Green = Recent FDA Changes

Pink = Instructional information for developers

Blue = Text can change from supplement to supplement based on the instrument

Black = Standard template language

1. Copy QS Template page and move to the Initial development (not ready for review) page. Please DO NOT OVERWRITE the template pages.
   1. If the supplement is based on a measurement system, such as PRO-CTCAE V1.0, FACIT, PROMIS, etc., replace the word instrument with measurement system throughout the supplement.
2. The "–" in this template represents the domain implemented for the instrument. This is replaced with the 2-character domain abbreviation of FT, QS, or RS that is used for the instrument.
3. Change the title of the page as follows:
   1. Remove 'Copy of QRS Supplement Template - '.
   2. Replace 'Name of QRS Instrument' with the full name of the QRS instrument the supplement is being created for.
   3. Change 'QRS Short_Name' to the short name (--CAT) for the current instrument.
4. Update the information in the Page Properties block below as indicated in the block below.
   1. The supplement version number in the header section will be 'v1' if there has never been a supplement for the instrument before. Otherwise, increment as appropriate.
   2. If the CRF was copyright approved, keep 'Approved'; otherwise change 'Approved' to 'Public Domain'.
5. Replace 'Title' and 'QRS Short_Name' throughout the document with the title and short name of the instrument that the supplement is being created for.
6. Replace royal blue text with information pertaining to the instrument the supplement is being created for. Delete royal blue text which does not apply to the new instrument.
7. Unless otherwise noted, text in black applies to all QRS Supplements and should not be deleted, but should be examined carefully and revised as appropriate based on the specific instrument supplement as needed. Any changes need to be in blue font to stand out for review.
8. Change QS to RS or FT and 'Questionnaires' to 'Disease Response and Clin Classification' or 'Functional Tests' as appropriate.
9. Remove all information blocks, except for the one immediately below this called 'Information for Reviewers'.
10. Keep changes in blue for ease throughout internal and public review. Once the supplement has gone thru public review and all comments are resolved, change all text color to black except for hyperlinks.
11. Arabic numerals (0, 1, 2, 3, etc.) are used to express numbers in most circumstances. Exceptions are the following: 
    • Numbers that begin a sentence, title, subtitle, or heading 

    • Common fractions 

    • Accepted usage such as idiomatic expressions and numbers used as pronouns 

    • Other uses of “one” in running text (e.g., when meaning "a")
    • Ordinals first through ninth
    • Numbers spelled out in quotes or published titles.

Text in black is part of the template used to create this document and is not revised under CDISC internal or public review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

Include the following statements as standalone paragraphs for copyrighted instruments:

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges [insert the name of the copyright holder, in blue text] (e.g., Dr. A. J. Rush, at the UT Southwestern Medical Center) for the approval to include the QRS Short_Name in the CDISC data standards.

Only include the actual references and all material used in developing the supplement on the reference section below. This should be a reference paper or a website reference in place of a paper.

This is an example only.  Use the reference from the CDISC definition of the --CAT.

• do not include the parentheses.
• do not include copyright information from the definition about copyright holder and version since that's already included above.
• do add a period to the end. 

If there are multiple references, please use the following format:

References for the QRS Short_Name:

• CDISC Controlled Terminology reference.
• additional reference.

Notes on the use of quotation marks:

• Use for text values of a Likert scale: e.g., ...with response options ranging from “never” to “daily."
• Actual numbers of the scale (e.g., 0-3) do not appear in quotation marks while the definitions of these anchors (e.g., 5 = “I always fall asleep”) do.
• Enclose values for variables within quotation marks (e.g., QSTESTCD = "IPA0102")

Update the data in the table below to the current instrument. Include row descriptions as needed to highlight idiosyncrasies or items otherwise of note in this particular instrument. If only 1 or 2 row descriptions are needed, then the information should be included as a paragraph instead.

For the not done visit that is now being included in all QRS supplements, when no reason is collected, information should be included, either in the paragraph before, or as a row description as follows:

When the reason is collected for a not done visit, information or a row description should be added as follows:

We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument, so we ask that you please review the example below.

The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

Text that would remain unchanged has been left in black:

The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

Include mappings for all sets of result values. For ease of use of this template, the complete set of response values for the example in Section 3.2 is not included.

If the instrument has been entered into QRS Maker (all instruments should be), then the complete set of response values can be copied from QRS Maker and pasted into this supplement.

Some example mappings are below.

For QRS instruments with subcategories:

When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results.

QSSCAT alignment with QSTESTCD

As stated in Section 3.1 assumptions, items on the QRS Short_Name are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

• If this is a public domain instrument that has an individual item with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.

  • The controlled response terminology for the tests below is named --TESTCDOR for the variable RSORRES and --TESTCDSTR for the variables RSSTRESN and RSSTTRESC.

• If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.
  • The controlled response terminology for the tests below is named --TESTCDTXXXOR for the variable RSORRES and --TESTCDTXXXTSTR for the variables RSSTRESN and RSSTTRESC.

If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:

"All QSTESTCDs"

Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.

If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses. This approach used the CDISC QRS CT instrument's SYNONYM as part of the codelist name.

The controlled response terminology for the tests below is named SYNONYMSET1OR for the variable RSORRES and SYNONYMSET1STR for the variables RSSTRESN and RSSTTRESC.

If there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:

QSTESTCD = "test code 1" QSTEST = "test name 1"

QSTESTCD = "test code 4" QSTEST = "test name 4"

QSTESTCD = "test code 5" QSTEST = "test name 5"

QSTESTCD = "test code 6" QSTEST = "test name 6"

QSTESTCD = "test code 7" QSTEST = "test name 7"

QSTESTCD = "test code 8" QSTEST = "test name 8"

QSTESTCD = "test code 15" QSTEST = "test name 15"

QSTESTCD = "test code 22" QSTEST = "test name 22"

QSTESTCD = "test code 27" QSTEST = "test name 27"

QSTESTCD = "test code 29" QSTEST = "test name 29"

Omit the QSSTRESN column when it is not applicable to the dataset.

QSTESTCD = "test code" QSTEST = "test name"

If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.

• • The controlled response terminology for the tests below is named --TESTCDTXXXOR for the variable RSORRES and --TESTCDTXXXTSTR for the variables RSSTRESN and RSSTTRESC.

For responses that are for 8 or more consecutive items, an override label should be used in QRS Maker to show the items that are included as follows:

QSTESTCD = "first test code in sequence" QSTEST = "first test name in sequence" through

QSTESTCD = "last test code in sequence" QSTEST = "last test name in sequence"

The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black.

Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed.

Remove Section 5 if it does not apply to the new instrument.