pharmaversesdtm 1.4.0 Release

We are pleased to announce the release of {pharmaversesdtm} 1.4.0 🎉
This release expands the breadth of SDTM test data available in the package, with a particular focus on neurology and oncology, alongside several targeted enhancements and fixes.

✨ What’s New in 1.4.0

🧠 New neurological SDTM test datasets

Version 1.4.0 introduces a set of neurology-focused SDTM test datasets, extending the package coverage of therapeutic areas:

• dm_neuro – demographic data for neurological studies
  
• nv_neuro – neurological findings
  
• suppnv_neuro – supplemental qualifiers for neurological findings
  
• ag_neuro – associated groups for neurological domains
  
• lb_neuro – neurological laboratory test data

These datasets are intended to support development, testing, and examples for neurology-specific workflows.

📊 New and updated variables

Several existing datasets have been enhanced:

• VISITDY has been added to the pc domain to support consistent visit day derivations.
• BRTHDTC has been added to both dm and dm_metabolic, improving demographic completeness.
• The qs_ophtha dataset now uses an updated QSTESTCD aligned with CDISC terminology and has been simplified for easier use in examples.

🧬 Oncology data improvements

This release also includes important updates for oncology use cases:

• Corrections to rs_onco_pcwg3, addressing misclassified progression indicators and response records.
• A new oncology biomarker dataset, lb_onco_pcwg3, providing PSA measurements aligned with PCWG criteria.

🧠 Neurological dataset enhancements

Neurological laboratory data includes biomarkers Alpha Synuclein Seed Amplification Assay (CSF), Lumipulse G pTau217, Lumipulse G β-Amyloid 1-42, and the ratio of pTau217 and β-Amyloid 1-42.

📚 Documentation and developer updates

To help you explore datasets by therapeutic area, the reference pages have been reorganized to group datasets under meaningful categories such as metabolic, neurological, and oncology. This makes navigation easier for researchers and developers alike.

📦 Installation

You can install pharmaversesdtm 1.4.0 from CRAN:

install.packages("pharmaversesdtm")

@online{patil2026,
  author = {Patil, Lina},
  title = {Pharmaversesdtm 1.4.0 {Release}},
  date = {2026-01-23},
  url = {https://pharmaverse.github.io/blog/posts/2026-01-23_pharmaversesdtm14/pharmaversesdtm_1.4.0_release.html},
  langid = {en}
}