Developer & Quality Control Review Checklist for SDS QRS Supplements - Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Item Library Version 1.0 Version Date 4/26/2020 (PRO-CTCAE V1.0 VERSION DATE 4/26/2020)

PROCESS: 

Two people - the developer and a quality-control reviewer - will need to review the checklist for each SDS QRS supplement developed as per QRS Subteam procedures (Flowchart - SDS QRS Supplement Development Process).  Once the developer and quality-control reviewer are in agreement that all items in the checklist are complete, the supplement will then be ready to enter CDISC internal review.

DEVELOPER: 

For each item below, confirm the item is correct in the supplement.  Check N/A boxes as applicable by placing the cursor over the check box and clicking the box.

QUALITY-CONTROL REVIEWER post-team review: 

For each item below:

1. Confirm the item is correct in the supplement and then check the box to the left of the item by placing the cursor over the check box and clicking the box. A check-mark will appear in the box and the item's font will turn light grey.  
2. Confirm that each item marked as not applicable does not apply to the supplement.  
3. If a condition is not met, add a note below the item explaining the concern.  
4. Contact the developer to alert them to the concern(s) and check either "All items meet checklist review" or "Revisions needed" in the header.
   
   

SUPPLEMENT

• General
  • All blue text is updated.
  • Updated text has been left blue for review; permanent template text has been left black.  
  • Pink instructional statements have been removed.
  • All comments have been resolved.
  • Hyperlinks are all functional.
  • Document conforms to current template.
  • Consistent spacing after periods. (1 space after a period)
  • Consistent spacing before and after math symbols. (space before and after in text. e.g., x = y; no space around hyphens in ranges. e.g., 2-3)
  • All parts of the page information header (document metadata) are correct and consistent, including title, version and correct date.
  • Document has been proofread for spelling, grammar, and accuracy by reviewers who were not authors.
  • Tables within document have consistent formatting and style (e.g., SDTM domain models all have consistent fonts, shading, and column widths).
  • Document has been considered for potential impact on other CDISC teams or underlying models (e.g., ADaM, 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.
• Section 2:
  • The annotated CRF has been attached to the page (unless restricted by copyright agreement).
  • The reference used in the --CAT CDISC definition is included as the reference in Section 2.
  • Any additional references apart from the --CAT reference have been vetted and no references to Amazon or other propaganda material have been included.
  • A copy of the reference has been attached to the wiki supplement page when available.
    • None available.
  • A copy of a User Manual has been attached to the wiki supplement page when available.
    
    • None Available
  • Public Domain 
    or
  • Copyrighted QRS (check the following:)
    • All additional copyright information has been included in Section 2 of the supplement (per information box).
  • Check with Dana/Steve that the public domain verification or copyright agreement is uploaded to the OneDrive.
• Section 3.1:
  • No assumptions have been made for information not collected on the QRS
  • All non-applicable assumptions from the template have been removed from the supplement.
  • The Non-Standard Variable (NSV) registry has been checked for supplemental qualifiers to ensure no duplication of either name or definition (i.e. the name of the proposed supplemental qualifier has not been used previously with a different definition and the definition has not previously been used for a different NSV.)
    • No supplemental qualifiers have been used in this supplement (There is no suppqs/supprs/suppft.xpt dataset example and no Section 5 Supplemental Qualifier Name Codes.).
• Section 3.2:
  • The example shows all items for at least one subject for at least one visit. All QRS Required and Expected variables have been included, and any Permissible variables that are needed to properly model all aspects of the QRS have been included. EXPECTED QRS fields that are not significant to the interpretation of the QRS do not need to be included in the example as long as a statement describing their absence is included.
  • The term 'subject' is used rather than 'patient' in the paragraph describing the example and any row captions prior to the table.
  • --ORRES values are all in the same case as the results shown on the QRS.
  • --CATs, synonyms, --TESTCDs, and --TESTs match up to Controlled Terminology.
  • --SCAT values are all uppercase.
    • No --SCAT values used in the supplement.
  • A SUPP-- example has been included if needed. A corresponding assumption has been included to describe the use of SUPP–.
    • No SUPPQS variables used in the supplement.
• Section 4:
  • Subcategories and the items they correspond to have been included.
    • No subcategories included in the supplement.
  • Additional standardization areas for the QRS Supplement and proposed standard values for all necessary QRS domain fields, such as Qualifier, Timing and Results needed in SDTM have been included (e.g. SPID, GRPID, REFID, EVAL, TPT, TPTNUM, EVLINT, ORRES, ORRESU, STRESC, STRESN, STRESU, etc.)
  • There is a page in QRS Maker for this QRS instrument and the mappings in Section 4 are the same as the output at the end of the QRS Maker page except the "- -" in the labels should have been replaced with either "QS", "FT", or "RS". If there are other differences, they should be noted here.
  • QRS Maker entries are correct.  If there are scores which have a test code, they should still be entered into QRS Maker. In addition, if there are values in the data that are not collected on the CRF, that should be noted in QRS Maker.

ANNOTATED CRF

• • Conforms to Study Data Tabulation Model Metadata Submission Guidelines (SDTM-MSG) annotated examples.
  • Per the Metadata example, Domain abbreviation = "Domain Name" (e.g., 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.
  • --CAT = QRS Short Name appears at the top of the page in Arial 12 point font, red color, bold, italicized, 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, bold, 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.
  • --ORRES, --STRESC and --STRESN 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.
  • EVAL is only annotated on the CRF when clearly identified on the CRF.
    • --EVAL is not listed on the CRF.
  • QNAM is annotated on the CRF for supplemental qualifier variables.
    • No QNAMs are used in the supplement.
  • Copyright or Public domain CDISC text box is on the CRF.