Nonclinical SDRG Template and Guide

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NOTE: The draft version mentioned here is the one from 2015 but is the correct one mentioned in the FDA's technical conformance guide. Please remove this note when draft is updated.

Current Drafts

Word Documents:

Archive

OLD version - used for Public PhUSE review Aug 2015:


Comments To Consider with FDA's review results

The following are from email messages dated Tue 8/25/2015 7:50 PM CDT, and Mon 8/10/2015 7:48 PM CDT:

  1. I think that having the study name in the page header is problematic. My original study title did not fit on one line of the header. For this sample I slightly renamed the study, but in real life that will not be possible. I’d suggest having only the study ID in the page header to avoid this problem.
  2. Study Title and Study ID on the first page is a different font than the rest of the document, and they are different from each other as well so the titlepage has 3 fonts.
  3. The template indents level to headers, but the text under the headers is left-margin aligned. This makes it difficult to see the subheaders in my opinion. I aligned all headings to the left margin in my sample. Either that or the text should align with the subheader indent (but that reduces the width of the page available for tables.
  4. In the ‘standards used’ table, it lists DEFINE.XML. The CDISC website list this (both 1.0 and 2.0) as DEFINE-XML
  5. Having a list of standard datasets in 4.1 and a list of nonstandard datasets in 6.3 is awkward. I’d suggest that the ‘description of the datasets’ requested in the TCG should be in one section (4 would be preferred, since that is Description of Study Datasets (does not need to be exclusively SEND datasets)
  6. We agreed a couple weeks ago that the checker software used was not relevent but it is still in the template text
  7. What is the purpose of the count on the rule table? It does not help the reader identify where in the dataset the problem occurs.
  8. The use guide does not say whether all sections should remain in the document with Not Applicable or some notation when a section is described with “if necessary”. I omitted to keep the document tidy.
  9. There’s a typo in the first paragraph of the completion guide: "Nonclincal" should be replaced with "Nonclinical"
  10. Should the supplemental qualifiers be individually described, for example like this?
Dataset Name Variable Name (QNAM) Variable label (QLABEL) Description
SUPPMA MARESMOD Result Modifiers Modifiers that were part of MAORRES for which SEND variables have not yet been developed
SUPPMI MIRESMOD Result Modifiers Modifiers that were part of MIORRES for which SEND variables have not yet been developed