openstudyval-package: Open validator for FDA study-data submissions
In openstudyval: Open Validator for FDA Study-Data Submissions
openstudyval-package R Documentation
Open validator for FDA study-data submissions
Description
Validates a study folder against publicly described FDA technical-rejection
criteria, SAS XPORT constraints, and an extensible SDTM, SEND, and ADaM
structural catalog. Independent of Pinnacle 21 and not an FDA certification.
Author(s)
Shekhar Eranna Chalwadi
See Also
validate_submission, rules_catalog
openstudyval documentation built on Oct. 21, 2026, 5:14 p.m.
R Package Documentation
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| openstudyval-package | R Documentation |
Open validator for FDA study-data submissions
Description
Validates a study folder against publicly described FDA technical-rejection criteria, SAS XPORT constraints, and an extensible SDTM, SEND, and ADaM structural catalog. Independent of Pinnacle 21 and not an FDA certification.
Author(s)
Shekhar Eranna Chalwadi
See Also
validate_submission, rules_catalog
R Package Documentation
Browse R Packages
We want your feedback!
Note that we can't provide technical support on individual packages. You should contact the package authors for that.
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