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The Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC) defines SDTM. On July 21, 2004, SDTM was selected as the standard specification for submitting tabulation data to the FDA for clinical trials and on July 5, 2011 for nonclinical studies.
Define-XML supports the interchange of dataset metadata for clinical research applications in a machine-readable format. An important use case for Define-XML is to support the submission of clinical trials data in CDISC SDTM, SEND or ADaM [11] format to regulatory authorities. The key metadata components to support submissions are:
Feedback from this pilot and continuous efforts to more closely align this implementation with the SDTM for human clinical trials led to development of SEND 2.3, but without widespread adoption. In 2006, with renewed FDA interest, the industry met to revive SEND and work on a version that, with FDA backing, would cover regulatory submission as ...
The Janus data model is a relational database model, and is based on SDTM as a standard, in terms of many of its basic concepts such as the loading and storing of findings, events, interventions and inclusion data. However, Janus itself is a data warehouse independent of any single clinical trials submission standard.
This is the file index.xml in the submission sequence number folder. For example: ctd-123456/0000/index.xml The purpose of this file is twofold: Manage meta-data for the entire submission; Constitute a comprehensive table of contents and provide corresponding navigation aid.
The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure
Submission management is the art and science of collecting and managing any kind of submissions. Traditionally, submissions were collected offline i.e. in the form of ...
Front page of a floppy disk controller data sheet (1979) A datasheet, data sheet, or spec sheet is a document that summarizes the performance and other characteristics of a product, machine, component (e.g., an electronic component), material, subsystem (e.g., a power supply), or software in sufficient detail that allows a buyer to understand what the product is and a design engineer to ...