Page 58 - Terminology-Clinical-Research

Sub-investigator: Any member of the clinical trial team sponsored surveys) provide aggregate data in the form of
designated and supervised by the investigator at a trial site tables or graphs. One limitation of these prepared aggregate
to perform critical trial-related procedures and/or to make data is that they might not use all the variables of interest to
important trial-related decisions (e.g., associates, residents, the user.
research fellows).
Superiority trial: A trial with the primary objective of
Subject: A person participating in a trial - the subject may showing that the response to the investigational product is
be a patient or a healthy volunteer. superior to a comparative agent (active or placebo control).

Subject data event: A subject visit or other encounter Supervisor: An individual who: 1. is a mentor; and 2.
where subject data are collected, generated, or reviewed. supervises trainee(s); and 3. holds an independent research
appointment in areas of investigation where it is clear that
Subject identification code: A unique identifier assigned the research has direct relevance to health.
by the investigator to each trial subject to protect the
subject’s identity and used in lieu of the subject’s name Supplier: An organization that enters into a contract with
when the investigator reports adverse events and/or other the acquirer for the supply of a system, software product, or
trial-related data. software service under the terms of a contract.

Subjects incapable of giving consent personally: Supporting variables: See Variable.
Subjects who are incapable of giving consent personally
to be enrolled in the trial. For example: minors or mentally Surrogate endpoint: A biomarker or endpoint that is
impaired subjects. intended to substitute for a clinical endpoint. A surrogate
endpoint is expected to predict a clinical endpoint or lack
Subject trial contact: Any activity, anticipated in the study thereof.
protocol, involving a subject and pertaining to collection of
data. Surrogate marker: A measurement of a drug’s biological
activity that substitutes for a clinical endpoint such as death
Subject/trial subject: An individual who participates in or pain relief.
a clinical trial, either as recipient of the investigational
product(s) or as a control. Surrogate variables: A variable that provides an
indirect measurement of effect in situations where direct
Subject-reported outcome (SRO): An outcome reported measurement of clinical effect is not feasible or practical.
directly by a subject in a clinical trial.
Survey: Any means (e.g., questionnaire, diary, interview
Submission model: A set of data standards (including script, group of items) that is used to collect PRO data.
SDTM, ADaM, and define.xml) for representing data that Note: Survey refers to the content of the group of items
are submitted to regulatory authorities to support product and does not necessarily include the training and scoring
marketing applications. documents generally not seen by respondents.

Summary of Product Characteristics (SmPC): This is SUSAR: Suspected Unexpected Serious Adverse
the product information document which is made available Reactions.
to all prescribing physicians in the EU for marketed
products. Suspended: The clinical study has stopped recruiting or
enrolling participants early, but it may start again. A type of
Summary-level or aggregate data: The result of applying Recruitment status.
statistical procedures (e.g., weighting, imputation) and
analyses (e.g., means, regression) to micro-level data sets. Synopsis: Brief overview prepared at the conclusion
Aggregate data provide estimates (e.g., how much aspirin of a study as a routine part of a regulatory submission,
reduces stroke risk) of the true result for the entire target summarizing the study plan and results; includes numerical
population of the study (e.g., for all men with history summary of efficacy and safety results, study objective,
of MI), based on data collected from the participants in criteria for inclusion, methodology, etc.
a study who were sampled from the target population.
Aggregate data can be univariate or multivariate, and can Syntactic: The order, format, content of clinical trial data
describe associations, trends over specific time periods, etc. and/or documents as distinct from their meaning. Note:
Journal articles and some websites (e.g., many federally Syntactic interoperability is achieved when information

58 AlphaScienceLabs.com