The Electronic Common Technical Document (eCTD) is a standard used by the FDA (United States Food and Drug Administration), European Agency for the Evaluation of Medicinal Products (EMEA), and other regulatory agencies in order to gain uniformity for a variety of electronic submissions. The IBM® eCTD Viewer is an XML-based tool that assists in the processing of eCTD submissions. This tool allows pharmaceutical companies or regulatory agencies to "view" an eCTD submission that has been prepared using a separate eCTD "builder," such as the IBM Solution for Compliance in a Regulated Environment (SCORE) product. IBM SCORE 5.1.3 can be used to create, edit, and manage eCTD submissions. By using this viewer, the pharmaceutical company can ensure that the submission is readable before sending it to a regulatory agency.

The eCTD Viewer enables the user to

• display and navigate through eCTD structures
• validate that
  • eCTD backbone structure is correct
  • MD5 checksums are correct
  • documents are in the correct folder
  • documents and directory names do not contain illegal characters
  • document and directory names are not too long
  • all files in the submission folder are in the backbone
• downloading of the whole submission as well as any of its parts
• batch printing of documents
• remembering favorite documents across submissions
• searching for documents.

What is the SCORE Configuration Editor?

The IBM Solution for Compliance in a Regulated Environment (SCORE) Configuration Editor is an Eclipse-based utility that can be used to customize the XML configuration files controlling the behavior of the IBM SCORE product. By using this editor, a customer can view and configure the IBM SCORE product in a more efficient manner and reduce the likelihood of introducing configuration errors. This editor provides the following functionality:

• support for handling the configuration files for versions 5.1.1, 5.1.2, 5.1.3, 5.1.3.2 and 6.1.1 of IBM SCORE
• a filtered design pane that provides an easy to understand, graphical representation of the IBM SCORE configuration elements
• the ability to run the cross-file, IBM SCORE validation rules on the configuration files in order to help find errors or invalid configuration scenarios
• easy problem determination: After running the SCORE validation rules, a user can click on an error and be taken directly to the location of the error in the configuration file.
• content assistance, context-sensitive help, and enhanced XML editing capabilities
• the ability to import configuration zip files from an IBM SCORE server for editing and the ability to export a configuration zip file that can be applied to an IBM SCORE repository after editing has been completed.

How does it work?

eCTD Viewer:

The eCTD specification is still an evolving specification: Worldwide agencies are working towards the Module 1 specification, and the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) is making updates to the eCTD specification. The eCTD page of the FDA/Center for Drug Evaluation and Research Web site provides further information.

With eCTD Viewer, the user can build an eCTD using an application specifically designed for that purpose. Such work would normally entail selection of files for the various eCTD modules, rendering of the files to Portable Document Format (PDF)® (as needed), and then packaging of the files into the eCTD "folder" structure.

The IBM eCTD Viewer, which makes use of Internet Explorer 6.x or above and the eCTD DTDs, can be used to examine a submission built according to the ICH specification.

SCORE Configuration Editor:

A customer who has an IBM SCORE installation can export the configuration of an IBM SCORE repository and then import the configuration zip file into the IBM SCORE Configuration Editor, where he can edit the configuration, validate the configuration, and export the configuration zip file from the IBM SCORE Configuration Editor; this file can then be imported back into the IBM SCORE repository.

Daniel Kurtz is a senior consultant at IBM and is currently a member of the IBM Solution for Compliance in a Regulated Environment (SCORE) development team. His focus has been on development activities around IBM SCORE's electronic Common Technical Document (eCTD) functionality. In particular, he has worked on the cross-referencing capabilities and the client-side eCTD Viewer.

Mr. Kurtz received a B.S. in computer science and physics from Dickinson College in Carlisle, Pa., and worked as a document management consultant in the pharmaceutical industry for several years before joining the IBM SCORE development team in IBM""s health care and life sciences area.

Timothy Bishop is a software engineer at IBM and is currently a member of the IBM SCORE development team. His focus has been on development within the configuration and administration areas of the IBM SCORE product. Mr. Bishop lead a summer Speed Team team consisting of two college students, Shenia Thomas and Joshua Bruning, in designing and implementing the initial IBM SCORE Configuration Editor.

Mr. Bishop received a B.A. in computer science from Luther College in Decorah, Ia., and worked in IBM iSeries application development before his current assignment on the IBM SCORE development team.