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SDTM Papers and PresentationsPage 7

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 121–140

PHUSE · 2024Paper SM13PHUSE US Connect 2024

Streamlining the Integration of SDTM Datasets from Multiple Studies: A Macro Approach

Vijay Anuroop Reddy Allam; Santosh Reddy Lekkala

Source category: Scripts, Macros & Automation

Author collections: Santosh Reddy Lekkala

WUSS · 2024Paper 179WUSS 2024

Training Domain Specific AI for Clinical Data: Developing an AI Agent to Transform EDC data to CDISC SDTM and then to ADaM Standards

Sy J Truong

Source category: Lectures

PHUSE · 2024Paper SI07PHUSE US Connect 2024

Transforming RWD for Regulatory Submissions: How to Use SDTM for RWD

Sam Hume; Tasha Nagamine

Source category: Standards Implementation

Author collections: Sam Hume · Tasha Nagamine

PharmaSUG · 2024Paper SD-243PharmaSUG 2024

Unravelling the SDTM Automation Process through the Utilization of SDTM Transformation Template

Lakshmi Mantha; Inbasakaran Ramesh

Source category: Solution Development

Author collections: Lakshmi Mantha

PharmaSUG · 2023Paper DS-186PharmaSUG 2023

‘TUFF’ LOVE: SDTM Pain Points EXPLAINED!

Kristin Kelly; Michael Beers

Source category: Data Standards

Author collections: Kristin Kelly · Michael Beers

PHUSE · 2023Paper DH07PHUSE EU Connect 2023

A Robust Framework to Provide and Validate Real-Time SDTM Data

Bremer Louw

Source category: Data Handling & Data Engineering

Author collections: Bremer Louw

PharmaSUG · 2023Paper SS-304PharmaSUG 2023

As Simple as Falling Off a Log?: An Unusual Case Study of Mapping Data into the SDTM DA (Drug Accountability) Domain

Susan Mutter

Source category: Submission Standards

PHUSE · 2023Paper SI01PHUSE US Connect 2023

Automating SDTM and ADaM Creation in Clinical Trials

Lyubov Sushchenko; Rie Ichihashi

Source category: Standards Implementation

Author collections: Lyubov Sushchenko · Rie Ichihashi

PharmaSUG · 2023Paper MM-205PharmaSUG 2023

Automating SDTM: A metadata-driven journey.

Keith Hibbetts

Source category: Metadata Management

Author collections: Keith Hibbetts

PharmaSUG · 2023Paper DS-193PharmaSUG 2023

Can We Do It Better? Real-Time Validation Of Sdtm Mapping Is Superior To Double Programming

Daniel Rolo; Bremer Louw

Source category: Data Standards

Author collections: Bremer Louw

PharmaSUG · 2023Paper DS-114PharmaSUG 2023

CDISC SDTM IG v3.4: Subject Visits

Ajay Gupta

Source category: Data Standards

Author collections: Ajay Gupta

PHUSE · 2023Paper PP28PHUSE US Connect 2023

DIY: Building a Raw Metadata Library with Integrated SDTM Annotations

Sanjiv Ramalingam; Shriram Sivaraman

Source category: Poster Presentation

Author collections: Sanjiv Ramalingam

PHUSE · 2023Paper SD04PHUSE US Connect 2023

EDC Raw Data to SDTM Curation, Mapping and Automation with XBiom Tool

Sunil Gupta; Rahul Madhavan

Source category: Software Demonstrations

Author collections: Sunil Gupta

PHUSE · 2023Paper PP28PHUSE EU Connect 2023

Enhancing the Quality of Data Harmonisation – a Customisable Tool for Validation of Bespoke SDTM Implementation at the Infectious Diseases Data Observatory (IDDO)

Sadie Kelly; Dick Hung

Source category: Poster Presentations

Author collections: Sadie Kelly

PHUSE · 2023Paper SS08PHUSE US Connect 2023

Exploring the Possibility of Automating SDTM Domain Subject Visits (SV)

Limna Salim

Source category: Scripts & Snippets

Author collections: Limna Salim

SESUG · 2023Paper 226SESUG 2023

For Clinical Trials: A Faster and Smoother Approach to Create your SDTM and ADAM Define Specifications for Define.xml with SAS®

Star Nze

Source category: Industry Applications

PHUSE · 2023Paper SI07PHUSE EU Connect 2023

Gear Up SDTM with Digital Health Devices

Vicky Poulsen

Source category: Standards Implementation

Author collections: Vicky Poulsen

PHUSE · 2023Paper PP23PHUSE EU Connect 2023

Guidance on SDTM for Liquid Oncology Endpoints

Swaroop Koduri; Tyagrajan Swaminathan

Source category: Poster Presentations

Author collections: Tyagrajan Swaminathan

PharmaSUG · 2023Paper SS-282PharmaSUG 2023

Handling of Vaccine SDTM Data for FDA CBER/OVRR Submission Compliance

Pragathi Mudundi; Zhaoyu Xie

Source category: Submission Standards

Author collections: Pragathi Mudundi · Zhaoyu Xie

PharmaSUG · 2023Paper DS-129PharmaSUG 2023

Have Meaningful Relationships: An Example of Implementing SDTM Special Purpose Data Set RELREC with a Many-to-Many Relationship

Kaleigh Ragan; Richann Watson

Source category: Data Standards

Author collections: Richann Watson