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sdtmval  

Validate SDTM Domains
View on CRAN: Click here


Download and install sdtmval package within the R console
Install from CRAN:
install.packages("sdtmval")

Install from Github:
library("remotes")
install_github("cran/sdtmval")

Install by package version:
library("remotes")
install_version("sdtmval", "0.4.1")



Attach the package and use:
library("sdtmval")
Maintained by
Stephen Knapp
[Scholar Profile | Author Map]
First Published: 2023-10-23
Latest Update: 2023-10-23
Description:
Provides a set of tools to assist statistical programmers in validating Study Data Tabulation Model (SDTM) domain data sets. Statistical programmers are required to validate that a SDTM data set domain has been programmed correctly, per the SDTM Implementation Guide (SDTMIG) by 'CDISC' (), study specification, and study protocol using a process called double programming. Double programming involves two different programmers independently converting the raw electronic data cut (EDC) data into a SDTM domain data table and comparing their results to ensure accurate standardization of the data. One of these attempts is termed 'production' and the other 'validation'. Generally, production runs are the official programs for submittals and these are written in 'SAS'. Validation runs can be programmed in another language, in this case 'R'.
How to cite:
Stephen Knapp (2023). sdtmval: Validate SDTM Domains. R package version 0.4.1, https://cran.r-project.org/web/packages/sdtmval. Accessed 29 Mar. 2025.
Previous versions and publish date:
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Complete documentation for sdtmval
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