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Clinical Study Data Reviewer's Guide (cSDRG) Package

Clinical Study Data Reviewer's Guide (cSDRG) Package

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Last updated: May 16, 2022 by Former user (Deleted)

OverviewVersion/Publication DateLink 
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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