Page 49 - Terminology-Clinical-Research

Questionnaire: A set of questions or items shown to a terms appear higher on the list.
respondent in order to get answers for research purposes.
Rare disease: A rare disease concerns a restricted number
of patients in the general population and shows evidence
of gravity (because it is life-threatening, invalidating or
R serious and chronic). The limit accepted in Europe is 5
people in 10,000 affected by the disease.
Raw data: Data as originally collected. Distinct from
derived. Raw data includes records of original observations,
Radiopharmaceutical medicinal product: A radioactive measurements, and activities (such as laboratory notes,
pharmaceutical, nuclide, or other chemical used for evaluations, data recorded by automated instruments)
diagnostic or therapeutic purposes. without conclusions or interpretations. Researcher’s records
of subjects/patients, such as patient medical charts, hospital
Random allocation: Assignment of subjects to treatment records, X-rays, and attending physician’s notes. Note:
(or control) groups in an unpredictable way. Note: In These records may or may not accompany an application to
a blinded study, assignment sequences are concealed, a Regulatory Authority, but must be kept in the researcher’s
but available for disclosure in the event a subject has an file.
adverse experience.
RCO: Research Compliance Office.
Random number table: Table of numbers with no
apparent pattern used in the selection of random samples RCRIM: Regulated Clinical Research and Information
for clinical trials. Management, which is a Technical Committee within HL7
(an acronym pronounced “arcrim”).
Random sample: Members of a population selected by a
method designed to ensure that each person in the target Really Simple Syndication: See RSS.
group has an equal chance of selection.
Real-world setting: Studies performed in a ‘real-world’
Randomization: A method based on chance by which setting gather data on cancer, and the effect of different
study participants are assigned to different treatment cancer treatments, from groups (cohorts) of patients that
groups. This minimizes the differences among groups by are visiting and being treated by their own doctor or
equally distributing people with particular characteristics hospital (as compared with clinical trials where patients are
among all the trial arms, thereby avoiding “selection bias.” specifically recruited to take part in a study with a highly
Randomization allows for researchers to comparably test prescribed set of rules).
different treatments in similar groups. Note: Unequal
randomization is used to allocate subjects into groups Recently archived funding opportunity: An archived
at a differential rate; for example, three subjects may be funding opportunity with an application deadline date of
assigned to a treatment group for every one assigned to the May 15, 2007 or later. (These opportunities are located in
control group. CIHR’s Funding Opportunities Database).

Randomized controlled trial (RCT): An experiment Recombinant medicinal product: A drug elaborated using
in which investigators randomly assign eligible human genetic material from various organisms.
research participants or other units of study (e.g.,
classrooms, clinics, playgrounds) into groups to receive Recombinant: A cell or organism in which genetic
or not receive one or more interventions that are being recombination has occurred.
compared. The results are analyzed by comparing outcomes Reconstruction (of a study): For eClinical trials FDA
in the groups. expects archival trial records to support review of the data
as well as the processes used for obtaining and managing
Randomized trial: A study in which participants are
randomly (i.e., by chance) assigned to one of two or more the data so that the trustworthiness of results obtained
treatment arms of a clinical trial. Occasionally placebos are can be evaluated. Note: Reconstruction from records
utilized. should support evaluation of the operation and validity of
computerized systems and the conformance of the systems
Rank: Indicates the order in which studies appear on the to applicable regulations during design and execution of the
Search Results list. The studies most relevant to the search trial as well as during the period of record retention.

TERMINOLOGY CLINICAL RESEARCH 49