Page 54 - Terminology-Clinical-Research
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Screening (of sites): Determining the suitability of an semantic refers to the meaning of an element as distinct
investigative site and personnel to participate in a clinical from its syntax. Syntax can change without affecting
trial. semantics.
Screening (of subjects): A process of active consideration Semantic interoperability: The ability of data shared
of potential subjects for enrollment in a trial. by systems to be understood at the level of fully defined
domain concepts.
Screening trials: Trials conducted to detect persons with
early, mild, and asymptomatic disease. Sensitivity analysis: An analysis used to determine how
sensitive the results of a study or systematic review are to
Script: A program or a sequence of instructions that are changes in how it was done. Sensitivity analyses are used to
interpreted or carried out by another program or by a assess how robust the results are in correlation to uncertain
person. decisions or assumptions about the data and the methods
that were used.
Secondary end point(s): Results that are measured at
the end of a study, in addition to the main result (primary Serious adverse event (SAE): An adverse event that
endpoint) to see if a given treatment worked. Secondary results in death, is life-threatening, requires inpatient
endpoints can explore other aspects of the treatment. hospitalization or extends a current hospital stay, results
in an ongoing or significant incapacity or interferes
Secondary objective: See Objective.
substantially with normal life functions, or causes a
Secondary outcome measure: A planned outcome congenital anomaly or birth defect. Medical events that
measure in the protocol that is not as important as the do not result in death, are not life-threatening, or do not
Primary outcome measure but is still of interest in require hospitalization may be considered serious adverse
evaluating the effect of an intervention. Most clinical events if they put the participant in danger or require
studies have more than one Secondary outcome measure. medical or surgical intervention to prevent one of the
results listed above.
Secondary sponsor: Additional individuals, organizations
or other legal persons, if any, that have agreed with the Serious adverse experience: Any experience that suggests
primary sponsor to take on responsibilities of sponsorship. a significant hazard, contra-indication, side effect or
precaution.
Secondary variable: The primary outcome is the outcome
of greatest importance. Data on secondary outcomes are Serious risk: Risk of a serious adverse drug experience.
used to evaluate additional effects of the intervention.
Server: A computer that controls a central repository of
Section 801 of the Food and Drug Administration data, files, and/or applications that can be accessed and/
Amendments Act (FDAAA 801): Section 801 of U.S. or manipulated in some manner by client computers. A file
server hosts files for use by client machines. An application
Public Law 110-85, which was enacted on September 27, server runs programs that may process and display data
2007. It amends Section 402 of the U.S. Public Health exchanged with client machines. After the arrival of the
Service Act to expand the clinical study registry known web, server often refers to software and computers that
as ClinicalTrials.gov and create a clinical study results perform database queries and collect and present timely
database. data to users running browsers or other client applications.
Self-archive: To deposit a digital document in a publicly Severe adverse events or harms: Include adverse events
accessible website, preferably an OAI-compliant Eprint that result in death, require either inpatient hospitalization
Archive. (Source: Budapest declaration, accessed June or the prolongation of hospitalization, are life-threatening,
2009). result in a persistent or significant disability/incapacity or
result in a congenital anomaly/birth defect. Other important
Self-evident change: A data discrepancy that can be easily medical events, based upon appropriate medical judgment,
and obviously resolved on the basis of existing information may also be considered Serious Adverse Events if a trial
on the CRF (e.g., obvious spelling errors or the patient participant’s health is at risk and intervention is required to
is known to be a male and a date of last pregnancy is prevent an outcome mentioned.
provided).
Sex: Phenotypic expression of chromosomal makeup that
Semantic: In the context of a technical specification,
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