ICH Publishes Updates to eCTD Specification

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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:

eCTD News

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 🙂 !

Author: GS

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