Define-XML is the metadata that describes the content and formatting of submission datasets and the case report tabulation data. It’s needed to help reviewers understand the data they are reviewing.
What is an annotated CRF? An annotated CRF documents the location in a database of the data collected for each question on a form. In other words, it’s a mapping between each item on a form to its ...
This repository contains all code to create Define-XML 2.1 from CDISC SDTM Dataset Specializations for RECIST 1.1 Oncology domains (RS, TR, TU). For more information about CDISC SDTM Dataset ...
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