sdtm

AI SDTM mapping (R for ML, Python, TensorFlow for DL)

Development repo for pilot3 submission to FDA - ADaM

A free, open-source desktop application for transforming clinical trial data into FDA-compliant CDISC SDTM formats (XPT, Dataset-XML, Define-XML).

De-identifying CDISC SDTM data by Phuse rules using SAS

A dashboard to visualize what datasets were used to create each of the clinical trial datasets

Your Friendly Guide to Clinical Data Science with R in Open-Source

Unit conversion, verification with Unified Code for Units of Measure (Python)

Config-driven clinical trial ETL pipeline: Excel mapping → CDISC SDTM datasets + M5 regulatory submission package

MCP server for querying SDTM annotations from annotated CRF PDFs

DXT-packaged MCP server for the CDISC Library (discovery, Biomedical Concepts, SDTM Dataset Specializations)

R scripts to process clinical trial data using the CDISC SDTM and ADaM standards. It automates the transformation of raw clinical data into structured SDTM datasets (e.g., DM, AE, VS domains) and analysis-ready ADaM datasets (ADSL, ADAE, ADVS). The project includes statistical summaries, descriptive analytics, and viz

Code for the CDISC {admiral} hackathon, Feb 2023. The objective of this hackathon is to develop ADaM datasets in R using the ADaM in R Asset Library {admiral} and other Pharmaverse packages.

Automated generation of CDISC SDTM mapping specifications from REDCap field annotations, including CRF variable mapping, codelist management, REDCap choice alternatives, and similarity-based mapping between SDTM Submission Values and REDCap terms.

Transforms IDDO customised SDTM domains into analysis datasets

Turn CDISC SDTM PDFs into an AI-ready searchable knowledge base — 293 structured Markdown files, 63 domains, 37,939 terminology terms

A hands-on CDISC clinical programming course in SAS — raw CRF data to SDTM domains to ADaM analysis datasets to submission tables. 15 days, two synthetic studies, every program verified on SAS OnDemand.

Interactive learnr tutorials for clinical R programmers transitioning from SAS to the pharmaverse ecosystem (dplyr, admiral, sdtm.oak, metacore, xportr, teal and more). Built on real CDISC CDISCPILOT01 data.

caAdapter provides model mapping, data mapping and transformation services among data sources like HL7 and Regulatory Data Sets.

rCoreGage provides a high-speed framework for executing complex data checks across clinical domains. By automating the heavy lifting of DM/SDTM/ADaM/DM or any Data role issue tracking, it eliminates manual oversight and reduces data cleaning time. Engineered for large-scale trial data while maintaining strict adherence to data complaince

A Tauri 2 + Rust desktop tool for browsing CDISC (SDTM/ADaM) standards, exploring domain structures & variable metadata, editing validation rules with a custom DSL, and annotating CRF (Case Report Forms)