how to create a validated ectd submission based on the new …€¦ · submission based on the new...

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

20.02.2013 EXTEDO Confidential 2

Compiling an eCTD Submission

Compilation of MCC Module 1

Terminology, Metadata, Structure

Compilation of Module 2-5


Compilation of MCC Module 1 – the problem


Compilation of MCC Module 1 – the solution




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!


Electronic Submission Management

eCTDmanager integration into business scenarios


• Import of eCTDs

• Documents

• VDs

• Scan

2

2 Import of structure and content

• eCTD

• paper prints

• VDs

• PDF

• 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


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


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


The Elementary Terminology of eCTDmanager

The Graphical User Interface


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


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


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:


Project

Dossiers

Submissions Submission

Modules

Extensions Linear Listing of

Documents



Live demonstration!


eCTDmanager Story: Your first Submission!

Create Dossier / Submission

Module 1

Add Application Letter

Starting the eCTDmanager


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


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


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)


Open a Submission of a Dossier


Select a submission item in the Project Explorer

and view the Submission content displayed in the Submission Explorer.

Select &

Double Click

View



Live demonstration!


The MCC Regional Part

Module 1

Regional Part MCC (v1.0) – (Business Perspective)


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)


Module 1 MCC Information

Regional Part MCC (v1.0)


Envelope Information Module 1 MCC Information

Module 1: Create GCC Envelope Attributes


The MCC Envelope is created automatically with all required nodes!

All nodes can be filled, supported by wizzards!

Examples…

Module 1: GCC Meta-Data


All folder structure is created

automatically and is ready to be

filled with your documents!


Adding Documents

Drag & Drop a PDF document from Windows Explorer


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


Double-Clicking a Document

activates the Page Viewer

1 Zoom in/out..

2 Fit to

Width/Window ..



Live demonstration!



Compilation of Module 2-5


Goals for this session


At the end of this training session you are well-informed about the

following topics:

eCTD specific sections

Node extensions

Managing Documents

Hyperlinking


eCTD Specific Sections

Module 2 - Module 3

Sections Module 2 and 3 – Business Perspective


Folder & Documents - Specification


The M4 Granularity document

provides the information about

documents and folders.

The Submission Table of Content


Section

Extensible Section

Section Template

Sections


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)


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)


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)


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)


3 Note: eCTDmanager deletes sections and extensions

according the following rules:

Documents added in the actual submission will be deleted


Node Extensions

All Modules

Starting to built up a new ToC Extension (I)


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



Live demonstration!


Managing Documents

Ways of adding Documents


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


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!


Hyperlinking

Ways to create Hyperlinks in eCTDmanager


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


1

broken links

are coloured

red

2

Add the associated studies

To the submission and the

broken links will be repaired

automatically.


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