Systemized NOmenclature of Medicine – Clinical Terms (SNOMED-CT) is the most precise, comprehensive, standardized, multilingual clinical health terminology product in the world, owned and distributed

[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

The SmPC is a full, official description of a pharmaceutical product, which lists the name of the active substance, its composition, uses, dosages, pharmaceutical forms,

A Task Force of Industry, NCAs, EMA, and SMEs who advise and provide recommendations on planning, development, implementation, and maintenance of IDMP standards in the

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

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

The Study Tagging File (STF) is an xml file that should be provided with the eCTD submission of any file, or group of files belonging

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;

The electronic format by which content of labeling should be submitted to the FDA. SPL utilizes Extensible Markup Language (XML). Source: FDA

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

SEND is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present nonclinical data in a consistent format.

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

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

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