About the review of CDISC data

sskt — Fri, 02 Sep 2022 17:00:15 GMT

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-p/544757
R: library(dataexplorer)
but is there a better way?

I look forward to hearing from you.

Re: About the review of CDISC data

Ksharp — Sat, 03 Sep 2022 10:17:45 GMT

You could use this free software "SAS Clinical Standard Toolkit" to validate the SDTM or ADaM dataset is right or not .
https://github.com/sassoftware/clinical-standards-toolkit

Or if you have money ,Buy JUMP software from SAS .
https://www.jmp.com/
As fas as I know about half of FDA people to use JMP to check CDISC dataset .

topic Re: About the review of CDISC data in SAS Programming

About the review of CDISC data

Re: About the review of CDISC data