THE COMMUNITY ARCHIVE

CDISC Papers and PresentationsPage 11

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 201–220

PHUSE · 2024Paper DH04PHUSE US Connect 2024

Data Handling through CDISC Standards in Master Protocols: A Focus on Rescreened and Re-Enrolled Subjects

Swathi Kotla; Madhusudhan Reddy Papasani

Source category: Data Handling & Engineering

Author collections: Swathi Kotla · Madhusudhan Reddy Papasani

PHUSE · 2024Paper DS11PHUSE EU Connect 2024

Data Integration on CDISC ADaM Level: Multi-Purpose Structure of ADSL and BDS Datasets

Renate Scheiner-Sparna

Source category: Data Standards & Governance

Author collections: Renate Scheiner-Sparna

PharmaSUG · 2024Paper SD-255PharmaSUG 2024

Define-XML Conversion: A General Approach on Content Extraction Using Python

Danfeng Fu; Dickson Wanjau; Ben Gao

Source category: Solution Development

Author collections: Danfeng Fu · Dickson Wanjau

PharmaSUG · 2024Paper SS-368PharmaSUG 2024

Design Considerations for ADaM Protocol Deviations Dataset in Vaccine Studies

Rashmi Gundaralahalli Ramesh; Jeffrey Lavenberg

Source category: Submission Standards

PHUSE · 2024Paper PP20PHUSE US Connect 2024

Dynamic CDISC Analysis Results Data with the R Package {cards}

Daniel Sjoberg

Source category: Poster Presentations

Author collections: Daniel Sjoberg

PHUSE · 2024Paper SI06PHUSE US Connect 2024

Electronic Clinical Outcome Assessment (eCOA) in SDTM: Challenges and a Solution

Shivam Kumar

Source category: Standards Implementation

Author collections: Shivam Kumar

PharmaSUG · 2024Paper PO-292PharmaSUG 2024

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

Julie Ann Hood; Jennifer Manzi

Source category: e-Posters

Author collections: Julie Ann Hood · Jennifer Manzi

PHUSE · 2024Paper DH02PHUSE US Connect 2024

Eliminating SDTM Double Programming by Using a Validation Tool and Dummy Data

Glenn Borgmans; Tine Seeuws

Source category: Data Handling & Engineering

Author collections: Glenn Borgmans · Tine Seeuws

PharmaSUG · 2024Paper PO-123PharmaSUG 2024

Enhancing Define-XML Generation: Based on SAS Programming and Pinnacle 21 Community

Kevin Sun

Source category: e-Posters

PHUSE · 2024Paper DS13PHUSE EU Connect 2024

Estimands: How to Make ADaM Implementation Your Friend

Dennis Kusian; Jaclyn Amberg

Source category: Data Standards & Governance

PHUSE · 2024Paper DS05PHUSE EU Connect 2024

FDA Business Rules and CDISC Open Rules: The Road to Adoption

Nick De Donder

Source category: Data Standards & Governance

Author collections: Nick De Donder

PHUSE · 2024Paper RE03PHUSE US Connect 2024

Future Clinical Data Submission Standards: CDISC, FHIR, OMOP, or Hybrid Model

Jeffrey Abolafia

Source category: Real-world Evidence

Author collections: Jeffrey Abolafia

PharmaSUG · 2024Paper DS-406PharmaSUG 2024

Game changer! The new CDISC ADaM domain ADNCA for PK/PD data analysis

Santosh Ranjan

Source category: Data Standards

PHUSE · 2024Paper SI09PHUSE US Connect 2024

Getting More Efficiency from Your Instruments Using CDISC

Frank Menius

Source category: Standards Implementation

Author collections: Frank Menius

PHUSE · 2024Paper DS04PHUSE US Connect 2024

Getting Started with the New CDISC Analysis Results Standard

Bess LeRoy

Source category: Data Standards & Governance

Author collections: Bess LeRoy

PharmaSUG · 2024Paper DS-274PharmaSUG 2024

Guidance Beyond the SDTM Implementation Guide

Kristin Kelly; Michael Beers

Source category: Data Standards

Author collections: Kristin Kelly · Michael Beers

PHUSE · 2024Paper DS03PHUSE EU Connect 2024

Guidance Beyond the SDTM Implementation Guide

Kristin Kelly; Michael Beers

Source category: Data Standards & Governance

Author collections: Kristin Kelly · Michael Beers

PHUSE · 2024Paper DS08PHUSE US Connect 2024

Guidance Beyond the SDTM Implementation Guide

Kristin Kelly; Michael Beers

Source category: Data Standards & Governance

Author collections: Kristin Kelly · Michael Beers

PharmaSUG · 2024Paper DS-305PharmaSUG 2024

Guideline for Creating Unique Subject Identifier in Pooled studies for SDTM

Vibhavari Honrao

Source category: Data Standards

PharmaSUG · 2024Paper DS-367PharmaSUG 2024

Handling of Humoral and Cellular Immunogenicity Data in SDTM

Wei Duan

Source category: Data Standards

Author collections: Wei Duan