Page 60 - Terminology-Clinical-Research

medicine, dentistry) at an academic or research institution. Trial being conducted completely outside of the EEA:
Trial being conducted outside the European Economic
Training award programs: All CIHR-funded Area.
Studentships, Health Professional Student Research
Awards, Master’s Awards, Doctoral Awards, MD/PhD Trial contains a sub-study: A sub-study, or ancillary study,
Studentships, Fellowships, Senior Research Fellowships is a study performed on a subgroup of the subjects included
(Phase 1), Clinician Scientists (Phase 1), including in the clinical trial. For example, a pharmacokinetics or
partnered training opportunities, unless otherwise stated in pharmacogenetics sub-study may include a sample of the
the funding opportunity. patients participating in the clinical trial.

Transcription: Process of transforming dictated or Trial coordinator: See Clinical research coordinator.
otherwise documented information from one storage
medium to another. Note: often refers explicitly to data Trial Design Model: Defines a standard structure for
that is manually transcribed from source docs or measuring representing the planned sequence of events and the
devices to CRFs or to eCRFs. treatment plan of a trial. Note: A component of the SDTM
thatbuilds upon elements, arms epochs, visits; suitable also
Transition rule: A guide that governs the allocation for syntactic interpretation by machines.
of subjects to operational options at a discrete decision
point or branch (e.g., assignment to a particular arm, Trial has a placebo: The clinical trial using placebo - A
discontinuation) within a clinical trial plan. dummy medicine containing no active ingredients; an inert
treatment.
Translation: Converting information from one natural
language to another while preserving meaning. Trial information: Consists of trial research data and trial
materials.
Transmit: To transfer data, usually electronically. Note:
In eClinical investigations data are commonly transmitted Trial is part of a PIP: A study is part of a Paediatric
from subjects to clinical study sites, within or among Investigation Plan.
clinical study sites, contract research organizations, data
management centers, and sponsors, or to regulatory Trial monitoring: Oversight of quality of study conduct
authorities. and statistical interim analysis.
Trial phase: The trial phase (Phase I, II, III or IV).
Treatment effect: An effect attributed to a treatment in
a clinical trial. In most clinical trials the treatment effect Trial registration: Involves the assignment of a unique
of interest is a comparison (or contrast) of two or more identification number; the recording and public release of
treatments. protocol information; as well as the recording and public
release of trial results. Note: WHO regards trial registration
Treatment-emergent adverse event: An event that as the publication of an internationally-agreed set of
emerges during treatment, having been absent pre- information about the design, conduct and administration
treatment, or worsens relative to the pre-treatment state.
of clinical trials. These details are published on a publicly-
Treatment Investigational New Drug (IND): It accessible website managed by a registry conforming to
makes promising new drugs available to desperately ill WHO standards.
participants as early in the drug development process as Trial research data: Summary level or aggregate data
possible. Treatment INDs are made available to participants (this usually gets published as results- see also definition of
before general marketing begins, typically during Phase 3 results), and individual participant or micro-level data (also
studies. To be considered for a treatment IND a participant
cannot be eligible to be in the definitive clinical trials. called raw data).
Trial research materials: Include the protocol, and
Treatment trials: Refers to trials which test new amendments, ethics approval, consent form, information
treatments, new combinations of drugs, or new approaches about financial arrangements, and any data collection
to surgery or radiation therapy.
forms.
Trial being conducted both within and outside the EEA:
Trial being conducted both within and outside the European Trial site: Synonym for investigative site, investigator site,
Economic Area. site, site of the trial, study site.

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