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The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values (attach QRS instrument here). (Note: Most copyright approvals allow annotated case report forms; if this is the case with the current instrument, keep item #3 and just remove this note. If however, the copyright agreement does not allow for annotated case report forms, remove item #3 along with this note.).

Info

Reviewers, 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.


Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology.

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