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CDISC Papers and PresentationsPage 19

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 361–380

PHUSE · 2022Paper PP20PHUSE EU Connect 2022

Using Janssen’s ADaM Submission RPA Bot to Successfully Prepare for Delivery of an ADaM Submission Package

Andrew Noller

Source category: Poster Presentations

PHUSE · 2022Paper OS01PHUSE US Connect 2022

Using odmlib to Create ODM and Define-XML Tools in Python

Samuel Hume

Source category: Open Source Technologies

Author collections: Samuel Hume

PharmaSUG · 2021Paper QT-111PharmaSUG 2021

A Unique Way to Identify the Errors in SDTM Annotations Using SAS

Xingxing Wu; Bala Dhungana

Source category: Quick Tips

Author collections: Xingxing Wu

PHUSE · 2021Paper SD01PHUSE US Connect 2021

ADaM Generator Tool

Gustav Bernard

Source category: Software Demonstration

Author collections: Gustav Bernard

PharmaSUG · 2021Paper MD-035PharmaSUG 2021

ADaM Implementation Guide for Medical Devices

Julia Yang; Silvia Faini; Karin LaPann

Source category: Medical Devices

Author collections: Julia Yang · Silvia Faini · Karin LaPann

PharmaSUG · 2021Paper DS-102PharmaSUG 2021

ADaM-like Dataset: how to do big things in a short time

Oksana Mykhailova; Andrii Klekov

Source category: Data Standards

Author collections: Oksana Mykhailova

PHUSE · 2021Paper SI03PHUSE EU Connect 2021

Advanced Excel Specification for Automatic SDTM Generation

Aleksandra Gorbunova; Ilya Mishchenko

Source category: Standards Implementation

SAS Communities · 2021Paper 1112-2021SAS Global Forum 2021

Analyzing Data Missing Due to COVID-19: From Raw Data to ADaM and Beyond

Yuliia Bahatska, Roche

Source category: SAS Global Forum proceedings

PHUSE · 2021Paper SI08PHUSE US Connect 2021

Automation of CDISC ADaM Using Statistical Data and Metadata eXchange (SDMX)

Stuart Malcolm

Source category: Standards Implementation

Author collections: Stuart Malcolm

PharmaSUG · 2021Paper DS-142PharmaSUG 2021

Biomedical Concepts – An Emerging CDISC Data Standard: A Stepwise Approach for Building a Library of Data Definitions

Kirsten Langendorf; Johannes Ulander

Source category: Data Standards

Author collections: Kirsten Langendorf · Johannes Ulander

PHUSE · 2021Paper SI06PHUSE EU Connect 2021

Bringing to Light – Analysis Results Metadata v1.0 for Define-XML v2

Hrishikesh K S; Limna Salim

Source category: Standards Implementation

Author collections: Hrishikesh K S · Limna Salim

PharmaSUG · 2021Paper DS-014PharmaSUG 2021

CDISC ADaM Phases, Periods, and Subperiods: A Case Study

Jennifer Fulton

Source category: Data Standards

Author collections: Jennifer Fulton

PHUSE · 2021Paper DS08PHUSE EU Connect 2021

CDISC Analysis Results Standard Team: Enhancing Analysis Results and Traceability

Bess LeRoy; Jeffrey Abolafia

Source category: Data Standards & Governance

Author collections: Bess LeRoy · Jeffrey Abolafia

PHUSE · 2021Paper SI05PHUSE US Connect 2021

Challenges and Solutions in SDTM Implementation and Programming of the Ophthalmic Examinations (OE) Domain

Shivam Kumar; Vinita Dora

Source category: Standards Implementation

Author collections: Shivam Kumar · Vinita Dora

PharmaSUG · 2021Paper FDA-002PharmaSUG 2021

Collaborative Review of CDISC QRS Instruments

Steve Wilson; Steve Kopko; Dana Booth

Source category: FDA Tuesday

Author collections: Steve Wilson · Steve Kopko · Dana Booth

PharmaSUG · 2021Paper DS-037PharmaSUG 2021

Creating Hyperlinks in SDTM Specifications

Carey Smoak

Source category: Data Standards

Author collections: Carey Smoak

PharmaSUG · 2021Paper EP-143PharmaSUG 2021

Customizing define.xml files

Steffen Müller

Source category: ePosters

PharmaSUG · 2021Paper SS-016PharmaSUG 2021

Design ADaM Specification Template that Simplifies ADaM Programming and Creation of Define XML in CDISC Era

Xiang Wang; Daniel Huang

Source category: Submission Standards

Author collections: Xiang Wang

PharmaSUG · 2021Paper SS-137PharmaSUG 2021

Effective Approach for ADaM Submission to FDA and PMDA

Ranvir Singh

Source category: Submission Standards

PharmaSUG · 2021Paper AD-168PharmaSUG 2021

Extracting Data Standards Metadata and Controlled Terminology from the CDISC Library using SAS with PROC LUA

Lex Jansen

Source category: Applications Development

Author collections: Lex Jansen