Page 59 - Terminology-Clinical-Research

is correctly exchanged between two systems according Terminated: The clinical study has stopped recruiting
to structured rules whether or not sensible meaning is or enrolling participants early and will not start again.
preserved. Participants are no longer being examined or treated. A type
of Recruitment status.
Synthesis: Synthesis, in this context, means the
contextualization and integration of research findings Therapeutic intervention: See Intervention.
of individual research studies within the larger body of
knowledge on the topic. A synthesis must be reproducible Time frame, Outcome measure: The points in time at
and transparent in its methods, using quantitative and/or which an Outcome Measure is assessed. These times are
qualitative methods. It could take the form of a systematic planned before the clinical study starts and are listed in the
review, follow the methods developed by the Cochrane protocol.
Collaboration, result from a consensus conference or expert Time to progression (TTP): TTP is the time from
panel or synthesize qualitative or quantitative results.
Realist syntheses, narrative syntheses, meta-analyses, meta- randomization until tumor progression, not including
syntheses and practice guidelines are all forms of synthesis. death. This is different from PFS (Progression free
survival) which is the time from randomization until tumor
progression or death.

Tissue engineered product: A product that contains or
T consists of engineered cells or tissues, is presented as

having properties for, or is used in or administered to
human beings with a view to regenerating, repairing or
replacing a human tissue.
Table of roles and responsibilities: A cumulative record
documenting operational access and authorizations of study Title acronym: The acronym or initials used to identify a
personnel to electronic systems used in eClinical trials. clinical study, if provided. For example, the title acronym
for the Women’s Health Initiative is “WHI.”
Tabulation dataset: A dataset structured in a tabular
format. Note: The CDISC Study Data Tabulation Model Title of the trial for lay people: Title of the clinical trial
(SDTM) defines standards for tabulation datasets that fulfill in non-technical terms, suitable for comprehension by
FDA requirements for submitting clinical trial data. individuals without medical/pharmaceutical training.
Token: Physical key that provides access to a secure
Target enrollment: The number of subjects in a class
or group (including the total for the entire trial) intended electronic system or location.
to be enrolled in a trial to reach the planned sample size. Toxicity: A treatment-related adverse effect that may be
Target enrollments are set so that statistical and scientific detrimental to the recipient’s health. The level of toxicity
objectives of a trial will have a likelihood of being met as associated with a treatment will vary depending on the
determined by agreement, algorithm, or other specified attributes of the treatment itself and the condition the drug
process. is being used to treat.

Target study population: Demographic and health Trade name: Name of the MA holder of the actual IMP
condition of the population to be included in a clinical used in the member state concerned by the application.
study.
Trainee: an individual who is enhancing their research
Technology provider: A person, company, or other entity skills through actual involvement in research and who
who develops, produces, and sells software applications works under the formal supervision of an independent
and/or hardware for use in conducting clinical trials and/ researcher; or an independent researcher who has taken
or in analyzing clinical trial data and or submitting clinical a leave of absence from their academic or research
trial information for regulatory approval. Synonym: vendor. position. For example: 1. an undergraduate student

engaged in research at an academic institution; 2. a
Term: One or more words designating something. Note: In
a controlled vocabulary, terms are considered to refer to an graduate student enrolled in a graduate course of study
underlying concept having a single meaning. Concepts may at an academic institution; 3. a postdoctoral fellow (post-
be linked to several synonymous terms. PhD) at a academic or research institution; 4. a post-health
professional degree fellow (e.g., nursing, physiotherapy,

TERMINOLOGY CLINICAL RESEARCH 59