According to CDISC: SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process.

SDTM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).

sdtmchecks

Contains data check functions to identify SDTM issues that are generalizable, actionable, and meaningful for analysis

datacutr

Applying a datacut to SDTM

Upcoming packages for consideration

The following are being worked up towards open sourcing to be considered for later inclusion into the pharmaverse - we felt important to share here in case others are working in a similar space and would be interested to collaborate with the respective developers.

roak

SDTM mapping algorithms via R functions OPEN SOURCE RELEASE EXPECTED ~MID-2023 Contact Ram Ganapathy (ganapar1@gene.com)

In addition, a collaboration of 7 companies is being formed to tackle “Open Source test data generation” for SDTM mapping via an R package. it would be focused on test data from EDC systems that is needed to test SDTM mapping.