Electronic Common Technical Document


Electronic Common Technical Document

The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information.The content is based on the Common Technical Document (CTD) format.

It was developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). To date, over 30,000 eCTD sequences have been submitted to the FDA alonecite web
author=eCTDBlog.com
year=2008
title=FDA, 30,000 eCTDs and Counting!
publisher=eCTDBlog.com
accessdate=2008-07-07
url=http://www.ectdblog.com/2008/07/fda-30000-ectds-and-counting.html
] .

Pharmaceutical point of view

The eCTD has five modules

* 1 Administrative Information and Prescribing Information
* 2 Common Technical Document Summaries
* 3 Quality
* 4 Nonclinical Study Reports
* 5 Clinical Study Reports

A [http://www.fda.gov/cder/regulatory/ersr/5640CTOC-v1.2.pdf full table of contents] could be quite large.

There are two categories of modules:

* Regional module: 1 (different for each region; i.e., country)
* Common modules: 2-5 (common to all the regions)

The CTD only defines the content of the common modules. The contents of the Regional Module 1 is defined by each of the ICH regions (USA, Europe and Japan).

IT point of view

eCTD (data structure)

The eCTD is a message specification for the transfer of files and metadata from a submitter to a receiver. The primary technical components are:

* A high level folder structure (required
* An XML "backbone" file which provides metadata about content files and lifecycle instructions for the receiving system
* An optional lower level folder structure (recommended folder names are provided in Appendix 4 of the eCTD specification)
* Associated DTDs and stylesheets.

Each submission message constitutes one "sequence". A cumulative eCTD consists of one or more sequences. While a single sequence may be viewed with web browser and the ICH stylesheet provided, viewing a cumulative eCTD requires specialized eCTD viewers.

The top part of the directory structure is as follows:

ctd-123456/0000/index.xmlctd-123456/0000/index-md5.txtctd-123456/0000/m1ctd-123456/0000/m2ctd-123456/0000/m3ctd-123456/0000/m4ctd-123456/0000/m5ctd-123456/0000/util

The string ctd-123456/0000 is just an example.

Backbone (header)

This is the file index.xml in the submission sequence number folder.For example:

ctd-123456/0000/index.xml

The purpose of this file is twofold:

* Manage meta-data for the entire submission
* Constitute a comprehensive table of contents and provide corresponding navigation aid.

Stylesheets

A stylesheet should be included that support the presentation and navigation.They must be placed in the directory:

ctd-123456/0000/util/style
See entry 377 in Appendix 4.

DTDs

DTDs must be placed in the directory:

ctd-123456/0000/util/dtd
See entry 371 to 376 in Appendix 4.They must follow a naming convention.

The DTD of the backbone is in Appendix 8.It must be place in the above directory.

Business process (protocol)

The business process to be supported can be described as follows:

Industry <-----> Message <-----> Agency

The lifecycle management is composed at least of:
* Initial submission: should be self-contained.
* Incremental updates: with its sequence number.

Software products

Additionally, a variety of software products exist to facilitate viewing and/or creating eCTD publications. Below is a partial list ordered by company names:

* [http://www.datafarminc.com/scubed.php Datafarm sCubed ]
* [http://www.rosettaectd.com/Rosetta/eCTD_software_products.html DoubleBridge ROSETTA Suite of eCTD Software]
* [http://www.ectdoffice.com eCTD Office (NeeS Creator, NeeS Validator, eCTD Builder)]
* [http://www.extedo.us/products/esubmission/ectdmanager.htm Extedo eCTDmanager]
* [http://www.ectd-gecco.com/software.php Extedo Gecco]
* [http://www.globalsubmit.com/ GlobalSubmit]
* [http://www.i4i.com/eCTD.htm i4i's ALiCE eCTD manager]
* [http://www.ibm.com/lifesciences/score IBM Score]
* [http://www.infotehna.com/products-and-solutions/lifescience/ectdexpert Infotehna]
* [http://www.intrasphere.com Intrasphere PharmaCM]
* [http://www.ectdxpress.com ISI eCTDXPress]
* [http://www.isipublisher.com ISIPublisher]
* [http://www.elevate-nordic.com/Products/LifeDoceCTDsubmission.aspx LifeDoc eCTD submission]
* [http://www.docubridge.com Lorenz DocuBridge]
* [http://www.liquent.com Liquent]
* [http://www.medxview.com/products/ectd/composer.htm MedXView eCTDcomposer]
* [http://www.mission3.com Mission3 OnDemand Product Lifecycle Management]
* [http://www.octagonresearch.com/viewpoint.html Octagon Research Solutions- ViewPoint]
* [http://www.pharmaready.com PharmaReady]
* [http://www.qumas.com/solutions/rd.asp QUMAS R&D Solution]
* [http://www.rosettaectd.com/Rosetta/eCTD_software_products.html ROSETTA pyramid - Submission Tracking and Archiving w/ Bulit-in eCTD Viewer]
* [http://www.samarindrms.co.uk/ Samarind RMS]
* [http://www.sarjen.com/knowledgeNET/index.htm Sarjen knowledgeNET]

ee also

* Clinical trial
* Clinical Data Interchange Standards Consortium
* European Medicines Agency (EMEA)
* Food and Drug Administration (FDA)
* Ministry of Health, Labour and Welfare (Japan).

References

External links

* [http://estri.ich.org/eCTD/eCTD_Specification_v3_2.pdf ICH eCTD Specification V 3.2] (The specification)
* [http://estri.ich.org ICH M2 ESTRI Main]
* [http://www.fda.gov/cder/regulatory/ersr/ectd.htm Electronic Common Technical Document (eCTD)] (FDA)
* [http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm EUDRALEX Volume 2 - Pharmaceutical Legislation : Notice to Applicants] (EU legislation, contains section on eCTD)
* [http://www.it-validation.eu IT Pharma Validation Europe] (Organization: CSV Validation Network)
* [http://www.e-CTD.com eCTD Resource Pages] (Web resources sponsored by a commercial eCTD services provider, but strictly vendor-neutral)


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