensuring that the trial can be
simply and unambiguously tracked throughout its lifecycle
from initial protocol to results publication.

Investigational product: A pharmaceutical form of Item definition: 1. In a questionnaire or form to be
an active ingredient or placebo being tested or used as completed in a clinical trial, the specification of a question
a reference in a clinical trial, including a product with and the specification of the format and semantics of the
a marketing authorization when used or assembled response. 2. Formal specification of the properties of an
(formulated or packaged) in a way different from the item or field of data in an eClinical trial.
approved form, or when used for an unapproved indication,
or when used to gain further information about an approved Item generation: Establishing the content to be covered by
use. the items in a PRO instrument, including generating item
wording, evaluating the completeness of item coverage of
Investigational treatment: An intervention under the concepts of interest, and performing initial assessment
investigation in a clinical study. of clarity and readability. Note: PRO instrument item
generation is potentially incomplete without patient
Investigator/institution: An expression meaning “the involvement.
investigator and/or institution, where required by the
applicable regulatory requirements.” Item group definition: The specification in an eClinical
trial of a collection of items often clinically related to each
Investigator: An individual who actually conducts a other and useful to consider as an ensemble. Note: Item
clinical investigation (i.e., under whose immediate direction
the test article is administered or dispensed to, or used groups are likely to have greater granularity in analysis
datasets using SDTM which can, for example, distinguish
involving a subject, or, in the event of an investigation between different therapy types: study therapy, prior
conducted by a team of individuals, is the responsible therapy, concomitant therapy, protocol forbidden therapies,
leader of that team). Related terms include Site Principal and rescue therapies.
Investigator, Site Sub-Investigator, Study Chair, Study
Director, and Study Principal Investigator. Item: 1. A representation of a clinical variable,
fact, concept, or instruction in a manner suitable for
Investigator (mid-career): Any applicant who, at the time communication, interpretation, or processing by humans or
of registration, has assumed his/her independent academic by automated means. Note: Items are collected together to
position (e.g., faculty appointment) 5-15 years ago.
form item groups. 2. An individual question, statement, or
Investigator (new): A researcher who has held a full time task that is evaluated by the patient to address a particular
research appointment (e.g., faculty appointment providing concept to be measured by a PRO instrument.
eligibility to apply for grants and/or supervise trainees), for IV: Intra-venous.
a period of 0 to 60 months as of a competition deadline.
IVRS: See Interactive Voice Response System.
Investigator (senior): Any applicant who, at the time of
registration, has assumed his/her first independent academic
position (e.g., faculty appointment) more than 15 years ago.

Investigator’s brochure: A compilation of the clinical J
and nonclinical data on the investigational product(s) that
is relevant to the study of the investigational product(s) in
human subjects.
Janus: 1. A logical design conceived by the FDA for a data
IRB: See Institutional Review Board.
warehouse intended to integrate submission data, protocol
Irreversible environmental effect: An effect which is descriptions, and analysis plans from clinical and animal
irreversible within a human lifetime. studies into as an FDA review environment that uses a set
of validated, standards based tools to allow reproducible
ISRCTN number: International Standard Randomised cross-study, data mining, and retrospective comparative
Controlled Trial Number is used for the identification of analysis. 2. The name assigned to a component of the

TERMINOLOGY CLINICAL RESEARCH 31