Decrypting SDTM Trial Design Datasets for Complex Study Designs
Source category: Data Standards & Governance
Author collections: Charumathy Sreeraman
THE COMMUNITY ARCHIVE
SDTM Papers and PresentationsPage 15
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 281–300
Define.xml Tools Supporting SEND/SDTM Data Process
Source category: Standards Implementation
Author collections: Kirsten Langendorf
Good versus better SDTM: Including Screen Failure Data in the Study SDTM?
Source category: Submission Standards
Author collections: Henry Winsor · Mario Widel
GUI Method of Mapping SDTM from Raw Data
Source category: Industry Starters
Author collections: Elisa Natale
Harmonizing SDTM at the Source: Designing Collection Instruments that Support Sponsor Standards
Source category: Data Standards & Governance
Author collections: Sue Huxtable · Charlotte Lomberg
Mapping of Gastrointestinal Tolerance Data to SDTM
Source category: Posters
Author collections: Lieke Gijsbers
Planning to Pool SDTM by Creating and Maintaining a Sponsor-Specific Controlled Terminology Database
Source category: Data Standards
Author collections: CORI KRAMER · Ragini Hari · Keith Shusterman
RELREC – SDTM Programmer’s Bermuda Triangle
Source category: Data Standards
Author collections: Charumathy Sreeraman
SDTM – Just a Walk in the (Theme) Park, Exploring SDTM in the Most Magical Place on Earth
Source category: Data Standards
Author collections: Christine McNichol
SDTM Cartography – Learn To Create SDTM Mapping Specifications
Source category: Industry Basics
Author collections: Donna Sattler · Mike Lozano
SDTM Domains by Query - is it Possible?
Source category: Trends & Technology
Author collections: Johannes Ulander
SDTM vs CDASH: Why You Need Them Both!
Source category: Data Standards & Governance
Author collections: Kit Howard · Shannon Labout
SDTM-ADaM Hybrid: Supermodel or Frankenstein?
Source category: Data Handling
Author collections: Ken Stoltzfus
Streamline SDTM Development and QC
Source category: Standards Implementation
Author collections: Stephen Gormley
The Benefits of Traceability Beyond Just From SDTM to ADaM in CDISC Standards
Source category: Data Standards
Author collections: Maggie Ci Jiang
The CDISC SDTM Exposure Domains (EX & EC) Demystified. How EC Helps You Produce A Better (more compliant) EX.
Source category: Data Standards
Author collections: Thomas Guinter
The Do’s/Don’ts, An SDTM Validation Perspective. The should/shouldn’t when explaining issues in the Study Data Reviewers Guide
Source category: Submission Standards
Author collections: Thomas Guinter
Visualising CDSIC SDTM for Monitoring and Review
Source category: Data Visualisation
Where Is the Link Broken – Another Look at SDTM Oncology Tumor Packages
Source category: Data Standards
A Macro to Automatically Flag Baseline in SDTM
Source category: Quick Tips
Author collections: Taylor Markway