Clinical Study Data Reviewer's Guide (cSDRG) Package

The cSDRG provides regulatory agency reviewers an orientation to the submitted tabulation data in a consistent way and usable format. This Package includes information on the Legacy Data Conversion Plan and Report (LDCP) appendix. The cSDRG Package includes the template, completion guidelines, examples, and example traceability diagrams.

Version 1.3, 2-Nov-2018

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