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Regulatory Focus™ > News Articles > FDA Dropping Support for Study Data Submission Format

FDA Dropping Support for Study Data Submission Format

Posted 28 January 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) will cease to support an older version of an electronic study data submission format in favor of a newer version of the same standard, it has announced.

The change affects all submissions made to the Centers for Drug Evaluation and Research (CDER), Biologics Evaluation and Research (CBER) or Devices and Radiological Health (CDRH) using the Clinical Data Interchange Standard Consortium (CDISC) Study Tabulation Model (SDTM) Implementation Guide 3.1.1 (SDTM IG 3.1.1).

The standard is now used to support the submission of study data supporting a variety of applications, including new drug applications (NDAs), biologics licensing applications (BLAs), and premarket approval applications (PMAs). The electronic, standardized nature of the submissions allows FDA to more efficiently process and analyze the data compared to paper-based submissions.

The standard, which has been in use since before 2009, will cease to be supported by FDA on 28 January 2015 in favor of the 3.1.2 standard and even more current models. CDISC has already finalized its STDM IG 3.1.3 document, and has called for comments on its 3.1.4 document as well.

These standards are continually evolving, and FDA noted that it is in the habit of "periodically end[ing] support for old standards in favor of newer standards that are better suited to meet FDA data management and review needs."

FDA will also simultaneously be supporting the newer version 3.1.2 standard during the 24-month transition period. That lengthy transition time is meant to accommodate those conducting clinical trials, which can take years to complete. "FDA recognizes the challenges associated with adopting a new standard, particularly because studies are often conducted and study data are standardized months to years before submission to the Agency," it wrote.

Entities requiring extended use of the 3.1.1 standard will be allowed to submit a request for a waiver, available here: (CBER/CDER).


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