Thursday, January 22, 2009

Quality Control {QC} of NDA/eCTD Submission Documents

From the desk of Dante.

  • The submission is complete.
  • The regulatory forms filled out.
  • The checklist is being filled in.
  • Timelines are met.
  • While reviewing some late data, you find an error.
  • Panic begins.
  • QC was never performed or even part of the submission plan.
  • What happens next is a horror.

  • QC of submission data and documents is important.
  • QC can vary significantly from company to company.
  • QC and the process and planning should begin at the very beginning with the programming of data, the writing of clinical study reports and as the eCTD pyramid builds into integrated databases, clinical and nonclinical summaries and high level overviews.

It is a daunting task, but a solid QC plan is a must to ensure low error rates and data accuracy and consistency.

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