how to create a validated ectd submission based on the new …€¦ · submission based on the new...
TRANSCRIPT
How to create a validated eCTD
submission based on the new
guidelines and specification -
Part 1 supported by eCTDmanager
Schei Dattner Director Sales
Dr. Gerhard Neurauter Director Regulatory Competence Center
14/15. February 2013
Creating an eCTD submission for MCC
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Compiling an eCTD Submission
Compilation of MCC Module 1
Terminology, Metadata, Structure
Compilation of Module 2-5
Terminology, Metadata, Structure
Creating an eCTD submission for MCC
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Compilation of MCC Module 1
Terminology, Metadata, Structure
Compilation of MCC Module 1 – the problem
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Compilation of MCC Module 1 – the solution
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Compilation of MCC Module 1
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At the end of this training session you are well-informed about the following
topics:
Electronic Submission Management & the eCTD Background
The elementary terminology of eCTDmanager
The eCTDmanager environment & GUI
eCTDmanager Story 1: your first Electronic Submission!
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Electronic Submission Management
eCTDmanager integration into business scenarios
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• Import of eCTDs
• Documents
• VDs
• Scan
2
2 Import of structure and content
• eCTD
• paper prints
• VDs
• print streams
• various reports
3
3 Export and Publishing capabilities
Post Approval Maintenance/ Lifecycle Management 4
Using eCTDmanager for Post
Approval Maintenance tasks
4
eCTDmanager core functionality 1
1
The electronic Common Technical Documentation
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1.0 Regional Administrative Information
1.1 ToC of Module 1 or overall ToC,
including Module 1
2.1 ToC of the CTD (Mod 2,3,4,5)
2.2 Introduction
2.3 Quality Overall Summary
2.4 Non clinical Overview
2.5 Clinical Overview
2.7 Clinical Summary
2.6 Non clinical Written and
Tabulated Summaries Module 3 Module 4 Module 5
2.1
2.2
2.3
2.4 2.5
2.6 2.7
1.0
Quality Non clinical
Study Reports
Clinical
Study Reports
Module 2
Module 1
The eCTD – Regional Differences in M2 – M5
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Module 2
Summaries
Module 3
Quality
Module 4
Nonclinical
Study Reports
Module 5
Clinical Study
Reports
Module 1
Regional Admin
Japanese
Language
ISS/ISE
STF
Node
Extensions
Dataset
Folders
Tab List
Trial Sub.
Case Report
Forms
2.3.R
3.2.R
Slide provided by courtesy of Harv Martens
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The Elementary Terminology of eCTDmanager
The Graphical User Interface
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Menubar
Project
Explorer
Document
Explorer
Toolbar
Tool-tab …
Submission
Explorer
eCTDmanager does not have a „Save” button!
All changes are stored immediately!
Document
Viewer
Project / Dossier / Submission
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Project: The Project is the root of the Project Explorer
Project
Dossier
Submission
Dossier: There may be more than one Dossier in a Project
Submission: Submissions are ordered by Submission Numbers (0000 etc.)
Submission
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Collection of Documents is submitted to the regulatory authority to get application rights.
Has an organized structure, displayed in the predefined Table of Content (TOC) of the Submission Explorer.
Its TOC consists of chapters and subchapters as well as user defined extensions, sub-extensions and documents.
Submission
Document
Module
Different Levels – Different Explorers:
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Project
Dossiers
Submissions Submission
Modules
Extensions Linear Listing of
Documents
Compilation of MCC Module 1
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Live demonstration!
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eCTDmanager Story: Your first Submission!
Create Dossier / Submission
Module 1
Add Application Letter
Starting the eCTDmanager
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1a
1b
2
Double-click the eCTDmanager icon on your desktop
Select the eCTDmanager
entry in your start menu
Enter your login name
and password
3 eCTDmanager will be started
Create a New Dossier
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2
3
Activate in the context menu „New Dossier“ or
choose in the menu Dossier „New Dossier“
Enter the „Dossier Name“ and press OK.
1 Select the Project
item in the Project View
A new dossier with
submission 0000
is created
New Dossier Settings
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Region
eCTD Version
Initial Submission (Y/N)
1. Enter Dossier Name and Directory of Submission
2. „Check“ Create Initial Submission
3. Choose „eCTD Version 3.2“ in eCTD Version List
4. Choose „MCC: eCTD Version 1.0
How to create a new MCC-Dossier?
Create a New Dossier (Business Perspective)
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Open a Submission of a Dossier
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Select a submission item in the Project Explorer
and view the Submission content displayed in the Submission Explorer.
Select &
Double Click
View
Compilation of MCC Module 1
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Live demonstration!
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The MCC Regional Part
Module 1
Regional Part MCC (v1.0) – (Business Perspective)
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1 Based on the “Swiss Module 1 Specification for eCTD Version 1.1 of 21.05.2010” 2 CTD Module 1, current version
Envelope Information
Regional Part MCC (v1.0) – (Business Perspective)
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Module 1 MCC Information
Regional Part MCC (v1.0)
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Envelope Information Module 1 MCC Information
Module 1: Create GCC Envelope Attributes
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The MCC Envelope is created automatically with all required nodes!
All nodes can be filled, supported by wizzards!
Examples…
Module 1: GCC Meta-Data
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All folder structure is created
automatically and is ready to be
filled with your documents!
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Adding Documents
Drag & Drop a PDF document from Windows Explorer
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Drag a PDF document (i.e. the “Letter of Application”)
from the windows explorer… 1
…and Drop it into the
submission of eCTDmanager
2
Activating the Viewer, Zooming
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Double-Clicking a Document
activates the Page Viewer
1 Zoom in/out..
2 Fit to
Width/Window ..
Compilation of MCC Module 1
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Live demonstration!
Creating an eCTD submission for MCC
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Compilation of Module 2-5
Terminology, Metadata, Structure
Goals for this session
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At the end of this training session you are well-informed about the
following topics:
eCTD specific sections
Node extensions
Managing Documents
Hyperlinking
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eCTD Specific Sections
Module 2 - Module 3
Sections Module 2 and 3 – Business Perspective
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Folder & Documents - Specification
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The M4 Granularity document
provides the information about
documents and folders.
The Submission Table of Content
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Section
Extensible Section
Section Template
Sections
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Sections: are predefined chapters in the CTD.
Appending of sections is not allowed.
Extensible Sections:
are chapters enabling the
addition of extensions
and subordinated extensions.
Section Templates:
need attributes (e.g. product, manufacturer)
as input to be built up.
may contain a single section or a set of
Sections and Subsections.
Create Specific Section (I)
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1
Complete the attributes questioned by eCTDmanager and press OK 2
Choose a Section Template in the Submission Viewer.
Activate the context menu and select „Create Specific Section“
Create Specific Section (II)
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3 eCTDmanager adds the Specific Section 3.2.S to the TOC,
the Section Template for 3.2.S can be re-used!
Specific Section
Section Template
The content of the Section Template
depends on the CTD Structure
Delete Specific Section (I)
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1 Select a Specific Section in the Submission Viewer and activate the
context menu selecting Delete Specific Section
Confirm to delete the Specific Section 2
Delete Specific Section (II)
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3 Note: eCTDmanager deletes sections and extensions
according the following rules:
Documents added in the actual submission will be deleted
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Node Extensions
All Modules
Starting to built up a new ToC Extension (I)
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1
Insert number and title of the
extension (chapter)
2
Individual chapter number
Title of the chapter
The field NUMBER is freely capable for editing
Choose an Extensible Section
and select Subordinate Extension
Compilation of MCC Module 1
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Live demonstration!
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Managing Documents
Ways of adding Documents
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1 Scanning of paper based
documents
Importing PDF documents 2
Importing WORD documents 3
Drag & Drop from windows
explorer to eCTDmanager 4
Use Template documents like
Interim Documents,
Table of Content Documents …
5
Add Interim Document
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new TOC element „Interim Document“
supports hyperlink creation in an early phase of dossier compilation
enhances parallel working on document completion and dossier compilation
An Interim Document behaves like a document:
title
number
can be used as hyperlink target.
Can be replaced by another document
Hyperlinks will remain!
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Hyperlinking
Ways to create Hyperlinks in eCTDmanager
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1. Create Hyperlinks manually (e.g. m2 summary to m3 quality)
Use Adobe Functionality!
2. Automatic resolution of Hyperlinks (e.g. literature m4.3)
3. Create Hyperlinks from Text (e.g. study documentation)
Search documents for reference keywords,
automatic target detection
Documents
Page number
Bookmarks & Named Destinations
Automatic resolution of externally created hyperlinks
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1
broken links
are coloured
red
2
Add the associated studies
To the submission and the
broken links will be repaired
automatically.
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Create an eCTD Submission – can be so easy!
Danke
Baie Dankie
Ngiyathokoza
Ke a leboha
Ke a leboga
Siyabonga
Inkomu
Ndo livhuwa
Ro livhuwa
Enkosi
Ngiyabonga
Thank You