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(e)CTD and Authoring at Genzyme Presentation for Medical Writer - - PowerPoint PPT Presentation
(e)CTD and Authoring at Genzyme Presentation for Medical Writer - - PowerPoint PPT Presentation
(e)CTD and Authoring at Genzyme Presentation for Medical Writer Groep Nederland 8 December 2005 What CTD and Documents Tools Authoring / Review and RA Operations Some tips on Dos and Don'ts Diagrammatic Representation of
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Module 1 Regional Admin Information 1.1 Submission T of C CTD Table of Contents 2.1 CTD Introduction 2.2 Quality Overall Summary 2.3 Nonclinical Overview 2.1 Clinical Overview 2.5 Nonclinical Written and Tabulated Summaries 2.2 Clinical Summary 2.7 Module 3 Quality 3 3.1 T of C Module 4 Nonclinical Study Reports 4 4.1 T of C Module 5 Clinical Study Reports 5 5.1 T of C
Not part of CTD but part of eCTD CTD Module 2
Diagrammatic Representation of the ICH Common Technical Document
Source: http://www.ich.org/MediaServer.jser?@_ID=554&@_MODE=GLB
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How deep down…
Module 2 2.1 OVERALL CTD TABLE OF CONTENTS OF MODULES 2, 3, 4, AND 5 2.2 INTRODUCTION 2.3 QUALITY OVERALL SUMMARY 2.3.S DRUG SUBSTANCE 2.3.S.1 General Information 2.3.S.2 Manufacture 2.3.S.3 Characterization 2.3.S.4 Control of Drug Substance 2.3.S.5 Reference Standards or Materials 2.3.S.6 Container Closure System 2.3.S.7 Stability 2.3.P DRUG PRODUCT 2.3.P.1 Description and Composition of the Drug Product 2.3.P.2 Pharmaceutical Development 2.3.P.3 Manufacture 2.3.P.4 Control of Excipients 2.3.P.5 Control of Drug Product 2.3.P.6 Reference Standards or Materials 2.3.P.7 Container Closure System 2.3.P.8 Stability
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eCTD Consideration for granularity:
Expected change of the document versus the management of lots of documents.
Directory structure according to eCTD:
m4 41-toc 42-stud-rep 421-pharmacol
Individual documents contain bookmarks, hyperlinks within the individual document and to other documents in the same submission sequence.
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What … CTD and Documents Tools Authoring / Review and RA Operations Some tips on Do’s and Don'ts
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Tools
Shown are all instances where a file has been used.
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Tools (continued)
the Delta view of a submission (Life Cycle Management)
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What … CTD and Documents Tools Authoring / Review and RA Operations Some tips on Do’s and Don'ts
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Pre authoring/ Planning Authoring/ Review Formatting Compile/Publish/ Print Archive QC Management and Tracking Admin CMC Non Clinical Clinical Entire Submission Entire Submission Entire Submission
Submission is complete and out the door A section of Submission arrives In RA Ops (with sign-off)
- Commitment to Agency
- Commitment to Organization
- Product Team is assembled
- Authors and Reviewers
are identified
- Timelines are established
- A component is available for
formatting
Overall Submission Admin CMC Non Clinical Clinical
Interface with (provide templates and instructions) and their output supports
- ur process
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Role of RA Operations and Authors RA Ops: Provides support to authors and reviewers with respect to source summary document formatting, posting for review and version control in the official regulatory project area. Authors: ‘Pre-publish’ tasks like:
Use of Templates, Follow formatting guide, (pre-) cross referencing in blue
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Global Authoring/Review/Formatting Detail Slide #1 – Green Draft
Green Draft v1 working version available in Livelink Review RAOps (US or EU) Provides support to Section Coordinator with respect to both working version and source summary document formatting, posting for review and version control in the official regulatory project area. Document Leader(a) (author/contributor) RA Section Coordinator communicates content requirements to, and compiles content provided from authors and contributors to produce the Green Draft – makes available to reviewers via Livelink. Green Draft v1.1 available in Livelink Review for Roundtable Discussion RA Section Coordinator collates comments and edits provided by primary reviewers to produce an updated Green Draft and summary of issues for discussion/resolution at the 1st Team Roundtable Roundtable Review discussion/resolution of comments and issues identified in the Green Review cycle. Potential need to request additional input/clarification from Document Leaders continue at RA Section Coordinator - next page US Primary Reviewer collects comments, identifies and addresses issues, collates in a single document EU Primary Reviewer collects comments, identifies and addresses issues, collates in a single document Secondary Reviewers Secondary Reviewers RAOps (US) Collects and prepares supportive documentation necessary for inclusion in submissions (i.e., validation reports, qc documents, preclinical study reports, article reprints, etc) including as necessary, scanning, bookmarking and hyperlinking and qc components Ongoing pre-publishing work on source drafts regarding formatting requirements to meet final publishing needs (e and paper). Green Draft v1 source secured in Livelink Project Green Draft v1.1 source secured in Livelink Project
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Global Authoring/Review/Formatting Detail Slide #2 – Yellow Draft
Yellow Draft v1 working version available in Livelink Review RAOps (US or EU) Provides support to Section Coordinator with respect to both working version and source summary document formatting, posting for review and version control in the official regulatory project area. Document Leader(s) (author/contributor) RA Section Coordinator communicates content requirements to, and compiles content provided from authors and contributors to produce the YellowDraft – makes available to reviewers via Livelink. Yellow Draft v1.1 available in Livelink Review for Roundtable Discussion RA Section Coordinator collates comments and edits provided by primary reviewers to produce an updated Yellow Draft and summary of issues for discussion/resolution at the 2nd Team Roundtable Roundtable Review discussion/resolution of comments and issues identified in the Yellow Review cycle continue at RA Section Coordinator - next page US Primary Reviewer collects comments, identifies and addresses issues, collates in a single document EU Primary Reviewer collects comments, identifies and addresses issues, collates in a single document Secondary Reviewers Secondary Reviewers RAOps (US) Collects and prepares supportive documentation necessary for inclusion in submissions (i.e., validation reports, qc documents, preclinical study reports, article reprints, etc) including as necessary, scanning, bookmarking and hyperlinking and qc components Ongoing pre-publishing work on source drafts regarding formatting requirements to meet final publishing needs (e and paper). Yellow Draft v1 source secured in Livelink Project Yellow Draft v1.1 source secured in Livelink Project
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Global Authoring/Review Detail Slide #3 – Red Draft
Red Draft v1 working version available in Livelink Review RAOps (US or EU) Provides support to Section Coordinator with respect to both working version and source summary document formatting, posting for review and version control in the official regulatory project area. Document Leader(s) (author/contributor) RA Section Coordinator communicates content requirements to, and compiles content provided from authors and contributors to produce the Red Draft – makes available to reviewers via Livelink. Red Draft v1.1 available in Livelink Review for Roundtable Discussion RA Section Coordinator collates comments and edits provided by primary reviewers to produce an updated Red Draft and summary of issues for discussion/resolution at the 3rd Team Roundtable Roundtable Review finalization and Team sign-off of content – released for pre-publishing and compilation of final draft intended for senior management review and sign-off continue at Module Coordinator - next page US Primary Reviewer collects comments, identifies and addresses issues, collates in a single document EU Primary Reviewer collects comments, identifies and addresses issues, collates in a single document Secondary Reviewers Secondary Reviewers RAOps (US) Collects and prepares supportive documentation necessary for inclusion in submissions (i.e., validation reports, qc documents, preclinical study reports, article reprints, etc) including as necessary, scanning, bookmarking and hyperlinking and qc components Ongoing pre-publishing work on source drafts regarding formatting requirements to meet final publishing needs (e and paper). Red Draft v1 source secured in Livelink Project Red Draft v1.1 source secured in Livelink Project
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What … CTD and Documents Tools Authoring / Review and RA Operations Some tips on Do’s and Don'ts
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General tips In order to have a good quality PDF to include in an electronic submission or to print on paper: Font: Times New Roman Narrative body text 12 point Headers and footers 10 point Tables not smaller than 10 point. Use 12 or 11 if possible No background shading (also not in tables)! No other colors than black and blue (blue for hyperlinks only)
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General tips (continued)
Content In each module acronyms and abbreviations should be defined the first time they are used. Linking: Cross reference is done to the module, sub module and volume Authors should already indicate the inter-document cross reference to be made, as precisely as possible, in the correct format. The intra – document references should be made by the author (Caption for tables and Figures, cross references)
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MS Word tips (1)
Check authors: Use of general RA-CTD templates No (hard) returns in between headings Narrative text is in “Body text” style Use of headings from the template Referencing within the document Adding headings is only allowed below the level of subheadings. The CTD structure should be preserved. If the lowest heading in the template is 3.2.P.3.5 you can add: 3.2.P.3.5.1 Own sub heading 1 Use as little subheadings as possible!
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MS Word tips (2) Check authors … The document must not include the comments after the final review
This prevents comments turning up in a pdf file or visible in an electronically submitted word file to the rapporteurs.
The document is of a certain style (called ‘Final Mark up’) The document is not protected with a password
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