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trial summary

42 papers and 16 presentations; 56 titles.

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Conference × Year × Title × Authors Extras Pages
PHUSE US 2026 Optimising Trial Design Dataset Creation To Minimise P21 Compliance Issues Rama Kudaravalli source
presentation source		 6
PHUSE EU 2025 The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies Kristin Kelly source
presentation source		 8
PharmaSUG 2025 The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies Kristin Kelly source 9
PHUSE US 2025 The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies Kristin Kelly source
presentation source		 8
PHUSE US 2025 Using Large Language Models for Consistency Checking of Tables, Listings and Graphs Yingying Wei source
presentation source		 7
PharmaSUG 2024 A Programmer-s Insight into an Alternative to TQT Study Data Submission Hiba Najeeb,
Raghavender Ranga		 source 7
PharmaSUG 2024 Submitting Patient-Reported Outcome Data in Cancer Clinical Trials - Guidance for Industry Technical Specifications Document [presentation] Flora Mulkey source 48
PHUSE US 2024 ICH M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP) and CDISC: Making the Electronic Protocol a Reality [presentation] Peter Van Reusel source 33
PHUSE EU 2023 ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP) and CDISC: Making the Electronic Protocol a Reality [presentation] John Owen,
Peter Van Reusel		 source 33
PharmaSUG 2023 'TUFF' LOVE: SDTM Pain Points Explained! Kristin Kelly,
Michael Beers		 source 12
PharmaSUG 2023 Integrated Trial Design Model Datasets? Christine McNichol source 9
PHUSE US 2023 Enabling the Digital Data Flow from eProtocol to Downstream Processes [presentation] Berber Snoeijer,
Kumar Patel		 source
video		 13
PHUSE US 2023 Making Define-XML Work for You: Considerations in Supporting a Full Schema Implementation [presentation] Carlo Radovsky source 50
PHUSE EU 2022 Using Individual-level Real-world Data to Inform Disease Area Data Models Employed for Clinical Trial Simulation and Design [presentation] Sheila McCartan source
video		 41
PHUSE US 2022 FDA Study Data Technical Rejection Criteria (TRC): What You Need to Know! [presentation] Jiang Xu,
Lina Cong		 source
video		 26
PHUSE US 2022 Trial Design Datasets in Oncology Clinical Trials [presentation] Anastasiia Drach source
video		 23
PHUSE US 2022 Trial Summary SDTM Domain Made Easy for Regulatory Submissions [presentation] Kishore Pothuri source 16
PHUSE US 2021 FDA & PMDA Validator Rules - What, Why and How ... But Should You Care? [presentation] Charanjit Kahlon,
Kishore Pothuri		 source
video		 21
PHUSE US 2021 FDA Conformance Analysis and Upcoming Implementation of Technical Rejection Criteria for Study Data [presentation] Ethan Chen,
Heather Crandall		 source 36
PHUSE US 2021 Generating .xpt files with SAS, R and Python [presentation] Todd Case source
video		 22
PharmaSUG 2021 FDA Study Data Technical Rejection Update [presentation] Ethan Chen source 36
PharmaSUG 2021 Generating .xpt files with SAS, R and Python YuTing Tian,
Todd Case		 source 11
SGF 2021 Generating .xpt files with SAS, R and Python Todd Case source 11
PHUSE EU 2020 Getting It Right: Refinement of SEND Validation Rules [presentation] Kristin Kelly source
video		 29
PHUSE EU 2020 Poster PP03 Roman Radelicki source
video
poster source		 8
PHUSE EU 2020 SDTM Trial Summary Domain Puzzle: Are These the Right Pieces? [presentation] Kristin Kelly source
video		 24
PharmaSUG 2020 Data Review: What's Not Included in Pinnacle 21? Jinit Mistry,
Lyma Faroz,
Hao Meng		 source 7
PharmaSUG 2020 Ensuring Consistency Across CDISC Dataset Programming Processes Jennifer K. Fulton source 10
PHUSE US 2020 A Case Study: Data Transparency of Clinical Trial Data Sherry Meeh source
presentation source		 8
PHUSE US 2020 CDISC Library Try-out: From Implementation to Evaluation of the API Roman Radelicki source
presentation source		 9
PHUSE US 2020 Confusing Data Validation Rules Explained, Part 2 Michael Beers,
Blue Bell		 source 6
PHUSE US 2020 Creating a Simplified TS Domain Using the R Shiny App Hanming Tu source
presentation source		 11
PHUSE EU 2019 Automated Review of Metadata Standards, Data Checks and Trend Visualisation Giuseppe Di Monaco source
presentation source		 9
PHUSE EU 2019 TS does not mean T(o) S(uffer) - A hands-on guideline for a better understanding of the TS domain Kristina Zweier source
presentation source		 14
PharmaSUG 2019 Do-It-Yourself CDISC! A Case Study of Westat's Successful Implementation of CDISC Standards on a Fixed Budget Richard M. Mitchell,
Rachel Brown,
Jennifer K. Fulton,
Stephen Black,
Marie Byrd Alexander		 source 6
PharmaSUG 2019 The Need for Therapeutic Area User Guide Implementation Michael Beers source 8
PHUSE US 2019 CDISC Doesn't Tell You What to Collect But Regulators Do! Diane Wold source
presentation source		 4
PHUSE US 2019 The Need for Therapeutic Area User Guide Implementation Michael Beers source
presentation source		 7
PHUSE US 2018 Qualitative Analysis of Actual SEND Datasets for Trial Design Domains [poster] G. Sato source 1
PHUSE US 2018 SDTM and SEND: An Integrated View and Approach Veena Nataraj,
Cheryl Riel		 source
presentation source		 11
PharmaSUG 2018 Trial Summary: The Golden Gate towards a Successful Submission Bhargav Koduru,
Girish Kankipati		 source 9
PHUSE EU 2017 End-to-End Traceability from Protocol Development to Submission Mikkel Traun,
Trine Danø Klingberg		 source
presentation source		 3
PharmaSUG 2017 Building a Fast Track for CDISC: Practical Ways to Support Consistent, Fast and Efficient SDTM Delivery Steven R. Kirby,
Mario Widel,
Richard Addy		 source 14
PharmaSUG 2017 Considerations in Submitting Standardized Electronic Data Under the Animal Rule: The Use of Domains in the SDTMIG and the SENDIG Fred Wood source 7
PharmaSUG 2017 Quality Check your CDISC Data Submission Folder Before It Is Too Late! Bhavin Busa source 9
PharmaSUG 2016 SDTM Metadata: The Output is only as Good as the Input Sue Sullivan source 9
PharmaSUG 2016 SDTM Trial Summary Domain: Putting Together the TS Puzzle Kristin Kelly,
Jerry Salyers,
Fred Wood		 source 13
PharmaSUG 2016 The Standard for the Exchange of Nonclinical Data (SEND): History, Basics, and Comparisons with Clinical Data Fred Wood source 10
PharmaSUG 2016 Tips and tricks when developing Trial Design Model Specifications that provide Reductions in Creation time Ruth Marisol Rivera Barragan source 10
PharmaSUG 2015 Summing up - SDTM Trial Summary Domain Yi Liu,
Jenny Erskine,
Stephen Read		 source 9
PharmaSUG 2014 Considerations in Creating SDTM Trial Design Datasets Jerry Salyers,
Richard Lewis,
Kimberly Minkalis,
Fred Wood		 source 9
PHUSE EU 2013 The Evolution of SDTM - What's New Tina Apers source
presentation source		 5
SESUG 2011 Resolving OpenCDISC Error Messages Using SAS John R. Gerlach source 11
PharmaSUG 2011 Trials and Tribulations of SDTM Trial Design Fred Wood,
Mary Lenzen		 source 5
PharmaSUG 2011 Validating Controlled Terminology in SDTM Domains John R. Gerlach source 12
WUSS 2009 The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics Fred Wood source 9
PHUSE EU 2005 Visions of a Drug Development Data Warehouse Paul Vervuren source 7
SESUG 2004 Taking it Home and Putting it into Practice Diane Cunningham source 8

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