FDA Seeks Comment on Submissions Template, Emphasizes Importance of eData Integrity

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The U.S. Food and Drug Administration (FDA) is seeking comment from drug developers and other stakeholders regarding whether to recommend, with or without suggested modifications, a proposed Analysis Data Reviewer’s Guide (ADRG) template for regulatory submissions.

It’s part of FDA’s ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, nonprofit consortium addressing computational science issues. A PhUSE working group developed the PhUSE ADRG template.

Comments are due within 60 days of the request that was published in the Federal Register on November 8.

Meantime, an agency official recently affirmed the importance of eData integrity. Warning industry professionals not to be “sanguine,” Doug Stearn, JD, in the Office of Enforcement and Import Operations, reminded that data integrity problems do not necessarily involve criminal acts, many people, easy-to-detect issues, or easy-to-fix challenges.

“Such problems can be extremely damaging,” Stearn added.

Be aware that the increasingly vigilant FDA is on the lookout for so-called “unofficial” data integrity systems. Characteristics of those might include:

  • Removal of defective units from the production line without documentation
  • Use of outside batches to blend and “create” batches meeting specification
  • Evidence of deletions overrides in computer systems
  • Raw data and results created outside quality reporting systems (e.g., testing data solely on a flash drive)

FDA is also not going to be fooled by questionable documentation. Stearn provided a few examples:

  • False documentation of job orders, preventative maintenance, and equipment cleaning records
  • Lab documents that fail to indicate known conditions (e.g., mold growth)
  • Pre-recorded final batch quantities documented even before a batch had been weighed

Author: Michael Causey