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Archive for September, 2008
ICH Publishes Updates to eCTD Specification
posted by Kathie Clark @ 2:37 AM
Tuesday, September 16, 2008
ICH has published a new eCTD specification (version 3.2.2) and STF specification (v2.6.1), as promised some time ago. This was done with little fanfare - the announcement and links to the documents can be seen at:
For those of you who monitor What’s New on the ICH website? - the updates did not merit a mention there.
The changes resulted from a June meeting, the documents are dated July 2008 and were published on the ICH web site at the end of August.
Only the narrative portion of the document was changed. The DTD and stylesheet have remained unchanged. (In addition, the “valid-values.xml” file has been updated to change file tag “randomisations-scheme” to “randomisation-scheme”).
Changes to the spec are mainly clarifications and items that have been tracked in the Q&A Document (updated version 1.15.1 has been posted), so there really shouldn’t be anything alarming… For the STF document, the cumulative STF approach has been removed (as FDA does not allow it) and other minor updates made.
One nice thing is that the PDFs of these documents are properly bookmarked in Acrobat 
!
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Regulated Product Submissions (RPS) now has a Wiki (or more accurately, it’s part of the overall HL7 Wiki).
To get there, go to Main Page HL7 Wiki. You will have to log in, but you can use the following credentials for read only access:
user name: wiki
password: wikiwiki
(You must create a user name and password if you want to contribute.)
Once you get there, click on the Regulated Product Submissions link in the Projects category.
There is not much in the main area, but following the RPS R2 Project link at that point will give you access to write-ups on Scope and Domain Analysis, as well as a link to business scenarios. Look for information and updates to be posted fairly often.
A little while ago, a client asked me about referencing documents submitted in one application from another application. Her question was in the context of an IND and an NDA, both submitted in eCTD format - did she have to re-submit documents in her NDA that had already been submitted in her IND?
The ICH guidance is basically silent on this subject, although the structure does not specifically prohibit any valid relative link. EMEA has stated that it is not allowed - in “EU Region Question and Answer and Specification Change Request Document”, see question 13:
“In the EU it is possible to refer to a file located in the same sequence or any previous sequence of the same eCTD. It is not possible to refer to other eCTDs.”
If you think about it a little, it requires each agency to maintain a specific set of folders in order for the links to work, and for the sponsor to understand what that structure is.
For example, if the agency stores eCTDs in a known folder path like this:
then I could provide a relative file path from my “NDA” 222222 back to files in my “IND” 111111. But if the agency does not maintain that exact folder structure, my links will break.
Gary Gensinger of FDA has said in several presentations that FDA will accept references to documents in other applications.
In order to do this, your publishing tool must be able to handle this scenario. A leaf must exist in your new application (you cannot reference leafs from other applications, only content files). You will need to know:
Access in through the hlink:xref element, and the operation attribute is NEW.
Gary provided the following example:
With the following commentary:
You want to reference a leaf submitted in 0000 of your IND 012345 for NDA282166, sequence 0000 - Your file is named study-report.pdf in 5.3.5.2. Using the following relative path will allow you to reference the study report:
../../IND012345/0000/m5/5352/study-report.pdf
../ gets you out of the 0000 submission in NDA 282166
Adding ../ gets you out of the NDA 282166
Adding IND012345/0000/m5/5352 gets you to your files location
What I haven’t heard is how many people are taking FDA up on this offer.
By the way, the RPS specification will be designed to allow cross application referencing from the start, and will not reply on a relative folder path.