Important Reminder from CDISC: FDA Binding Guidance Goes into Effect Next Month

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Sponsors whose studies start after December 17, 2016 must submit data in FDA-supported formats listed in the FDA Data Standards Catalog.

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The Clinical Data Interchange Standards Consortium (CDISC) would like to remind the clinical research community that the FDA Binding Guidance goes into effect next month. Sponsors whose studies start after December 17, 2016 must submit data in FDA-supported formats listed in the FDA Data Standards Catalog. The current FDA Data Standards Catalog specifies the use of CDISC standards: SDTM, SEND, ADaM and Define-XML as well as Controlled Terminology.

The FDA’s Guidance on Standardized Study Data states . . . "After the publication of this guidance, all studies with a start date 24 months after the publication date must use the appropriate FDA-supported standards, formats, and terminologies specified in the Catalog (see section II.C) for NDA, ANDA, and certain BLA submissions.”

Implementing CDISC standards offers a number of benefits, including fostering efficiency, improving data quality, enhancing innovation, streamlining processes, increasing the ability to share information among systems and organizations, and reducing costs. Additionally, submitting standardized data helps regulatory reviewers receive, process, review, and archive submissions more effectively.

About CDISC - CDISC is a 501(c)(3) global, non-profit charitable organization that develops clinical research data standards to streamline research and enable connections to healthcare. The CDISC suite of standards supports the complete clinical research lifecycle from protocol through analysis and reporting by allowing data to speak the same language, making the most of the valuable information offered by patients participating in research studies around the globe. Implementing CDISC standards from the start of studies enables Smarter Research to Unlock Cures, saving 70-90% start-up time and ~60% overall in time and resources to conduct clinical research.

CDISC is funded through the generous support of over 400 member organizations, as well as through grants, authorized Education courses and CDISC events. To find out more about how to support CDISC, please visit http://www.cdisc.org.

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Ann P. White, Senior Communications Manager
CDISC
+1 (512) 363-5826
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Clinical Data Interchange Standards Consortium (CDISC)
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