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CDISC SHARE (Shared Health and Clinical Research Electronic Library) is a metadata repository that supports the development, governance, publishing, and consumption of CDISC standards in human and machine-readable formats.
The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development.
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).
CCOW, or "Clinical Context Object Workgroup," is a standard protocol designed to enable disparate applications to share user context and patient context in real-time, and at the user-interface level. CCOW implementations typically require a CCOW vault system to manage user security between applications.
As wildfires burned across Los Angeles County, burning more than 12,000 structures, many of them homes, two mothers launched a grassroots project to reunite displaced children with their beloved ...
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
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SYDNEY (Reuters) -Asian shares dithered and the dollar edged higher on Monday after U.S. President Donald Trump warned more tariffs were imminent including on steel and aluminium, an inflationary ...