The Case for Tracking Regulatory Submissions

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Tracking each document from start to finish is an important part of the submission process. Regulatory submission teams often create a content plan that identifies submission components, content owners and contributors.

The Submission Tracker assigns key dates to deliverables, for example, when a deliverable will be provided for publishing and when certain tasks related to that deliverable must be completed to in order to promote it to submission ready. The tracker is used to determine if submission content is being provided according to schedule and if publishers are completing tasks on time.

A Submission Tracker identifies:

  • Each document of a submission according to the approved stakeholder content plan
  • Placement of each document within a submission
  • Other pertinent information including
  • Leaf titles
  • Page count
  • Text based on scanned documents
  • Lifecycle of documents
  • Delivery date for publishing
  • Actual dates received for publishing
  • Scheduled date for publishing completion and publishing status

A defining feature of the Submission Tracker is publishing status, which offers ongoing visibility of each document within a submission. Publishing status types include:

  • Document Not Received
  • Document in PDF Publishing
  • Document in Submission Publishing
  • Document in Submission Publishing Quality Check
  • Document Available for Stakeholder Review
  • Stakeholder Approval

Working without a Submission Tracker creates gaps in the business process. Failing to account for such gaps, such as not identifying last-minute documents when establishing a content plan, can cause delay. Without a Submission Tracker to monitor the full content of a submission pertinent documentation can easily be missed and excluded.

Editor’s Note: Maryanne Loscalzo is a Submission Coordinator for GlobalSubmit. She has more than a dozen years of experience in electronic regulatory submission (eCTD and NeeS) publishing to various agencies including the FDA, Health Canada and EMA. Prior to joining GlobalSubmit, she represented both Clinical and Regulatory Operations in the implementation of the Trial Master File Document Management System (FirstDocs) and the upgrade to Global Electronic Library/Submission Build software (NextDocs and eCTD Xpress). 

Author: Maryanne Loscalzo

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