THE COMMUNITY ARCHIVE

CDISC Papers and PresentationsPage 37

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 721–740

PHUSE · 2017Paper DV05PHUSE EU Connect 2017

Visualising CDSIC SDTM for Monitoring and Review

Philip Bartle

Source category: Data Visualisation

PharmaSUG · 2017Paper DS07PharmaSUG 2017

Where Is the Link Broken – Another Look at SDTM Oncology Tumor Packages

Hong Wang; Ke Xiao

Source category: Data Standards

Author collections: Hong Wang · Ke Xiao

PharmaSUG · 2016Paper DS06PharmaSUG 2016

“It is a standard, so it is simple, right?”: Misconceptions and Organizational Challenges of Implementing CDISC at a CRO

Susan H.M. Boquist; Adam J. Sicard

Source category: Data Standards

PharmaSUG · 2016Paper QT19PharmaSUG 2016

A Macro to Automatically Flag Baseline in SDTM

Taylor Markway

Source category: Quick Tips

Author collections: Taylor Markway

PharmaSUG · 2016Paper SS05PharmaSUG 2016

A Practical Approach to Re-sizing Character Variable Lengths for FDA Submission Datasets (both SDTM and ADaM)

Xiangchen (Bob) Cui; Min Chen

Source category: Submission Standards

Author collections: Xiangchen (Bob) Cui · Min Chen

PharmaSUG · 2016Paper SS08PharmaSUG 2016

A SAS® Macro Tool to Automate Generation of Define.xml V2.0 from SDTM Specification for FDA Submission

Min Chen; Xiangchen (Bob) Cui

Source category: Submission Standards

Author collections: Min Chen · Xiangchen (Bob) Cui

PHUSE · 2016Paper CD06PHUSE EU Connect 2016

Analysis Datasets for Baseline Characteristics and Exposure Time for Multi-stage Clinical Trials

Kimberly Umans; Katherine Riester

Source category: CDISC & Industry Standards

PHUSE · 2016Paper CD11PHUSE EU Connect 2016

Analysis Results Metadata...Are We There Yet?

Carla Santillán

Source category: CDISC & Industry Standards

Author collections: Carla Santillan

PHUSE · 2016Paper CD04PHUSE EU Connect 2016

Assessing CDISC Therapeutic Area User Guides in a Machine Readable Format

Johannes Ulander; Niels Both

Source category: CDISC & Industry Standards

Author collections: Johannes Ulander · Niels Both

PharmaSUG · 2016Paper PO22PharmaSUG 2016

Automatic Consistency Checking of Controlled Terminology among SDTM Datasets, Define.xml, and NCI/CDISC Controlled Terminology for FDA Submission

Min Chen; Xiangchen (Bob) Cui

Source category: Posters

Author collections: Min Chen · Xiangchen (Bob) Cui

PHUSE · 2016Paper PP11PHUSE EU Connect 2016

Automating ADaM

Helen Hart; Christof Binder

Source category: Poster Presentations

Author collections: Christof Binder

PharmaSUG · 2016Paper PO24PharmaSUG 2016

Building Efficiency and Quality in SDTM Development Cycle

Kishore Pothuri; Bhavin Busa

Source category: Posters

Author collections: Kishore Pothuri · Bhavin Busa

PHUSE · 2016Paper CD02PHUSE EU Connect 2016

CDASH V2.0: What is it Good For?Éanna Kiely, inVentiv Health

Éanna Kiely

Source category: CDISC & Industry Standards

The publisher-listed Paper file is currently unavailable.

Author collections: Éanna Kiely

PharmaSUG · 2016Paper PO12PharmaSUG 2016

CDISC Standards End-to-End: Transitional Hurdles

Alyssa Wittle; Christine McNichol; Antonio Cardozo

Source category: Posters

Author collections: Alyssa Wittle · Christine McNichol · Antonio Cardozo

PharmaSUG · 2016Paper DS12PharmaSUG 2016

Conformance, Compliance, and Validation: An ADaM Team Lead’s Perspective

John Troxell

Source category: Data Standards

Author collections: John Troxell

PharmaSUG · 2016Paper AD18PharmaSUG 2016

Consider Define.xml Generation during Development of CDISC Dataset Mapping Specifications

Vara Prasad Sakampally; Bhavin Busa

Source category: Applications Development

Author collections: Bhavin Busa

PHUSE · 2016Paper CD09PHUSE EU Connect 2016

Constructing a Clinical Data Warehouse for Nutrition Studies

Paul Vervuren

Source category: CDISC & Industry Standards

Author collections: Paul Vervuren

SESUG · 2016Paper CC-167SESUG 2016

Converting Non-Imputed Partial Dates (for SDTM Data Sets) Using PROC FCMP

Noory Y. Kim

Source category: Coders Corner

File inside source ZIP: Coders Corner/CC-167_Final_PDF.pdf

PharmaSUG · 2016Paper SS01PharmaSUG 2016

Creating Define-XML version 2 including Analysis Results Metadata with the SAS® Clinical Standards Toolkit

Lex Jansen

Source category: Submission Standards

Author collections: Lex Jansen

PharmaSUG · 2016Paper PO07PharmaSUG 2016

Creating Time to Event ADaM Dataset for a Complex Efficacy Endpoint in Multiple Sclerosis Therapeutic Area

Ittai Rambach

Source category: Posters