A Flexible Metadata-Driven and Modular Approach to SDTM Automation
Source category: Pharma & Healthcare
THE COMMUNITY ARCHIVE
SDTM Papers and Presentations
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 1–20
A specification-driven approach to improve the reliability of AI-generated SDTM transformation programs
Source category: AI in Pharma, Biotech and Clinical Data Science
Author collections: Rostislav Markov
AI-Augmented SDTM Review: A Practical Framework Enhanced by a Structured Prompt Library
Source category: AI in Pharma, Biotech and Clinical Data Science
Author collections: Vihar Patel
Analysis Concepts role within the CDISC 360i vision
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Alyssa Wittle · Brian Harris
Approaches Integrating SAS LSAF and Pinnacle 21 Enterprise for SDTM/ADaM Dataset Validation
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: James Zhao · Joshua Lin
AUTOCODE: Metadata-Driven Automation for Faster, Traceable SDTM and ADaM Programming
Source category: Scripts, Macros & Automation
Author collections: Matthew Finnemeyer
Automated Quality Checks for SDTM and ADaM Datasets Using R Shiny
Source category: Tools, Tech & Innovation
Author collections: Shih-Che (Danny) Hsu · Wei Qian
Automating SDTM Compliance: A Web-Based SDTM Quality Control Tool Enhancing Clinical Trial Data Integrity
Source category: Poster Presentations
Author collections: Indraneel Narisetty
Automating SDTM Subject Visits (SV) Derivation A Configuration-Driven, Meta-Programming Approach in SAS
Source category: Pharma & Healthcare
Batch Execution of CDISC SDTM/ADaM Programs with R
Source category: Scripts, Macros & Automation
Author collections: Denny Sebastian · Mohin Mohanan
Beyond WHODrug: Insight into Concomitant Medication Data Analysis
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Song Liu · Rambabu Sura
Building High-Quality SDTM from Real-World Data: Lessons and Solutions
Source category: Data Standards, Governance & Implementation
Author collections: Peishan(Jenny) Han · Lixiao Chen
Case Study: Leveraging CDISC CORE for Proactive SDTM Compliance and Submission Readiness
Source category: Data Standards, Governance & Implementation
Author collections: Shivani Gupta
Closing the Loop: Validating AI-Generated SDTM Mappings using CDISC CORE and Synthetic Data
Source category: Submission Standards for Global Health Authorities
CTCAE v6.0: The Good, the Bad, and the Ugly
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Elizabeth Dennis · Grace Fawcett
Democratising SDTM Transformations: AI-Assisted Function Development with Business-Driven Governance
Source category: Artificial Intelligence, Machine Learning and Large Language Models
Author collections: Ulf Nielsen · Rostislav Markov
DOSEON: Fuzzy Matching DOSE Date Intervals ON Analysis Dates Across SAS (PROC SQL, SAS Macro, DATA Step, and PROC FCMP)
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Inka Leprince · Troy Hughes
Elevating Transparency in Data Standardisation: Applying XAI in SDTM, ADaM, and TFL Generation
Source category: Machine Learning, AI & Large Language Models, Data Handling & Data Engineering
Enhancing CDISC Standards Implementation (SDTM and ADaM) with PROC FCMP, PROC IML and Macro Loop Integration in Oncology Clinical Trials.
Source category: ePosters
Author collections: Ajay Gupta · Misikir Tesfaye
Enhancing Clinical Data Standardisation Through Intelligent Mapping of eCRF Forms and Items to SDTM
Source category: Machine Learning, AI & Large Language Models, Data Handling & Data Engineering
Author collections: Kedar Deshpande