STUDYSAS BLOG

The Case Report Tabulation (CRT) is the collection of the annotated case report form (CRF), SAS® datasets, metadata, and source programs that comprise a portion of the NDA package submitted to the FDA. The FDA uses it when reviewing submissions. Review starts with the Define document which contains metadata describing the datasets, variables, and values. It is all tied together using internal and external hyperlinks, bookmarks, and destinations to make it easily navigable 1 . The CRT is essentially a collection of data and documentation for a study. It contains features such as bookmarks and links to allow reviewers to easily navigate the submission. For consistency, there are guidelines from FDA1 and CDISC defining the components though the guidelines are limited in scope. We need to create Define Document ( define.pdf or define.xml ) as a part of CRT. Each dataset is a single SAS transport file and, in general, includes a combination of raw and derived data. Each CRF domain (e.g., d...

Define.xml which generally describes what are we submitting to FDA .. like case Report Tabulations ( SAS datasets in XPT format, annotated CRF’s and the variables (metadata)) in a machine readable format….. In simple words it is .....Data and Metadata in Machine-Readable Format. It is considered as the standard process for submitting metadata to FDA and other regulatory bodies….