IBM Electronic Common Technical Document Viewer

1. What is the eCTD?

The International Conference on Harmonisation (ICH) M4 Expert Working Group (EWG) has defined the Common Technical Document (CTD). Futher, the ICH M2 EWG has defined a specification for the Electronic Common Technical Document (eCTD).

The eCTD is defined as an interface for industry-to-agency transfer of regulatory information; it also takes into consideration the facilitation of the creation, review, lifecycle management, and archival of the electronic submission. The eCTD also satisfies the criteria that make an electronic submission technically valid. The focus of these criteria is to provide the ability to transfer the registration application electronically from industry to a regulatory authority.

Further information is available at the ICH Web site, FDA Center for Drug Evaluation and Research site, and at eSubmission site.

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2. Why do I need a viewer?

The IBM eCTD viewer allows the user to view submissions built according to the ICH eCTD specification. This is important because many companies have eCTD build utilities that come bundled with a viewer. However, the regulatory agencies, or even partner organizations, may use a separate viewer tool and may not be able to read an eCTD submission. As part of the quality assurance process it is recommended that an organization use a separate viewer product to verify that the built submission can be viewed properly.

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3. Can you provide an overview of the functionality in the IBM eCTD Viewer?

The IBM eCTD Viewer provides the following functionality:

• validation of the backbone structure, calculation of MD5 hashes, checking of the corresponding ones in the backbone, and checking physical catalog names
• supplying of module titles specified in ICH eCTD 3.2, FDA (United States Food and Drug Administration) M1 (Module 1) 1.3, and EU (European Union) M1 1.1
• navigation through the eCTD structure
• downloading of the whole submission as well as any of its parts
• batch printing of documents
• searching for documents that contain specific text in the title or contents within the entire submission of one or more modules.

The following functionality is also provided:

• providing of user access to meta-data
• opening of PDF®, RTF, HTML, XML, and TXT documents in the IBM eCTD Viewer
• opening of PDF, RTF, HTML, XML, and TXT documents in a new window
• obtaining of information about a document without opening it
• support of different document statuses (current, current-appended, replaced)
• provision of search by several criteria simultaneously
• definition of logical operations between criteria during the search
• sorting of search results
• printing and downloading of documents that are the outcome of the search
• easy-to-use display of the search results (easy switching between views: LIST and TREE)
• flexible search by selected modules
• preview of documents before sending them for printing
• creation of favorite documents for subsequent viewing.

In addition, the IBM eCTD viewer can operate in the Windows Dual-Monitor environment with the main eCTD navigation working on one display and a document opened for review on the other display.

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4. Are there any known problems with the Verify process?

Yes:

• A warning will not be presented if a file is located in a subfolder of the recommended folder instead of the recommended folder.
• Files in the util directory are not checked to see if they are listed in the backbone.
• Files with the following extensions are not checked to see if they are listed in the backbone: .xsl, .css, .dtd.

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5. How do I cancel a print job that has already been sent to the Microsoft Print Manager from the viewer?

The user should use the normal mechanism for removing files from the printer queue. Thus, they should select Start -> Printers & Faxes, double-click on the printer where the files have been sent, highlight the file (or files), and then press Delete to remove the jobs from the print queue.

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6. When switching from Snap Shot List View to Life Cycle, the List view is not maintained.

The type of the view is not transferred from panel to panel, but is consistent within each panel. Each panel remembers what the view type was the last time it was opened and applies this type when it is opened again. The tree view is the default type, so when you open the Life Cycle panel the first time, the tree view type will be applied. When you return to the Snap Shot panel, the List view will be re-applied.

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7. The List view appears to be arranged alphabetically, not by module. Is there any way to organize this view by eCTD module?

We are aware of this issue, but we are waiting for further feedback in the alphaWorks forum before making an implementation decision.

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8. In the Favorites, it appears that there is no way of knowing to which submission or folder a favorite belongs.

We are aware of this issue, but we are waiting for further feedback in the alphaWorks forum before making an implementation decision.

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9. The CTOCindex.xml file does not appear when I browse for submissions within the viewer. Is the file present?

The CTOCindex.xml file is not a valid file for the user to browse, so the viewer does not present it. The user should be selecting index.xml files to view.

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10. After opening a submission, I receive the Javascript error Automation server can't create object or the navigation pane is blank. What causes this behavior?

The most likely cause is that your system is missing a required dependency. See the System Requirements section of the User Guide for the required dependencies.

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11. When I open the IBM eCTD Viewer, I receive the following security warning: To help protect your security, Internet Explorer has restricted this file from showing active content that could access your computer. Click here for options.... What should I do?

The IBM eCTD Viewer uses Javascript and ActiveX controls that cause this security warning to be displayed on some systems. You should right-click on the message and select Allow Blocked Content….

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12. How does your viewer display STF files?

STF files are displayed as nodes within tree structure on the navigation pane. The files that are a part of the STF are displayed underneath the STF instead of at the same level as the STF.

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13. I download a list of files to a sequence folder on my PC, but when I use the viewer to "browse," there is no index.xml file to open.

The IBM eCTD Viewer exports a file called CTOCindex.xml, which contains information similar to what would be in the index.xml. Unfortunately, Version 1.5.0 of the viewer does not allow you to select a CTOCindex.xml file for viewing. However, you can work around this problem by entering the following URL into Internet Explorer: Files in the

"<eCTD Viewer install path>resource\tool\Main.htm#ECTD=<CTOCindex.xml path> For example:

C:\Program Files\IBM\IBM eCTD Viewer 1.5\resource\tool\Main.htm#ECTD=C:\Documents and Settings\Administrator\Desktop\nda-123456\0001\CTOCindex.xml

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14. I would like to print the files in the submission according to the modules in which they are located. Is this possible?

At this time, there is no way to print by module. As with #7 above, we are aware of this issue, but are waiting for further feedback in the alphaWorks forum before making an implementation decision.

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15. Are there any known problems with HTML escape sequences?

Yes. In our testing we have found that HTML escape sequences in the XML metadata will result in an index.xml not valid for viewing error.

Since HTML escape sequences are not supported within the XML metadata by the IBM eCTD viewer (as an example, "'"), it is recommended that the user remove any HTML escape sequences from the submission metadata in order to address this problem.

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16. What is IBM Solution for Compliance in a Regulated Environment (SCORE)?

IBM Solution for Compliance in a Regulated Environment (SCORE) is an IBM software product that enables organizations to meet compliance requirements for regulated document management across multiple industries and applications. For more information, please see IBM's Web page for IBM Solution for Compliance in a Regulated Environment.

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17. Are there any known limitations to the IBM SCORE Configuration Editor?

All known limitations are listed in the readme.txt file.

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18. With which versions of IBM SCORE can I use the IBM SCORE Configuration Editor?

Version 5.1.1, 5.1.2, 5.1.3.2, and 6.1.1

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