eaa777cd_CER_Inventory___CER_Inventory__Category
[Agency] FDA [Project Title] Building FDA CER Clinical Data and Standards Infrastructure, Tools, Skills, and Capacity: Legacy Data Conversion [Institution] SCENPRO, Inc. [Amount] $5,947,450 [Summary] The Food and Drug Administration (FDA) intends to solicit proposals under solicitation number RECOVERY- ARRAOS: 10-223-SOL-00105 for an initiative called “Legacy Data Conversion Services.” Certain legacy study data that currently resides at FDA in a myriad of different formats must be converted into an electronic uniform standard structure to facilitate answering important scientific and regulatory questions of interest to promote the public health. The requirement will provide services to convert legacy study data to a standard format identified by FDA {format to be identified on a case by case basis and may include Clinical Data Interchange Standards Consortium (CDISC; www.CDISC.org) Study Data Tabulation Model (SDTM), Standard for Exchange of Nonclinical Data (SEND), Analysis Dataset Model (ADaM), and the CDISC-HL7 (Health Level 7; www.HL7.org) standards}. The contractor shall work with FDA to harmonize variable names and terminology as needed to allow analysis across multiple studies. The requirement will also support the advancement of current standards and support the development of new standardized values for domain data by ensuring alignment to the appropriate standard development organization (SDO; e.g. CDISC, HL7). [Completion/ Closing Date] 09/17/2010 [Link] link [Category] 
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