QS Supplement QC Checklist
Document Template V1.0 May 20, 2013
Completed by (QS
Implementer:
Date Completed:
QS Name and Version of
Deliverable:
Please indicate by marking with an “X” each of the below criteria to verify all of the
following before submission. To do so, double-click on the box, and select the “Checked”
option.
QS Supplement Example GREEN font update areas to address:
Title page conforms to QS Supplement naming convention (.ex Brief Psychiatric Rating Scale-Anchored
(BPRS-A). Coordinate “Prepared by” name if other than the QS Sub-Team.
Revision History table is updated with date of the current document, version and summary of changes.
1 Introduction Updates:
 Paragraph 1 updated with QS name with short description
 Paragraph 2 updated permission status and CRF
2 Copyright Status Updates:
 Paragraph 1 updated based on public domain or copyright permission granted.
 Paragraph 2 updated if an annotated CRF is not included for the questionnaire.
 Paragraph 4 updated based on public domain or copyright permission granted.
 Paragraph 5 updated with the same questionnaire reference use in the QS Controlled Terminology
spreadsheet.
3.1 Assumptions for Questionnaire Domain Model Updates:
 Paragraph 1 is updated with the questionnaire name.
 Paragraph 2 always includes a description of the questionnaire.
 Include bullets as needed to describe any specific items related to the questionnaire.
 Include a bullet to describe any derivations approved to be included in the questionnaire
 Similar bullets for the following items should be included for all questionnaires.
o Time period of evaluation using either QSEVLINT or QNAM=EVLINTTX (only provide the
evaluation interval if it is clearly indicated on the CRF documentation, do not create a value based
on assumptions)
o Questionnaire Evaluator
o Terminology
3.2 Example for the questionnaire is updated with the questionnaire name
 Provide at least one data example. The example should show all questions for at least one subject for at
least one visit. Include all QS Required and Expected variables, and any Permissible variables that are
needed to properly model all aspects of the questionnaire. EXPECTED QS fields that are not significant to
the interpretation of the questionnaire do not need to be included in the example as long as a statement
describing their absence is included.
 QSORRES values should be in the same case as the printed results on the questionnaire itself.
 Paragraph 1 is updated with questionnaire short name that is used in the controlled terminology field for
QSCAT and a description of the example.
 Include row descriptions for all rows in the example table.
 Include a SUPPQS example if needed. An assumption is needed to describe the use of SUPPQS.
4 SDTM Mapping Strategy
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QS Supplement QC Checklist
Document Template V1.0 May 20, 2013

Identify additional standardization areas for the QS Supplement and propose standard values for all
necessary QS domain fields, such as Qualifier, Timing and Results needed in SDTM (.ex SPID, GRPID,
REFID, EVAL, TPT, TPTNUM, EVLINT, ORRES, ORRESU, STRESC, STRESN, STRESU, etc.
 Use the published QS Controlled Terminology for QSTESTCD and QSTEST to represent each question.
Questions that have the exact same set of responses may be grouped together.
5 Supplemental Qualifier Name Codes
 Include as necessary
General Document QC items:
Annotated CRF Document conforms to the Study Data Tabulation Model Metadata Submission Guidelines
(SDTM-MSG):
 Per the Metadata example, QS=Questionnaires appears at the top of the page in Arial 18 point font, black
color, bolded, and italicized. It is enclosed in a black 1 point thickness text box with a light blue fill color.
 Variable annotations are in Arial 10 or 12 point font, red color, bolded, and italicized. They are enclosed in
a black 1 point thickness text box with a light blue fill color. Be consistent within a page and use 12 point
unless space is an issue and then use 10 pt.
 QSORRES, QSSTRESC and QSSTRESN are annotated if these results are clearly identified on the CRF.
Repetition of these annotations may be eliminated if it clearly identifies these variables are repeated on
subsequent questions.
 Do not add assigned values as annotations on the CRF. QSEVAL is an example and is only annotated on
the CRF when clearly identified on the CRF. Assigned values are covered in the QS Supplement document.
Document conforms to current template; styles have been verified for consistent fonts, headings, and consistent
spacing after periods.
Headers and footers are correct and consistent on all pages, including title, version and correct date.
Document has been spell-checked.
Document has been proofread for grammar and accuracy by reviewers who were not authors.
Tables within document have consistent formatting and style (e.g., SDTM domain models all have a consistent
fonts, shading, and column widths).
References to examples, tables, and figures are correct and consistent.
Document has been considered for potential impact on other CDISC teams or underlying models (e.g., SDTM,
BRIDG). They have been alerted and invited to comment.
If structural modifications or extensions (e.g., new or changed variables, domains, classes, etc.) to an existing
model (e.g., SDTM, BRIDG) are proposed, the rationale for these is described in the document package.
Documents in posting package have been converted to PDF and checked for correct PDF pagination.
Review package includes QC Checklist, QS Supplement (WORD & PDF), Annotated CRF (PDF),
Questionnaire Reference Document and Signed CDISC Copyright Letter
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