If the supplement is based on a measurement system, such as PRO-CTCAE V1.0, FACIT, PROMIS, etc., replace the word instrument with mesurement system throughout the supplement.
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.
Change the title of the page as follows:
Remove 'Copy of QRS Supplement Template - '.
Replace 'Name of QRS Instrument' with the full name of the QRS instrument the supplement is being created for.
Change 'QRS Short_Name' to the short name (--CAT) for the current instrument.
Update the information in the Page Properties block below as indicated in the block below.
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.
If the CRF was copyright approved, keep 'Approved'; otherwise change 'Approved' to 'Public Domain'.
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.
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.
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.
Change QS to RS or FT and 'Questionnaires' to 'Disease Response and Clin Classification' or 'Functional Tests' as appropriate.Also when discussing the instrument as a general rule refer to it as instrument.
Remove all information blocks, except for the one immediately below this called 'Information for Reviewers'.
Keep changes inblue 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.
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.
...
Page properties
Title
Name of QRS instrument (QRS Short_Name)
CDISC Reference
Questionnaire (or 'Clinical Classification' or 'Functional Test', as appropriate) Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name
QRS Short_Name
QRS Permission Status
Approved(or 'Public Domain, Exempt from Copyright', as appropriate)
Team
Standards team QRS instrument is being developed for (e.g., Major Depressive Disorder Standards Team), if applicable, and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version
1.0 (or higher as appropriate when doing a supplement revision)
Status
DRAFT(or "REVISION DRAFT" or "FINAL", as appropriate). Status will not be considered "Final" until the supplement is ready to be sent for publication.
Date
yyyy-mm-dd(date current version released, regardless of status - this date should always match the date in the Revision History section below and should be updated every time this supplement is edited.)
Notes
This supplement is intended available to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument. (Use only for instruments this applies to.)
Known Issues
Only include this row to describe any known issues related to the supplement. If there are no issues, this row can be deleted.