federal_register: 2016-05958

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2016-05958 Electronic Study Data Submission; Data Standards; Support End Date for Case Report Tabulation Data Definition Specification Version 1.0 Notice The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the end of support for Version 1.0 of Clinical Data Interchange Standards Consortium Case Report Tabulation Data Definition Specification (Define.xml) and an update to the FDA Data Standards Catalog. Use of Define.xml Version 2.0, which has been available since March 2013, is the newer standard supported by FDA. FDA support for Define.xml Version 1.0 will end for studies that start 12 months after March 15, 2017. 2016-03-17 2016 3 https://www.federalregister.gov/documents/2016/03/17/2016-05958/electronic-study-data-submission-data-standards-support-end-date-for-case-report-tabulation-data https://www.govinfo.gov/content/pkg/FR-2016-03-17/pdf/2016-05958.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the end of support for Version 1.0 of Clinical Data Interchange Standards...  

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