Harmonisation and Interoperability Between OMOP CDM and CDISC SDTM
Source category: Real-world Evidence
Author collections: Dhruba Sikdar
THE COMMUNITY ARCHIVE
CDISC Papers and PresentationsPage 12
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 221–240
How to generate a submission ready ADaM for complex data
Source category: Submission Standards
Author collections: Tina Wu
How to Monitor SDTM Data Health
Source category: Data Handling & Engineering
ICH M11 Clinical Electronic Structure Harmonised Protocol (CeSHarP) and CDISC: Making the Electronic Protocol a Reality
Source category: Data Standards & Governance
Author collections: Peter Van Reusel
ICH M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP) and CDISC: Making the Electronic Protocol a Reality
Source category: Data Standards & Governance
Author collections: Peter Van Reusel
ID-SPECTACKLE: Making ADaM Specifications ‘Fun’
Source category: Scripts, Macros & Automation
Author collections: Lionel Debecq
Implementing CDISC CORE in a Cloud-Native, Regulated Environment to Support Rare Diseases Submissions
Source category: Standards Implementation
Author collections: Stijn Rogiers · Emmy Pahmer
Ingenious Raw Data Tracking in SDTM Programs: A New Perspective
Source category: Data Handling & Engineering
Author collections: Bhanojinaidu Duppada · Sumanth Goud Bheemagani
Insights of Using {admiralonco} at BMS: Facilitating Oncology Efficacy ADaM Datasets
Source category: Scripts, Macros & Automation
Author collections: Yirong Cao · Yi Yan
Interactive Reporting Using FDA Standard Safety Shells and the CDISC Analysis Results Standard
Source category: Data Visualisation
Author collections: Megan Harries
Introduction to the ADNCA ADaM
Source category: Poster Presentations
Is a Participation-Level ADaM Dataset a Solution for Submitting Integration Data to FDA?
Source category: Submission Standards
Author collections: Sandra Minjoe
Journey of Reactogenicity Data from EDC to SDTM to Analysis Datasets
Source category: Therapeutic Areas Specific Topics
Author collections: Charumathy Sreeraman · Jisha George
Lessons Learned From the ADaM Data Development Using ADMIRAL
Source category: Poster Presentations
Making SDTM/ADaM CRT Packages Submission Ready
Source category: Submissions & Agencies
Author collections: Phillip Spowart
Managing a Single Set of SDTM and ADaM Specifications across All Your Phase 1 Trials
Source category: Metadata Management
Author collections: Avani Kaja
Mapping Real-World Data (RWD) to SDTM Samples for External Control Arm or Registry Studies
Source category: Real-world Evidence
Author collections: Joe Xi
Mastering Pinnacle 21 for Oncology SDTM
Source category: Data Standards & Governance
Author collections: Daryna Khololovych
OAK Productivity Experiment – How We Made SDTM Programming 5x Faster
Source category: Standards Implementation
Author collections: Amy Franklin · Magdalena Krochmal
Oncology ADaM Datasets Creation Using R Programming: A Comprehensive Approach
Source category: Statistics and Analytics