Guidance Beyond the SDTM Implementation Guide
Source category: Data Standards & Governance
Author collections: Kristin Kelly · Michael Beers
THE COMMUNITY ARCHIVE
SDTM Papers and PresentationsPage 6
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 101–120
Guidance Beyond the SDTM Implementation Guide
Source category: Data Standards & Governance
Author collections: Kristin Kelly · Michael Beers
Guideline for Creating Unique Subject Identifier in Pooled studies for SDTM
Source category: Data Standards
Handling of Humoral and Cellular Immunogenicity Data in SDTM
Source category: Data Standards
Author collections: Wei Duan
Harmonisation and Interoperability Between OMOP CDM and CDISC SDTM
Source category: Real-world Evidence
Author collections: Dhruba Sikdar
How to Monitor SDTM Data Health
Source category: Data Handling & Engineering
Ingenious Raw Data Tracking in SDTM Programs: A New Perspective
Source category: Data Handling & Engineering
Author collections: Bhanojinaidu Duppada · Sumanth Goud Bheemagani
Journey of Reactogenicity Data from EDC to SDTM to Analysis Datasets
Source category: Therapeutic Areas Specific Topics
Author collections: Charumathy Sreeraman · Jisha George
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
Our Road to Adopting CORE: An Implementation Journey in SDTM Dataset Validation
Source category: Standards Implementation
Author collections: Marisa Wyckmans
Perl Regular Expressions in SDTM and ADaM Programming: Live Study Examples
Source category: Coding Tips & Tricks
Programming with SAS PROC DS2: Experience with SDTM/ADaM
Source category: Advanced Programming
Revolutionising SDTM Transformation in Pharma: Introducing {oak} – An Open-Source R Package Sponsored by CDISC COSA
Source category: Open Source Technologies
Author collections: Rammprasad Ganapathy
SDTM Specifications and Datasets Review Tips
Source category: Data Standards
Author collections: Wanchian Chen
SDTM/ADaM Automation – Challenges and Issues from a Programmer’s Perspective While Exploring an Automation Attempt to Address Them
Source category: Scripts, Macros & Automation
Streamlined EDC data to SDTM Mapping with Medidata RAVE ALS
Source category: Solution Development
Author collections: Yunsheng Wang · Chao Wang · Tina Wu