Comments for The eCTD summit

Comment on Update to Study Tagging File valid-values: What Does It Mean? by News Roundup Part 1: Agency News « The eCTD summit

News Roundup Part 1: Agency News « The eCTD summit — Thu, 12 Aug 2010 15:32:34 +0000

[...] issued a new valid-values.xml for study tagging files see my Blog Post on The eCTD Summit for [...]

Comment on Top FDA Processing Issues with eCTD: A Recent Update by Bookmarks – Collapsed or Expanded? | Ask Cato

Bookmarks – Collapsed or Expanded? | Ask Cato — Tue, 10 Aug 2010 14:02:27 +0000

[...] Top FDA Processing Issues with eCTD: A Recent Update (theectdsummit.com) [...]

Comment on Updated Study Data Specifications and the eCTD Dataset Problem by Kathie Clark

Kathie Clark — Mon, 19 Jul 2010 13:09:15 +0000

Mallikaarjunan, I have been waiting for the ICH to update the valid-values.xml to answer this question - see my latest post for the answer. http://theectdsummit.com/summit/?p=841

Comment on Updated Study Data Specifications and the eCTD Dataset Problem by Update to Study Tagging File valid-values: What Does It Mean? « The eCTD summit

Mon, 19 Jul 2010 13:01:28 +0000

[...] Does It Mean? posted by Kathie Clark @ 6:01 PM Monday, July 19, 2010 As I discussed in my previous post, FDA issued version 1.5.1 of Study Data Specifications in January of 2010. Although the changes [...]

Comment on Updated Study Data Specifications and the eCTD Dataset Problem by mallikaarjunan

mallikaarjunan — Mon, 31 May 2010 10:06:06 +0000

Thanks for this Information. I have a question on this.

For creating sub folders for datasets under analysis and legacy, sdtm under tabulation— what will be the document file tag?

Thanks
Malli

Comment on What is a porp? How RPS XML is different (and scarier) than eCTD by joelfinkle

joelfinkle — Fri, 28 May 2010 13:15:26 +0000

Sorry — hit the enter too soon. What you left out is that the PORP is the top-level XML object in an RPS file, or more exactly,

Comment on What is a porp? How RPS XML is different (and scarier) than eCTD by joelfinkle

joelfinkle — Fri, 28 May 2010 13:13:20 +0000

Kathie,
Nice basics article on RPS’s guts… but still, what’s a PORP?

I’m pretty sure the “RP” stands for Regulated Product… but much of HL7’s naming is pretty opaque.

Comment on Updated Study Data Specifications and the eCTD Dataset Problem by Evan Richardson

Evan Richardson — Mon, 03 May 2010 14:07:52 +0000

Thanks for this information Kathie. I suspect that many of us will go with the 1st and 3rd options you’ve presented. We’ll look to our publishing software vendors to provided updates, and then be forced to go through the re-validation process. In the meantime, we’ll likely need to ask the FDA for a waiver.

Comment on Structuring of Clinical Study Reports: Common Practices, Good Practices by montelevinson

montelevinson — Wed, 28 Apr 2010 23:27:18 +0000

There’s one important caveat to Joel’s comment, above. For granular reports it’s highly advantageous to follow the E3 guidance numbering in section 16 of the CSR, which includes all the appendices

When you submit the CSR, each appendix gets attached to the eCTD backbone as a separate file. Using the E3 numbering in the file name will make it **much** easier to find the correct spot to attach the file in your publishing software.

Putting the section number in the document (in the header, for example) will make it easier to QC the submission.

Whatever you do, don’t change the numbering in section 16. If you don’t have a particular appendix in your study report just skip that number.

Comment on Structuring of Clinical Study Reports: Common Practices, Good Practices by joelfinkle

joelfinkle — Wed, 14 Apr 2010 01:28:12 +0000

While you’re discussing the CSR… my little Public Service Announcement is that you do NOT need to number the sections of the report with the same section numbers as the ICH E2 guidance.

Really.

I mean it.

Take a look at the guidance. It doesn’t have anything about the numbering in the document, only the *sections of the guidance* are numbered.

So go ahead, do something rational and number your document with “1″ at the body. Don’t number your title, synopsis, or TOC.

FDA has never, ever, ever, rejected a CSR because of the TOC numbering. Nor has any of the EMA agencies, Japan, or anybody else, to my knowledge.