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CDISC Papers and Presentations

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 1–20

WUSS · 2026Paper PH-144WUSS 2026

A Flexible Metadata-Driven and Modular Approach to SDTM Automation

Ruili Shi; Jiaying Zhang; Charles Chen

Source category: Pharma & Healthcare

PharmaSUG · 2026Paper AI-332PharmaSUG 2026

A Human-in-the-Loop AI-Assisted Framework for ADaM Standardization

Chunqiu Xia; Feiyang Du

Source category: AI in Pharma, Biotech and Clinical Data Science

Author collections: Chunqiu Xia

PharmaSUG · 2026Paper AI-420PharmaSUG 2026

A specification-driven approach to improve the reliability of AI-generated SDTM transformation programs

Rostislav Markov

Source category: AI in Pharma, Biotech and Clinical Data Science

Author collections: Rostislav Markov

PharmaSUG · 2026Paper AI-141PharmaSUG 2026

Accelerating CDISC SEND Conversion with AI: From Raw Preclinical Data to Regulatory-Ready Datasets

Nattawit Pewngam; Chotika Chatgasem; Titipat Achakulvisut

Source category: AI in Pharma, Biotech and Clinical Data Science

PharmaSUG · 2026Paper PN-245PharmaSUG 2026

ADaM Pet Peeves Part 2: More Things Programmers Do That Make Us Crazy

Sandra Minjoe; Nancy Brucken; Alyssa Wittle; Nate Freimark; Richann Watson; Paul Slagle; Tatiana Sotingco

Source category: Panel Discussions

Author collections: Sandra Minjoe · Nancy Brucken · Alyssa Wittle · Richann Watson · Paul Slagle · Tatiana Sotingco

PharmaSUG · 2026Paper AI-259PharmaSUG 2026

AI-Augmented SDTM Review: A Practical Framework Enhanced by a Structured Prompt Library

Vihar Patel

Source category: AI in Pharma, Biotech and Clinical Data Science

Author collections: Vihar Patel

PharmaSUG · 2026Paper AI-278PharmaSUG 2026

AI-Driven Intelligent Platforms for ADaM Specification and Code: Empowering Clinical Data Analysis

Tingting Zeng; Jia He; Yaohui Zhu; Shuang Gao; Jinling Li; Nana Yang

Source category: AI in Pharma, Biotech and Clinical Data Science

PharmaSUG · 2026Paper AI-431PharmaSUG 2026

AI-Powered Multiple-Agent Pipeline for Automating ADaM Dataset Generation

Lucas Liu; Bo Ci

Source category: AI in Pharma, Biotech and Clinical Data Science

Author collections: Bo Ci

PHUSE · 2026Paper ML09PHUSE US Connect 2026

AI-Powered Multiple-Agent Pipeline for Automating ADaM Dataset Generation

Bo Ci

Source category: Artificial Intelligence, Machine Learning and Large Language Models

Author collections: Bo Ci

PHUSE · 2026Paper DH02PHUSE US Connect 2026

Analysis Concepts Definition: Initial Perspectives from the CDISC Working Group

Stuart Malcolm

Source category: Data Handling & Engineering

Author collections: Stuart Malcolm

PharmaSUG · 2026Paper DS-350PharmaSUG 2026

Analysis Concepts role within the CDISC 360i vision

Alyssa Wittle; Brian Harris

Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)

Author collections: Alyssa Wittle · Brian Harris

PharmaSUG · 2026Paper DS-286PharmaSUG 2026

Approaches Integrating SAS LSAF and Pinnacle 21 Enterprise for SDTM/ADaM Dataset Validation

James Zhao; Joshua Lin

Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)

Author collections: James Zhao · Joshua Lin

PHUSE · 2026Paper DS04PHUSE US Connect 2026

Around the Data DOSE-y Doe: Using DOSExx Variables within ADaM Datasets

Inka Leprince; Richann Jean Watson

Source category: Data Standards, Governance & Implementation

Author collections: Inka Leprince · Richann Jean Watson

PHUSE · 2026Paper PP04PHUSE APAC Connect 2026

Auto-Mapping of CDISC Standards Using Agentic AI

Nithyanandan Thangavelu; Rohit Bailur

Source category: Poster Presentations

PHUSE · 2026Paper SM06PHUSE US Connect 2026

AUTOCODE: Metadata-Driven Automation for Faster, Traceable SDTM and ADaM Programming

Matthew Finnemeyer

Source category: Scripts, Macros & Automation

Author collections: Matthew Finnemeyer

PharmaSUG · 2026Paper TT-118PharmaSUG 2026

Automated Quality Checks for SDTM and ADaM Datasets Using R Shiny

Shih-Che (Danny) Hsu; Wei Qian

Source category: Tools, Tech & Innovation

Author collections: Shih-Che (Danny) Hsu · Wei Qian

PHUSE · 2026Paper PP03PHUSE US Connect 2026

Automating SDTM Compliance: A Web-Based SDTM Quality Control Tool Enhancing Clinical Trial Data Integrity

Indraneel Narisetty; Gopal Reddy Palvatla

Source category: Poster Presentations

Author collections: Indraneel Narisetty

WUSS · 2026Paper PH-151WUSS 2026

Automating SDTM Subject Visits (SV) Derivation A Configuration-Driven, Meta-Programming Approach in SAS

Huiqing Chen

Source category: Pharma & Healthcare

PHUSE · 2026Paper SM09PHUSE APAC Connect 2026

Batch Execution of CDISC SDTM/ADaM Programs with R

Denny Sebastian; Mohin Mohanan

Source category: Scripts, Macros & Automation

Author collections: Denny Sebastian · Mohin Mohanan

PharmaSUG · 2026Paper DS-368PharmaSUG 2026

Beyond WHODrug: Insight into Concomitant Medication Data Analysis

Song Liu; Martin Nielsen; Rambabu Sura

Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)

Author collections: Song Liu · Rambabu Sura