Friction to Flow: LLM-Based Automation of Clinical Data Workflows
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Pankaj Attri · Matt Becker
THE COMMUNITY ARCHIVE
SDTM Papers and PresentationsPage 2
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 21–40
From Black Box to Glass Box: A Context-Aware Approach to SDTM Mapping Automation with Interactive Visual Validation
Source category: Data Visualisations
Author collections: Rostislav Markov · Jacques Lanoue
From Data Flood to Insight: Efficient SDTM Validation for High-Frequency Sources
Source category: Submission Standards for Global Health Authorities
Author collections: Seiko Yamazaki
From Manual to Automated”: An SAS® and R-Based Toolkit for Scalable SDTM Generation
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Hardik Sheth
From Specification to SDTM at Speed: Deploying the SDTM Engine in Production
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Jacques Lanoue · Ulf Nielsen
Handling multiple screenings and multiple enrollments in SDTM: CDISC and FDA Guidance
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Laura Williams
Harmonising gsm and the pharmaverse: Orchestrating SDTM, ADaM, TFLs and ARS in a Unified R Workflow
Source category: Open Source Technologies
Hero-in-the-Loop: A Super Squad Approach to SDTM Creation & Validation
Source category: ePosters
Author collections: Julie Ann Hood
Human Beings Still Needed: Manual ADaM Checks that AI Can’t Do
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Sandra Minjoe · Mario Widel
Improving Risk-Based QA in Outsourced Studies Using Cross-Domain ADaM Derivation Comparisons
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Incorporating Digital Health Technology (DHT) Data in SDTM – Challenges and Examples
Source category: Poster Presentations
Author collections: Sandra VanPelt Nguyen
ISO 8601 and SAS®—and R! A Practical Approach
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Derek Morgan · Marckenley Mercie
Mapping Minimal Residual Disease (MRD) Biomarker Data in Haematologic Malignancies: Clinical Significance and Data Standards in SDTM and ADaM
Source category: Data Standards, Governance & Implementation
Author collections: Jyothi Nelakurthi
Navigating the Statistical Programming Strategies for Cytokine Release Syndrome (CRS) and ICANS in Oncology Clinical Trials.
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Murali Kanakenahalli · Vamsi Kandimalla
Not Another Other: Bridging Data Collection with SDTM Mapping Without Open Text Fields
Source category: Data Standards, Governance & Implementation
Optimising Flexibility and Consistency in Statistical Programming for Platform Trials: Practical Approaches to Data Cut, SDTM, ADaM and TFL Setup
Source category: Poster Presentations
Author collections: Zhen (Laura) Li
Optimising Vendor Data Mapping: From Raw to SDTM and Ready for Analysis
Source category: Poster Presentations
Picking Up the Pieces: Implementation of (the forgotten) ADaM Naming Fragments
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Richann Watson · Karl Miller
Practical Lessons in AI-Assisted Metadata Conversion: From Database Specs to EDC and SDTM — Successes, Pitfalls, and Practical Implementation
Source category: AI in Pharma, Biotech and Clinical Data Science
R You Ready for SDTM? Let {sdtm.oak} Do the Heavy Lifting
Source category: Poster Presentations