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Electronic Common Technical Document (eCTD) Update Jon Clark ICH M2 Deputy Topic Leader January 21, 2003.

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Presentation on theme: "Electronic Common Technical Document (eCTD) Update Jon Clark ICH M2 Deputy Topic Leader January 21, 2003."— Presentation transcript:

1 Electronic Common Technical Document (eCTD) Update Jon Clark ICH M2 Deputy Topic Leader January 21, 2003

2 Overview Description of eCTD Results of September ICH M2 Meeting Interim M2 Work February ICH M2 Agenda FDA eCTD Progress

3 eCTD Description Create and Transport eCTDs Electronic Version of Common Technical Document (CTD) Accommodates CTD 2-5 ICH Modules and Regional Module 1 XML Backbone – Table of Contents Maintained by ICH M2 Expert Working Group (EWG)

4 September M2 Meeting Results eCTD Specification Signed for Step 4 Study Report Specification Posted for Comment – FDA and ICH eCTD Change Control Process Initiated

5 Interim M2 Work Proofed eCTD Specification Post- September –Harmonize with CTD December Videoconference –Define Questions for Q&A Document –Peer Review Change Control Document –Task M2 Sub-Group on Study Reports

6 February ICH M2 Agenda Finalize Change Control Document Reach Agreement on Study Report Implementation Finalize Q&A Document Finalize M2 eCTD Style Sheet Address Change Requests Discuss XML Attributes Updates on Regional Implementation

7 FDA eCTD Progress eCTD Viewer System Project –Version 1 Scheduled for Spring 2003 –Accompanying Guidance FDA Regional Module 1 –Posted on FDA Internet Soon –ICH Partner, PhRMA, piloting sample eCTD Market Research –Review of Commercially Available eCTD Systems

8 Contact Information All Electronic Submissions Questions


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