Tuesday, February 16, 2010

Preparing a CTD, eCTD Project Planner for your Clinical Submission

In preparing a CTD, eCTD Project Planner for your next Clinical Submission, pharma companies, submission team members, project leaders, managers, regulators and planners must include and integrate communication, correspondence, Q&A, End of Phase 2 Briefing Document discussions, meeting minutes, agreements and commitments, Beginning of Final Marketing Image (FMI) Phase 3 Briefing Document discussions, meeting minutes, agreements and commitments and records of all teleconferences past and current. Communication and resulting deliverables with FDA, now become required regulatory components of the pharma's CTD, eCTD TOC (Table of Contents) and Backbone and must be completed with quality and submitted at the time of filing. If the filing is not complete with FDA requirements as discussed and agreed to with pharma - a RTF, a Refusal to File will be issued when received by FDA. Communications can include but are not limited to CTD, eCTD:

  • content
  • clinical studies
  • statistical analyses
  • file naming conventions
  • navigational QC process
  • folder specifications
  • module numbering (2.7.1, 2.7.2,, conventions
  • module numbering granularity
  • how to present AEs of interest
  • hyperlinking conventions
  • CDISC versions
  • WHO dictionary versions
  • MedDRA versions
  • FDA Guidelines and Guidances at the time of filing
  • how to handle inter-module and intra-module dependencies
  • and otherwise.

It is wise to begin the process of Project Planner Preparation by creating a "generic" project planner and then "customize" the planner in accordance with FDA agreements.

QC all components of the CTD, eCTD clinical submission including hyperlinks, FDA correspondence, module numbering and otherwise to ensure quality, consistency and accurate navigational direction. Navigational QC is an activity that not only "checks" to ensure the accuracy and integrity of your hyperlinks from data to supporting source documents but ensures that the link is "active" and "live" (blue and not black print) when the dossier is submitted to FDA on filing.

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