THE COMMUNITY ARCHIVE

SDTM Papers and PresentationsPage 17

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 321–340

PharmaSUG · 2016Paper DS15PharmaSUG 2016

Transforming Biomarker Data into an SDTM based Dataset

Kiran Cherukuri

Source category: Data Standards

Author collections: Kiran Cherukuri

PharmaSUG · 2016Paper BB16PharmaSUG 2016

UTF What? A Guide to Using UTF-8 Encoded Data in a SDTM Submission

Michael Stackhouse

Source category: Beyond the Basics

Author collections: Michael Stackhouse

PharmaSUG · 2015Paper BB03PharmaSUG 2015

A Toolkit to Create a Dynamic Excel Format Metadata to Assist SDTM Mapping Process

Huei-Ling Chen; Helen Wang

Source category: Beyond the Basics

Author collections: Huei-Ling Chen · Helen Wang

PharmaSUG · 2015Paper PO21PharmaSUG 2015

Evaluating SDTM SUPP Domain For AdaM – Trash Can Or Buried Treasure

Xiaopeng Li; Yi Liu; Chun Feng

Source category: Posters

Author collections: Xiaopeng Li · Chun Feng

PharmaSUG · 2015Paper BB17PharmaSUG 2015

Fresh Cup of Joe: Utilizing Java to automate Define.XML for SDTM Origin mapping from SAS® aCRF PDFs

Tony Cardozo

Source category: Beyond the Basics

Author collections: Tony Cardozo

PHUSE · 2015Paper SD02PHUSE EU Connect 2015

Implementation of an in-house Data QC Tool to Streamline SDTM Production Data

Karlien Knevels

Source category: Software Demonstrations

PHUSE · 2015Paper CD08PHUSE EU Connect 2015

Improving CDISC SDTM Data Quality & Compliance Right from the Beginning

Bharat Chaudhary; Padamsimh Balekundri

Source category: CDISC and Industry Standards

PharmaSUG · 2015Paper AD07PharmaSUG 2015

SDTM Annotations: Automation by implementing a standard process

Geo Joy; Andre Couturier

Source category: Applications Development

Author collections: Andre Couturier

PharmaSUG · 2015Paper DS02PharmaSUG 2015

SDTM TE, TA, and SE Domains: Demystifying the Development of SE

Kristin Kelly; Fred Wood; Jerry Salyers

Source category: Data Standards

Author collections: Kristin Kelly · Fred Wood · Jerry Salyers

PharmaSUG · 2015Paper PO14PharmaSUG 2015

Subset without Upsets: Concepts and Techniques to Subset SDTM Data

Jhelum Naik; Sajeet Pavate

Source category: Posters

Author collections: Jhelum Naik · Sajeet Pavate

PharmaSUG · 2015Paper PO10PharmaSUG 2015

Summing up – SDTM Trial Summary Domain

Yi Liu Celerion Inc.; Jenny Erskine Celerion Inc.; Stephen Read Celerion Inc.

Source category: Posters

Author collections: Yi Liu Celerion Inc. · Stephen Read Celerion Inc.

PHUSE · 2015Paper PP14PHUSE EU Connect 2015

The SAS Clinical Standards Toolkit - A Helpful Tool for Creating CDISC SDTM-compliant Study Data

Nicolai Haag

Source category: Poster Presentations

PHUSE · 2015Paper CD03PHUSE EU Connect 2015

Therapeutic Area Standards and their Impact on Current SDTM Implementations

Johannes Ulander; Niels Both

Source category: CDISC and Industry Standards

Author collections: Johannes Ulander · Niels Both

PharmaSUG · 2015Paper IB06PharmaSUG 2015

Two different use cases to obtain best responses using RECIST 1.1: SDTM and ADaM

Kevin Lee; Vikash Jain

Source category: Industry Basics

Author collections: Kevin Lee · Vikash Jain

PharmaSUG · 2014Paper CC14PharmaSUG 2014

A Toolkit to Check Dictionary Terms in SDTM

Huei-Ling Chen; Helen Wang

Source category: Coders Corner

Author collections: Huei-Ling Chen · Helen Wang

PharmaSUG · 2014Paper DS08PharmaSUG 2014

Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions Using SAS

Karin LaPann; Terek Peterson

Source category: Data Standards

Author collections: Karin LaPann · Terek Peterson

PharmaSUG · 2014Paper DS03PharmaSUG 2014

Considerations in Creating SDTM Trial Design Datasets

Jerry Salyers; Richard Lewis; Kim Minkalis; Fred Wood

Source category: Data Standards

Author collections: Jerry Salyers · Richard Lewis · Kim Minkalis · Fred Wood

PharmaSUG · 2014Paper DS04PharmaSUG 2014

Considerations in the Submission of Exposure Data in SDTM-Based Datasets

Fred Wood; Jerry Salyers; Richard Lewis; Kristin Kelly

Source category: Data Standards

Author collections: Fred Wood · Jerry Salyers · Richard Lewis · Kristin Kelly

PharmaSUG · 2014Paper DS05PharmaSUG 2014

Data Standards Development for Therapeutic Areas: A Focus on SDTM-Based Datasets

Fred Wood; Diane Wold; Rhonda Facile; Wayne Kubick

Source category: Data Standards

Author collections: Fred Wood · Diane Wold

PharmaSUG · 2014Paper DS02PharmaSUG 2014

Forging New SDTM Standards for In-Vitro Diagnostic (IVD) Devices: A Use-Case

Carey Smoak; Smitha Krishnamurthy; Mansi Singh; Sy Truong

Source category: Data Standards

Author collections: Carey Smoak · Smitha Krishnamurthy · Mansi Singh · Sy Truong