Page 51 - Terminology-Clinical-Research

submission is successful the regulatory authorities will Reporting (or comparison) group: A grouping of
grant marketing authorization (permission to sell the drug). participants in a clinical study that is used in summarizing
Examples of regulatory authorities include The Food and the data collected during the study. This grouping may be
Drug Administration (FDA) in the U.S. and the European the same as or different from a study arm.
Medicines Agency (EMA) in Europe. Note: In the ICH
GCP guideline the term includes the authorities that review Representative: See Legally acceptable representative.
submitted clinical data and those that conduct inspections. Rescue medication: A quick-relief or fast-acting
These bodies are sometimes referred to as competent
authorities. medication patients in clinical trials may be given besides
the investigational drug or control that can alleviate
Relative survival rate: Ratio of a cancer patient’s chance symptoms due to disease or lack of efficacy of the study
of surviving a given time interval compared with that of an treatment. It acts quickly to stop symptoms, but the effects
average person without cancer of the same age and sex. are not long lasting.
Release time allowance: When included in a funding Research (biomedical): Research with the goal of
opportunity description, is an eligible expense to facilitate understanding normal and abnormal human functioning,
the participation of knowledge users in a research program. at the molecular, cellular, organ system and whole body
Funds are used to compensate the organization of the levels, including development of tools and techniques
knowledge user for his/her time spent engaged in the to be applied for this purpose; developing new therapies
research program. Release time allowance requests will or devices that improve health or the quality of life of
not be considered for the following: 1. individuals with individuals, up to the point where they are tested on human
salaried academic research appointments; 2. the cost of subjects. Studies on human subjects that do not have a
teaching time to allow the individual to engage in research; diagnostic or therapeutic orientation.
3. supplementing or replacing part of the salary of a Research (clinical): Research with the goal of improving
researcher on sabbatical from their main appointment.
the diagnosis, and treatment (including rehabilitation and
Reliability, psychometric: The degree to which a palliation), of disease and injury; and improving the health
psychometric “instrument” is free from random error either and quality of life of individuals as they pass through
by testing the homogeneity of content on multi-item tests normal life stages. Research on, or for the treatment of,
with internal consistency evaluation or testing the degree to patients. A CIHR theme.
which the instrument yields stable scores over time. Note:
Reliability pertains to questions concerning whether an Research (health services): Research with the goal
instrument is accurate, repeatable, and sensitive. Reliability of improving the efficiency and effectiveness of health
professionals and the health care system, through changes
is distinguished from validation, which answers whether to practice and policy. Health services research is a
the instrument (e.g., questionnaire) actually measure multidisciplinary field of scientific investigation that studies
the selected “construct” (latent variable). For example a
balance (scale) is easily understood as a possibly valid how social factors, financing systems, organizational
instrument to measure body weight. Its reliability would structures and processes, health technologies, and personal
behaviours affect access to health care, the quality and cost
be assessed by measuring the sensitivity, repeatability of health care, and, ultimately, Canadians’ health and well-
and accuracy of the balance. The validity of using the being. A CIHR theme.
balance for a particular purpose could then be established
by comparing the measured reliability to the reliability Research administration: Institution officials who provide
required for that purpose. administrative services to researchers, from offices such
as the research grants office, research accounting office or
Removed location countries: Countries that appeared scholarships liaison office, as relevant.
under Listed Location Countries but were removed from
the study record by the data provider. Research associate: A researcher who: 1. has completed
formal training in research in a discipline relevant to health
Repeat rule: Guide for repeating activities specified in
protocol, including such features as the number of cycles research, usually a Masters or PhD; 2. is employed by an
institution; 3. works under the supervision of a Principal
and the criteria for stopping.
Applicant, i.e., they are not independent researchers; 4.
Replacement: The act of enrolling a clinical trial subject to may contribute substantially to the intellectual content of
compensate for the withdrawal of another. the research; 5. may contribute to, but is not ultimately

TERMINOLOGY CLINICAL RESEARCH 51