Information on new Technical Rejection Criteria (FDA) on Study Data

By 27. January 2017Blog

As one of the last actions in 2016 (effective December 17, 2016) the FDA enforced some new criteria that will allow them to reject an eCTD submission if there is non-compliance with key study data requirements.

FDA notes in their guidance “The standards apply to the following types of submissions to CDER and CBER:

  • NDAs, ANDAs, BLAs, and all subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect.
  • Commercial INDs (for products that are intended to be distributed commercially).”

There are different severities for these problems.

High severity:

  • Demographic dataset (DM) and the define.xml must be submitted in Module 4 for nonclinical data; DM dataset,
    the subject-level analysis dataset (ADSL) and define.xml must be submitted in Module 5 for clinical data
  • Trial Summary (TS) dataset must be present for each study in eCTD section 4.2 and 5.3

Medium severity:

  • Correct STF file-tags must be used for all standardized datasets in section 4.2 and 5.3
    • Analysis-dataset-adam
    • Data-tabulations-dataset-sdtm
    • Data-tabulations-dataset-send
  • For each study in eCTD section 4.2 and section 5.3, no more than one dataset of the same name should be
    submitted as new

Some key information about this:

  • Clinical and nonclinical trials that will be reviewed by CDER/CBER must use the standards in the FDA Data Standards Catalog
  • FDA will validate submissions upon receipt and will assess conformance to required study data standards
  • A technical rejection notice will be sent if the submission fails validation
  • Customers must adhere to the Study Data Technical Conformance Guide when preparing submission for FDA review
  • FDA will provide 30 days’ notice on the FDA eCTD Website prior to the validation criteria being effective
Jim Nichols

Author Jim Nichols

Jim is the vice president for Life Sciences in North America. He has nearly 20 years of experience with compliant software solutions for regulated processes. Jim has worked in senior management positions at Liquent, Thomson Reuters, ePharmaSolutions and DitaExchange. Jim has a Bachelor of Science degree in Mathematics from the Pennsylvania State University.

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