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changes.mady.by.user Steve Kopko

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changes.mady.by.user Unknown User (ksmith)

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Info
titlecolor coding

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

Info
titleInstructions on how to use this template
  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.

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