Category: S

Subject

“1. An individual (either a healthy volunteer or a patient volunteer) whose reactions or responses to certain interventions are evaluated during a clinical trial. May

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Subinvestigator

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to

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Study Coordinator

Person who handles most of the administrative responsibilities of a clinical trial on behalf of a site investigator, acts as liaison between investigative site and

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Single-Blind Research Design

A study in which one party, either the investigator or participant, is unaware of what medication or intervention the participant is taking; also called single-masked

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Screening

A process of active evaluation of potential participants for enrollment in a trial. After a patient is recruited, screening occurs during the enrollment period to

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SAS Transport Files

The SAS Version 5 (V5) transport file format is an open standard developed by SAS to support data transfers between systems, especially those running different

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SAS

SAS (previously “Statistical Analysis System”) is a statistical software suite developed by SAS Institute for data management, advanced analytics, multivariate analysis, business intelligence, criminal investigation,[2]

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Supplement

[FDA] A request to FDA to approve a change to an approved license application. See definitions for individual types of supplements. Source: SOPP 8401.2: Administrative

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Submission

A single set of information and/or documents supplied by the applicant as a part of, or the complete, Application

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Subject Profiles

Subject profiles are displays of study data of various modalities collected for an individual subject and organized by time. Source: Study Data Specifications (FDA)

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Study Data Tabulation Model (SDTM)

SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing;

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Statistical Analysis System (SAS)

SAS is a statistical software suite developed by SAS Institute for data management, advanced analytics, multivariate analysis, business intelligence, criminal investigation, and predictive analytics. SAS

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Sponsor

ICH: An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. According to US 21 CFR

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Sequence Number

The unque four digit number associated with an eCTD sequence, normally beginning with 0000 for the first sequence in an application.

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Sequence

A single set of information and / or electronic documents submitted at one particular time by the applicant as a part of, or the complete

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Signal Detection

Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from

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