Agenda for 3-5-2021 Meeting #9
joseph-rickert
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Agenda:
9:00: Doug Kelkhoff - R Validation Hub infrastructure
9:05: Nan Xiao the R package pkglite which packs/unpacks multiple R packages into txt file is going to be used in an upcoming FDA pilot eCTD submission
9:30: Open discussion
We will continue the discussion initiated by Paul Schuette last time about modifying the software section of the study data technical conformance guide: https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources
An MS word copy of the section has been placed in the documents section for comments and suggestions.
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