Ready for Next Level SDTMs and ADaMs Compliance with End-to-End Processing?
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Sunil Gupta · Tomás Sabat Stofsel
THE COMMUNITY ARCHIVE
SDTM Papers and PresentationsPage 3
These papers examine the organization of clinical observations into SDTM domains, including mapping, controlled terminology and validation. Examples can help identify implementation questions; requirements may differ across standards versions and submission contexts.
345 papers · Showing 41–60
Ready for Next-Level SDTM and ADaM Compliance with End-to-End Processing?
Source category: Data Handling & Engineering
Author collections: Sunil Gupta
Reimagining SDTM Mapping with Agentic AI and Automation
Source category: Data Handling & Engineering
Author collections: Nathan Johnson
Revolutionising Clinical Data Transformation: Harnessing GenAI and Open Source for Automated SDTM Conversion
Source category: Artificial Intelligence, Machine Learning and Large Language Models
Author collections: Hao (Harry) Chen
Rule-Based Auto-SDTM Mapping Software in Python, Which Automatically Generates Executable SAS or R Programs
Source category: Emerging Trends & Innovation
Author collections: Bill Zhang
SAS to R: Opportunities and Challenges in SDTM and ADaM Transformation
Source category: Coding Tips & Tricks
Author collections: Jalendhar Ettedi
SDTM Automation: Implementation, Rollout and Lessons Learnt
Source category: Data Standards, Governance & Implementation
SDTM Navigator: An Agent-Based LLM Framework for Automated Specification and Programming
Source category: Software Demonstrations
Author collections: Jaya Simha Inampudi
SDTMIG v4.0: Are You Ready For It?
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Kristin Kelly
Submitting eCRT SDTM Data for ISS
Source category: Submissions & Agencies
SUPP to NSV: Transforming Data Representation for Improved Reviewer Utility
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Soumya Rajesh
Two Approaches to Phase-Specific TRTEMFL in ADAE: A Neoadjuvant–Adjuvant Case with Surgery Between Phases
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Why Standards Matter More Than Code in the Age of GenAI
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Bhavin Busa
{sdtm.oak} – SDTM Programming in R
Source category: Poster Presentations
Author collections: Rammprasad Ganapathy
{sdtm.oak} V0.1 on CRAN, sponsored by CDISC COSA, part of Pharmaverse, is an EDC and Data Standard agnostic solution for developing SDTM datasets in R.
Source category: R, Python, and Open Source Technologies
Author collections: Rammprasad Ganapathy
A Little Bit of This and That: Use cases, implementation, and documentation when using multiple CDISC standards, CTs, and regulatory guidances in an SDTM study
Source category: Submission Standards
Author collections: Charity Quick
Automating Preliminary CDISC SDTM Compliance Checks with a Customised SAS Macro
Source category: Poster Presentations
Author collections: Wei Qian
Automating SDTM Annotated CRF (aCRF) Creation
Source category: Scripts, Macros & Automation
Author collections: Christine Rossin
CDISCDataset.com: An AI-Powered Platform for Generating Synthetic CDISC-Compliant SDTM and ADaM Datasets, CRFs, Protocols, TFL Shells, and Specs
Source category: Application Development (AD)
Checking SDTM Datasets from Biostatistical Perspective
Source category: e-Posters
Author collections: Inka Leprince · Elizabeth Li