Page 57 - Terminology-Clinical-Research

that have died. Specific design elements (e.g., crossover, parallel, dose-
escalation).
Stem: The prompt, question, or instruction in a PRO item.
Study design rationale: Reason for choosing the particular
Stochastic: Involving a random variable; involving chance study design.
or probability.
Study design schematic: Schematic diagram (not tabular)
Stopping rules: A statistical criterion that, when met of study design, procedures, and stages. (e.g., ICH E3
by the accumulating data, indicates that the trial can or Annexes IIIa and IIIb).
should be stopped early to avoid putting participants at risk
unnecessarily or because the intervention effect is so great Study end date: The date when all study subjects have
that further data collection is unnecessary. completed the study and that all clinical trial sites have
been closed.
Stratification: The process by which groups are separated
into mutually exclusive subgroups of the population Study endpoint: An outcome used to judge the safety or
that share a characteristic, such as age group, sex, or effectiveness of a treatment.
socioeconomic status. It is possible to compare these
different strata to try and see if the effects of a treatment Study initiation date: Date and time of first subject
differ between the subgroups. enrollment into a study, as verifiable by a convention that is
consistent with authoritative regulatory criteria.
Structured data: Structured health record information
is divided into discrete fields, and may be enumerated, Study population: Characteristics of subjects that are
numeric, or codified. Examples of structured health eligible to participate in the clinical trial, e.g., adult males
information include: patient address (non-codified, but and females, children, etc.
discrete field); diastolic blood pressure (numeric); coded Study protocol: See Protocol.
result observation; coded diagnosis; patient risk assessment
questionnaire with multiple-choice answers. Context may Study record: An entry on ClinicalTrials.gov that contains
determine whether or not data are unstructured, e.g., a summary protocol information about a clinical study,
progress note might be standardized and structured in some such as Recruitment status; Eligibility criteria; contact
EHR-S (e.g., Subjective/Objective/ Assessment/Plan) but information; and, in some cases, summary results. Each
unstructured in others. study record is assigned a ClinicalTrials.gov Identifier
(NCT Number).
Structured product label (SPL): The Structured Product
Labeling (SPL) specification is an HL7 ANSI approved Study start date: The date on which the enrollment of
document markup standard that specifies the structure and participants for a clinical study began.
semantics for the exchange of product information.
Study start: The formal recognition of the beginning of a
Study completion date: The date on which the final data clinical trial that is referred to in the clinical study report.
for a clinical study were collected because the last study
participant made the final visit to the study location (that is, Study treatment: See Investigational intervention.
“last subject, last visit”). The “estimated study completion
date” is the date that the researchers think will be the Study type: Describes the nature of a clinical study. Study
completion date for the study. Types include Interventional studies (or clinical trials),
Observational studies, and Expanded access.
Study coordinator: See Clinical research coordinator.
Study variable: A term used in trial design to denote a
Study description: Representation of key elements of variable to be captured on the CRF.
study (e.g., control, blinding, gender, dose, indication,
configuration). Study: See Clinical trial.

Study design: Plan for the precise procedure to be Subgroup analysis: An analysis in which the intervention
followed in a clinical trial, including planned and actual effect is evaluated in a defined subset of the participants
timing of events, choice of control group, method of in a trial, or in complementary subsets, such as by sex or
allocating treatments, blinding methods; assigns a subject in age categories. Trial sizes are generally too small for
to pass through one or more epochs in the course of a trial. subgroup analyses to have adequate statistical power.

TERMINOLOGY CLINICAL RESEARCH 57