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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