openstudyval - Open Validator for FDA Study-Data Submissions
Validates clinical and nonclinical study-data packages
against publicly described FDA technical-rejection criteria,
SAS XPORT constraints from the Study Data Technical Conformance
Guide, and an extensible catalog of SDTM, SEND, and ADaM
structural conformance checks. Reads a study folder of CSV,
RDS, or (when the suggested package haven is installed) SAS
v5/v8 transport files, optionally checks define.xml, and writes
a submission-style HTML and CSV validation report. This package
is an independent open-source implementation. It is not
affiliated with, endorsed by, or a copy of Pinnacle 21,
Certara, or the FDA.
