Bridging the Divide: Harmonising HL7 FHIR, OMOP and CDISC Standards for Regulatory-Grade Real-World Evidence
Source category: Data Standards, Governance & Implementation & Submissions & Agencies
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CDISC Papers and PresentationsPage 2
Browse practical discussions of clinical data standards, from collected observations to analysis datasets and supporting metadata. Use the more focused ADaM, SDTM and Define-XML collections to follow a particular stage of the workflow.
856 papers · Showing 21–40
Building ADaM Datasets from Scratch using R: A SAS programmer’s Perspective
Source category: Emerging Technologies (R, Python, GitHub etc.)
Author collections: Patel Mukesh
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: Integrating ADPPK CDISC Standards into Pharmacometric Programming and Analysis Workflows
Source category: ePosters
Author collections: Renuka Hegde · Erin Dombrowsky · Neelima Thanneer
Case Study: Leveraging CDISC CORE for Proactive SDTM Compliance and Submission Readiness
Source category: Data Standards, Governance & Implementation
Author collections: Shivani Gupta
CDISC 360i – Lessons Learned and Road Ahead
Source category: India CDISC Day
Author collections: Peter Van Reusel
CDISC 360i Demo: Automating from Study Design to Submission
Source category: Data Standards, Governance & Implementation
Author collections: Darren Moreland
CDISC 360i In Action – Demonstrating the Shift to Fully Digital Standards
Source category: India CDISC Day
Author collections: Julie Smiley · Darren Moreland
CDISC 360i: From Vision to Implementation – Lessons Learned and the Road Ahead
Source category: Data Standards, Governance & Implementation
Author collections: Peter Van Reusel
CDISC Analysis Concepts Initial Perspectives from the CDISC Working Group
Source category: India CDISC Day
Author collections: Stuart Malcolm
CDISC ARS Template Code: Gearing Up with Automation in TFL Programming
Source category: Scripts, Macros & Automation
Author collections: Malan Bosman
CDISC Biomedical Concepts for Breast Cancer: A CDISC 360i Perspective
Source category: Data Standards, Governance & Implementation
Author collections: Bess LeRoy · Brian Harris
Challenges and Solutions for Generating Synthetic CDISC Data
Source category: Emerging Trends & Innovation
Author collections: Sundaresh Sankaran · Cat Briggs
Closing the Loop: Validating AI-Generated SDTM Mappings using CDISC CORE and Synthetic Data
Source category: Submission Standards for Global Health Authorities
Consolidation of CDISC ADaM
Source category: ePosters
Author collections: Trevor Mankus · Tatiana Sotingco · Alyssa Wittle
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
Data Without Borders: CDISC Data Hub for Multi-Language Clinical Analytics & AI
Source category: AI in Pharma, Biotech and Clinical Data Science
Author collections: Mayank Singh
DefinePageChecker: A Python Tool for Verifying Page Number Hyperlinks in Define.xml
Source category: ePosters
Author collections: Xianhua Zeng
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
Do One Task, Get Another Done for Free: Use DEFX Tags in Comments to Fill Out Your define.xml
Source category: Advanced Programming
Author collections: Brendan Bartley