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SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). 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. Eventually, all data submissions will be expected to conform to this format. As a result, clinical and nonclinical Data Managers will need to become proficient in the SDTM to prepare submissions and apply the SDTM structures, where appropriate, for operational data management.
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations...
Guangdong Province, Guangzhou, China Tata Institute of Social Sciences (TISS) SDTM Library, Mumbai, India Texas A&M University Libraries, College Station, Texas...
data repository also provides a common data model which is based on the SDTM standard to represent clinical data submitted to regulatory agencies, such...
design). 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...
(either clinical or nonclinical). This information should be provided in the SDTM TS domain when a full TS is indicated. The information should be provided...
Exclusion and Inclusive Policies Centre for Library and Information Management & SDTM Library Jamsetji Tata Centre for Disaster Management Computer Centre Publications...
University Training for students and young engineers / Education. Test of 3-axis SDTM magnetometer Failed; No signal received 21 Jul 2012 H-IIB to ISS 9 May 2013...
2016. InterVisionSoft LLC (2016). "Sailboat Specifications for Catalina 27 SDTM". Sailing Joy. Archived from the original on 28 November 2016. Retrieved...
Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) Standard for Exchange of Non-clinical Data (SEND) JANUS clinical trial data...
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