THE COMMUNITY ARCHIVE

SDTM Papers and PresentationsPage 12

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 221–240

PHUSE · 2019Paper RW03PHUSE EU Connect 2019

RW03 Early Experiences Using SDTM to Organise Clinical Data Collected Using a Physical Activity Tracker

Martin Gram; Gianluca Mortari

Source category: Real World Evidence

Author collections: Martin Gram · Gianluca Mortari

PHUSE · 2019Paper SD01PHUSE US Connect 2019

SD01 DR3 – A Tool to Create Define-XML (SDTM/ADaM with ARM)

Eric Weising

Source category: Software Demonstrations

Author collections: Eric Weising

PHUSE · 2019Paper DH02PHUSE EU Connect 2019

SDTM Validation Tool

Anamaria Calai

Source category: Data Handling

PHUSE · 2019Paper SI01PHUSE US Connect 2019

SI01 End-to-End SDTM Automation: A Metadata-centric Approach

Roman Radelicki; Swapna Pothula

Source category: Standards Implementation

Author collections: Roman Radelicki · Swapna Pothula

PHUSE · 2019Paper SI04PHUSE EU Connect 2019

SI04 Mapping Raw Data to SDTM Define Using the SAS Clinical Standards Toolkit

Andrew Bullivant

Source category: Standards Implementation

PHUSE · 2019Paper SI05PHUSE EU Connect 2019

SI05 Fake it Till You Make it with Global SDTM Laboratory Submissions

Éanna Kiely

Source category: Standards Implementation

Author collections: Éanna Kiely

PHUSE · 2019Paper SI06PHUSE EU Connect 2019

SI06 End-to-end SDTM Automation: A Metadata-centric Approach (winner)

Roman Radelicki

Source category: Standards Implementation

Author collections: Roman Radelicki

PHUSE · 2019Paper AD04PHUSE EU Connect 2019

The Trials and Tribulations of Automated SDTM Delivery

Edward Jones

Source category: Application Development

PharmaSUG · 2019Paper AD-109PharmaSUG 2019

Tool Development Methods for Implementing and Converting to New Controlled Terminology in SDTM datasets

Martha O’Brien; Keith Shusterman

Source category: Applications Development

Author collections: Martha O'Brien · Keith Shusterman

PHUSE · 2019Paper TT04PHUSE EU Connect 2019

TT04 Deconstructing SDTM – Starting Again

Johannes Ulander

Source category: Trends and Technology

Author collections: Johannes Ulander

PharmaSUG · 2019Paper AD-211PharmaSUG 2019

Validating Hyperlinks in SDTM define.xml Using Python

Brandon Welch; Greg Weller

Source category: Applications Development

Author collections: Brandon Welch

PharmaSUG · 2019Paper DS-311PharmaSUG 2019

What’s New in the SDTMIG v3.3 and the SDTM v1.7

Fred Wood

Source category: Data Standards

Author collections: Fred Wood

PharmaSUG · 2019Paper PO-130PharmaSUG 2019

When biomarker drives primary endpoint: An oncology case study of SDTM design using multiple myeloma.

Girish Kankipati; Bhargav Koduru

Source category: e-Posters

Author collections: Girish Kankipati · Bhargav Koduru

PHUSE · 2018Paper SI03PHUSE EU Connect 2018

A Critique of the Use of the Medical Device SDTM Domains in the Therapeutic Area User Guides

Carey Smoak

Source category: Standards Implementation

Author collections: Carey Smoak

PharmaSUG · 2018Paper MD08PharmaSUG 2018

A Critique of the Use of the Medical Device SDTM Domains in Therapeutic Area User Guides

Carey Smoak

Source category: Medical Devices

Author collections: Carey Smoak

PharmaSUG · 2018Paper SS03PharmaSUG 2018

A CRO’s perspective on successful partnering to deliver SDTM/SEND contributions

kirsty payne; Helen Owen

Source category: Submission Standards

SESUG · 2018Paper 238SESUG 2018

A Macro to Add SDTM Supplemental Domain to Standard Domain

Pratap Kunwar

Source category: Coders Corner

File inside source ZIP: Coders_Corner/SESUG2018_Paper-238_Final_PDF.pdf

Author collections: Pratap Kunwar

PHUSE · 2018Paper SI15PHUSE EU Connect 2018

A Proprietary CDASH/SDTM-hybrid Data Model to Expedite Clinical Data Review

Lieke Gijsbers; Tom Van Der Spiegel

Source category: Standards Implementation

Author collections: Lieke Gijsbers

SESUG · 2018Paper 177SESUG 2018

A User Defined SDTM Data Quality Checking and Tracking System

Zemin Zeng

Source category: Application Macro Development

File inside source ZIP: Application_Macro_Development/SESUG2018_Paper-177_Final_PDF.pdf

Author collections: Zemin Zeng

PharmaSUG · 2018Paper DS12PharmaSUG 2018

An alternate way to create the standard SDTM domains

Sunil Kumar Pusarla

Source category: Data Standards

Author collections: Sunil Kumar Pusarla