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48 papers and 3 presentations; 49 titles.

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Conference × Year × Title × Authors Extras Pages
PharmaSUG 2026 Bridging the Gap: Table-Driven SAS Programming as a Pathway to AI in Clinical Trials Statistical Programming James Sun,
Vijaya Nadella,
Daniel Qi		 source 15
PharmaSUG 2026 Practical Lessons in AI-Assisted Metadata Conversion: From Database Specs to EDC and SDTM - Successes, Pitfalls, and Practical Implementation Jianlin Li,
Andy Shen		 source 11
PHUSE EU 2024 Associated Patient Mapping in SDTM Sadiya Ait M'Bark source
poster source		 2
PHUSE EU 2024 Guidance Beyond the SDTM Implementation Guide Kristin Kelly source
presentation source		 10
PharmaSUG 2024 Guidance Beyond the SDTM Implementation Guide Kristin Kelly,
Michael Beers		 source 11
PHUSE US 2024 Guidance Beyond the SDTM Implementation Guide Michael Beers,
Blue Bell		 source
presentation source		 10
PharmaSUG 2023 'TUFF' LOVE: SDTM Pain Points Explained! Kristin Kelly,
Michael Beers		 source 12
PHUSE EU 2022 Maturing standardisation; the switch from spreadsheet-based standards to an MDR Louella Schoemacher,
Jasmine Kestemont		 source
presentation source		 5
PharmaSUG 2022 A Dynamic Data Visualization Report for Efficacy Endpoints of Early Oncology Study Hong (Lily) Zhang,
Yixin Ren,
Huei-Ling Chen		 source 10
PHUSE EU 2021 A case of mistaken ID: reimagining rescreenings and reenrollments Matt Metherell source
video
presentation source		 5
PharmaSUG 2021 Multiple Successful Submissions of Medical Device Clinical Trial Data in the US and China using CDISC Phil Hall,
Tikiri B. Karunasundera,
Subendra Maharjan,
Vijaya Vegesna		 source 10
PharmaSUG 2021 Types of Devices in Therapeutic Area User Guides Carey G. Smoak source 7
PHUSE EU 2020 Goodbye, Excel, My Old Friend: A Collaboration Between Sanofi and S-cubed [presentation] David Iberson-Hurst,
Karen Fanouillere		 source
video		 19
PHUSE EU 2020 One Boy's Dream: Hitting a Homerun in the Bottom of the Ninth Inning [presentation] Carey G. Smoak source
video		 23
PHUSE EU 2020 Poster PP03 Roman Radelicki source
video
poster source		 8
PHUSE EU 2020 The Good? The Bad? Or the Ugly? CDISC eSubmission Packages in Practice [presentation] Artur Krupa source
video		 26
PharmaSUG 2020 Successful US Submission of Medical Device Clinical Trial using CDISC Phil Hall source 6
PHUSE US 2020 CDISC Implementation Primer Bess LeRoy,
Rebecca Baker		 source 5
PHUSE US 2020 CDISC Library Try-out: From Implementation to Evaluation of the API Roman Radelicki source
presentation source		 9
PHUSE EU 2019 Mapping Raw Data to SDTM Define Using the SAS Clinical Standards Toolkit Andrew Bullivant source
presentation source		 7
MWSUG 2019 Findings About: De-mystifying the When and How Michael Wise,
Soumya Rajesh		 9
PharmaSUG 2019 Findings About: De-mystifying the When and How Soumya Rajesh,
Michael Wise		 source 9
PHUSE US 2019 Removing Silos: Placing Data at the Center David Iberson-Hurst source
presentation source		 9
PHUSE EU 2018 A Critique of the Use of the Medical Device SDTM Domains in the Therapeutic Area User Guides Carey G. Smoak source
presentation source		 8
PharmaSUG 2018 A Critique of the Use of the Medical Device SDTM Domains in Therapeutic Area User Guides Carey G. Smoak source 10
PharmaSUG 2018 SDTMs in a Medical Device Trial - A First Attempt Phil Hall source 6
WUSS 2017 SDTMs in a Medical Device Trial - A First Attempt Phil Hall source 5
PHUSE EU 2016 Assessing CDISC Therapeutic Area User Guides in a Machine Readable Format Johannes Ulander,
Niels Both		 source
presentation source		 4
PHUSE EU 2016 Fast Track to Domain: SDTM.PC and SDTM.PP Lina Ulkjær Jørgensen source
presentation source		 2
WUSS 2016 A Case of Retreatment - Handling Retreated Patient Data Sriramu Kundoor,
Seattle Genetics,
Sumida Urval		 source 4
PHUSE EU 2015 Are Your Ready for SEND? Roman Radelicki source
presentation source		 8
PHUSE EU 2015 Finding Out about Findings About Carolina Clark-Steel source
presentation source		 2
PHUSE EU 2015 Therapeutic Area Standards and their Impact on Current SDTM Implementations Johannes Ulander,
Niels Both		 source
presentation source		 6
PharmaSUG 2015 Considerations in Submitting Non-Standard Variables: Supplemental Qualifiers, Findings About, or a Custom Findings Domain Jerry Salyers,
Richard Lewis,
Fred Wood		 source 6
PHUSE EU 2014 Handling Non-Standardised Questionnaires Anne Sophie Beckx,
Éanna Kiely		 source
presentation source		 5
PHUSE EU 2014 How the Release of the Therapeutic Area Asthma User Guide Affects an Ongoing Submission Nick De Donder source
presentation source		 6
PharmaSUG 2014 Referencing Medical Device Data in Standard SDTM domains Timothy L Bullock,
Ramkumar Krishnamurthy		 source 7
PharmaSUG 2013 Considerations in Data Modeling when Creating Supplemental Qualifiers Datasets in SDTM-Based Submissions Fred Wood source 12
PharmaSUG 2013 Mapping Unique Aspects of Implantable Medical Device Study Data to CDISC SDTM Medical Device Domains Timothy L Bullock,
Sini Nair,
Ramkumar Krishnamurthy,
Todd M. Gross		 source 12
PHUSE EU 2012 An Introduction to SDTM, 298 Pages in 20 Minutes? Jennie McGuirk source
presentation source		 8
PharmaSUG 2012 Seven New SDTM Domains for Medical Devices Carey G. Smoak,
Fred Wood,
Rhonda Facile,
Kit Howard		 source 4
PHUSE EU 2011 SDTM Domain QS: Challenges and Pitfalls - an Interpretation Guide to the Implementation Guide Knut Mueller source
presentation source		 6
PHUSE EU 2011 SDTM Implementation Guide - Clear as Mud: Strategies for Developing Consistent Company Standards Brian Mabe source
presentation source		 5
PharmaSUG 2011 A Cost-Effective SDTM Conversion for NDA Electronic Submission Xiangchen (Bob) Cui,
Scott E. Moseley,
Min Chen		 source 12
PHUSE EU 2008 In at the Deep-End (thoughts on mapping multiple studies into CDISC for an ISS/ISE) Andrew Noller source 7
PharmaSUG 2008 SAS, CDISC and Clinical Data Integration Peter Villiers 27
SGF 2008 Practical Methods for Creating CDISC SDTM Data Sets from Existing Data Robert W. Graebner source 11
PharmaSUG 2007 CDISC for the Medical Device and Diagnostic Industry Carey G. Smoak 4
PharmaSUG 2007 Evolution and Implementation of the CDISC Study Data Tabulation Model (SDTM) PharmaSUG Annual Meeting,
Fred Wood,
Tom Guinter		 47
PharmaSUG 2007 Strategies and Practical Considerations for Creating CDISC SDTM Domain Data Sets from Existing CDM Data Sets Robert W. Graebner 12
NESUG 2006 Standard SAS Macros for Standard Date/Time Processing Qin Lin,
Timothy D. Kelly		 18

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