I have a question for statistical analysts in clinical development.
Is there any way to efficiently review the CDISC data (SDTM, ADaM) delivered from the CRO at the time of dry run?
What we mean by review here is not to check if the CDISC rules are being followed using Pinnacle, but to check if the data is being converted as per the spec instructions, if any abnormal values are being generated, etc. (Are there any other points to be noted?
(Are there any other areas I should be aware of?)
Currently, I am using
SAS: %data_specs
https://communities.sas.com/t5/SAS-Communities-Library/Library-Datasets-Summary-Macro-DATA-SPECS/ta-...
R: library(dataexplorer)
but is there a better way?
I look forward to hearing from you.
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