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SDTM Papers and PresentationsPage 4

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 61–80

PharmaSUG · 2025Paper MM-227PharmaSUG 2025

Does SDTM Validation Really Require Double Programming?

Sunil Gupta; Tomás Sabat Stofsel

Source category: Metadata Management

Author collections: Sunil Gupta · Tomás Sabat Stofsel

PHUSE · 2025Paper SA08PHUSE EU Connect 2025

Efficient Conversion of SDTM/ADaM Specifications from Excel to Define-XML v2.1 Using Pinnacle 21 Community

Hiromi Okada; Seiko Yamazaki

Source category: Submissions & Agencies (SA)

Author collections: Seiko Yamazaki

PHUSE · 2025Paper OS14PHUSE US Connect 2025

Effortless SDTM Upversioning: Leveraging Open-Source R for Efficient Data Standardisation

Ramya Gangadi

Source category: OS

Author collections: Ramya Gangadi

PHUSE · 2025Paper PP20PHUSE US Connect 2025

Elevate Your Game: Levelling Up SDTM Validation with the Magic of Data Managers

Julie Ann Hood; Jennifer Manzi

Source category: Poster Presentations

Author collections: Julie Ann Hood · Jennifer Manzi

PharmaSUG · 2025Paper SI-224PharmaSUG 2025

Elevating Clinical Research: Strategic Implementation of CDASH and SDTM Standards

Hayden Patel

Source category: Strategic Implementation & Innovation

SESUG · 2025Paper 58SESUG 2025

Ensure complete raw data to SDTM mapping: a SAS macro approach for quality control

Cally Davidson, Eric Howard

Source category: Data Collection, Management, and Manipulation (DCMM)

File inside source ZIP: 58-Cally-Davidson-supporting-document.pdf

PharmaSUG · 2025Paper SS-344PharmaSUG 2025

Ensuring Data Integrity: Techniques for Validating SDTM Datasets in Clinical Research

Amy Welsh

Source category: Submission Standards

PHUSE · 2025Paper DS11PHUSE US Connect 2025

Evolution of Genomic Data Mapping from PF to GF in SDTM v3.4: Concepts, Challenges and Controlled Terminology with Genetic Variation Examples

Rama Kudaravalli

Source category: Data Standards & Governance

Author collections: Rama Kudaravalli

PHUSE · 2025Paper TT06PHUSE EU Connect 2025

From SDTM to a Graph-Based, Multi-Purpose Interface for Data

Eva Kelty; Catharina Dahlbo

Source category: Trends & Technology (TT)

Author collections: Eva Kelty · Catharina Dahlbo

PHUSE · 2025Paper DS13PHUSE US Connect 2025

Innovative Storage of SDTM Mappings as JSON: Boosting Efficiency and Data Consistency

Rohan Parmar; Edgar Manukyan

Source category: Data Standards & Governance

Author collections: Rohan Parmar

PHUSE · 2025Paper SM15PHUSE US Connect 2025

Kraken: A Shiny Application for Visualising SDTM Data in Early-Phase Clinical Trials

Rutu Patel

Source category: Scripts, Macros & Automation

PharmaSUG · 2025Paper AP-157PharmaSUG 2025

Macro to Compare ADaM Spec Derivations Against Available SDTM Data

Ingrid Shu; Kexin Guan; Jeff Xia

Source category: Advanced Programming

Author collections: Ingrid Shu · Kexin Guan · Jeff Xia

PHUSE · 2025Paper RE01PHUSE US Connect 2025

Mapping OMAP Data to SDTM – Use Case for RWD in CAR-T Registry Studies

Kai Deng; Joe Xi

Source category: Real-world Evidence

Author collections: Joe Xi

PharmaSUG · 2025Paper SI-159PharmaSUG 2025

Navigating the transition of legacy processes for SDTM creation

Jyothi Ketavarapu

Source category: Strategic Implementation & Innovation

PHUSE · 2025Paper DS18PHUSE US Connect 2025

Optimising SDTM and ADaM: Remediation Techniques for Data Accuracy

Kishore Pothuri

Source category: Data Standards & Governance

Author collections: Kishore Pothuri

MWSUG · 2025Paper AE-082MWSUG 2025

Prompt, Program, Submit: Generative AI for Faster SDTM, ADaM, and TLFs

Matt Becker; Pankaj Attri

Source category: AI and Emerging Technology

Author collections: Matt Becker · Pankaj Attri

WUSS · 2025Paper PH-154WUSS 2025

Prompt, Program, Submit: Generative AI for Faster SDTM, ADaM, and TLFs

Matt Becker

Source category: Pharma and Healthcare

Author collections: Matt Becker

PHUSE · 2025Paper SD07PHUSE US Connect 2025

SDTM Automation by Using Metadata to Drive R Functions for Data Transformation

Krishna Gopal; Jaya Simha Inampudi

Source category: Software Demonstrations

Author collections: Krishna Gopal · Jaya Simha Inampudi

PHUSE · 2025Paper ML20PHUSE US Connect 2025

SDTM Specification Automation Using an ML Approach to Provide Mappings

Benzi Mathew; Jaya Simha Inampudi

Source category: Machine Learning, AI and Large Language Models

Author collections: Jaya Simha Inampudi

PharmaSUG · 2025Paper SI-180PharmaSUG 2025

SDTM Transformation through Artificial Intelligence (AI) and Human in the Loop (HITL): Lessons Learnt from Abbvie Case Study

Aman Thukral; Sanjay Bhardwaj

Source category: Strategic Implementation & Innovation

Author collections: Aman Thukral