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CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards. The PAR provided CRF has updated the item names represented on the CRF that were described in the original reference.
The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Functional Tests (FT) domain model, which can be found at the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.
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The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) case report form(s) annotated with the CDISC SDTMIG submission values. The PAR provided CRF has updated the item names represented on the CRF that were described in the original reference.
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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. |
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