We are looking to make an eCTD submission for a DMF to the FDA. The documentation for eCTD is high in quantity, but low in quality, and in particular there is a need for a top-level document that brings it all together, I feel, though I think I have now got the basic ideas.
However, there are several things I could not find answers to, and I wondered if anyone here could help.
a. Each leaf element requires an ID. Are we free to assign any arbitrary values, so long as they conform to the rules for XML (unique, start with a letter, etc.)?
b. In the prod-name element in us-regional.xml, for the type attribute, the documents indicate that "chemical" is used for a formula (eg H2O). Is this also used for a chemical name, such as sodium chloride, or would that be an established name?
c. I read somewhere that a US submission must have only one stylesheet, that provided by ICH. However, this does not transform elements in us-regional.xml, as they are under the wrong root element for the XSL file. On the other hand, a document on the FDA web site (Ventura_eCTD.pdf) says (page 19) three stylesheets are needed. I have ectd-2-0.xsl; what are the other two?
d. The Ventura_eCTD.pdf document also says (page 19 again) that all submissions must have three DTDs - ich-ecdt-3-2.dtd and us-regional.dtd, but what other one?)
e. Where does the checksum for us-regional.xml go? I have found nothing to even indicate it is required, but surely it must be?
f. There seems to be nowhere for an overall table of contents to be included (though I appreciate it is required for sections). I assume this is because your software will build one from the XML documents.
g. Somewhere I read that all submissions to the FDA require STFs, but as our DMF has no clinical reports, I assume this is not required.
h. We have a glossary listing abreviations. How do we fit that into the directory structure and XML documents?
A-H
If you need assistance with your specific systems, application or process requirments, I suggest calling a consultant to assist.
Your questions require detailed responses based on a specific process.
Sincerely, John F. Cuspilich, Sr. Consultant RA/QA
FDA.COM
The Auditing Group, Inc.
GMP Publications, Inc. jcuspilich@auditing.com jcuspilich@fda.com
856-596-2333 - 866-GXPNews
Thanks for the comment. I came across a sample submission at at http://www.ectd-gecco.com/, and that answered some questions.
a. IDs are arbitrary, but to conform to XML each must be unique, and start with a letter
c+d. The required three DTDs and three stylesheets can be taken straight out of the sample submission
e. The checksum for us-regional.xml goes in index.xml, you just consider us-regional.xml to be another document, so create a leaf element for it inside the m1 element.
f. The table of contents is not required, opening index.xml or us-regional.xml in IE generates one for you.
