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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.
Getting started
Browse package contents
Package details |
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| Author | Shekhar Eranna Chalwadi [aut, cre] |
| Maintainer | Shekhar Eranna Chalwadi <skrchalwadicg@gmail.com> |
| License | MIT + file LICENSE |
| Version | 0.1.1 |
| URL | https://github.com/shekharchalwadigrepo-hub/openstudyval |
| Package repository | View on CRAN |
| Installation |
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