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cdisc controlled terminology

59 papers and 9 presentations; 66 titles.

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Conference × Year × Title × Authors Extras Pages
PharmaSUG 2026 SDTMIG v4.0: Are You Ready For It? Kristin Kelly source 12
PHUSE US 2026 SDTMIG v4.0: Are You Ready For It? Kristin Kelly source
presentation source		 10
PharmaSUG 2025 A Little Bit of This and That: Use cases, implementation, and documentation when using multiple CDISC standards, CTs, and regulatory guidances in an SDTM study Charity Quick source 14
PharmaSUG 2025 ADaM Pet Peeves: Things Programmers Do That Make Us Crazy Sandra Minjoe,
Nancy Brucken		 source 13
PharmaSUG 2025 Change the way you think of Codelist - Optimize managing Organization Controlled Terminology with a meta-model and its features to manage Codelist in MDR Kairav Tarmaster source 11
PharmaSUG 2025 Efficient CDISC Controlled Terminology Mapping: An R-Based Automation Solution Yunsheng Wang source 8
PharmaSUG 2025 Enhancing Dictionary Management and Automation with NCI EVS: A Deeper Dive for the CDISC Community Anthony Chow source 6
PharmaSUG 2025 Guidance from the FDA authored "Submitting Patient-Reported Outcome Data in Cancer Clinical Trials" and recommendations for their implementation in study CDISC COA data. Charity Quick source 14
PHUSE EU 2024 The TransCelerate/CDISC Digital Data Flow Project: Practical Electronic Study Designs [presentation] David Iberson-Hurst source 8
PHUSE EU 2023 A Dive Into the World of Biomedical Concepts Berber Snoeijer source
presentation source		 5
PHUSE EU 2023 Open-Source MDR and SDR - Managing Your Standards with the OpenStudyBuilder Nicolas De Saint Jorre,
Mikkel Traun		 source
presentation source		 13
PHUSE EU 2023 The role of FHIR Resources in ensuring Semantic Equivalence in EHR2EDC direct data capture Patrick Genyn source
presentation source		 4
PHUSE US 2023 SDTM Mapping Recommendation Engine - Acorn [presentation] Rohan Parmar,
Harshit Manektalia		 source
video		 32
PHUSE EU 2022 Cross-functional Standardisation of Controlled Terminologies Through Knowledge Graphs [presentation] Daniela Bergann,
Ena Kolundzic		 source
video		 15
PHUSE EU 2022 From Silos to Knowledge [presentation] David Iberson-Hurst source 16
PharmaSUG 2022 Damn*t, The Define! Julie Ann Hood,
Sarah Angelo		 source 16
PharmaSUG 2022 Sponsor-defined Controlled Terminologies: A Tiny Key to a Big Door Shefalica Chand source 15
PHUSE EU 2021 Integrated Summary of Safety and Efficacy Production Strategies Navneet Agnihotri,
Sumit Pratap Pradhan		 source
video
presentation source		 9
PHUSE EU 2021 Next Generation MDR Solution for Study Design and Configuration Using Concept-based Standards [presentation] Mikkel Traun source
video		 15
PHUSE US 2021 Controlled Terminology Best Practices [presentation] Sarah Angelo source
video		 29
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 Industry Metrics for Extensions of CDISC Terminology [presentation] Sergiy Sirichenko source
video		 36
PHUSE US 2021 Pinnacle 21: Improving the Data Fitness Score for eSubmission Renu Motwani source
video
presentation source		 9
PHUSE EU 2020 Poster PP03 Roman Radelicki source
video
poster 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 Giving Back to the Community - Managing CDISC Terminology Dorte Straarup source
poster source		 1
PHUSE US 2020 Lab Master List File Makes Easy Clio Wu source
presentation source		 7
PharmaSUG 2019 Automate the Process to Ensure the Compliance with FDA Business Rules in SDTM Programming for FDA Submission Xiangchen (Bob) Cui,
Hao Guan,
Min Chen,
Letan (Cleo) Lin		 source 16
PharmaSUG 2019 The Need for Therapeutic Area User Guide Implementation Michael Beers source 8
PharmaSUG 2019 Tool Development Methods for Implementing and Converting to New Controlled Terminology in SDTM datasets Martha O'Brien,
Keith Shusterman		 source 10
PHUSE EU 2018 AI-powered Xbiom 3.1 Smart Curation & Transformation of Data [presentation] Kurien Abraham,
Nicolas Philippe		 source 12
PHUSE EU 2018 Best Practice for Explaining Validation Results in the Study Data Reviewer's Guide Kristin Kelly,
Michael Beers		 source
presentation source		 8
PHUSE EU 2018 Diagnostics of technical errors in define.xml file Sergiy Sirichenko,
Max Kanevsky		 source
presentation source		 9
PHUSE EU 2018 From Machine-readable CDISC Standard Specifications to the e-Protocol Jozef Aerts source
presentation source		 8
PHUSE EU 2018 How to Manage Changes to CDISC Standards Sune Dandanell,
Mikkel Traun		 source
presentation source		 4
PHUSE EU 2018 The "CDISC Stupidario" (the CDISC Nonsense) Angelo Pinazzi source
poster source		 11
PHUSE US 2018 Optimizing SDTM Specification Development with Auto-population Cori Kramer,
Ryan Adalbert		 source
presentation source		 6
PharmaSUG 2018 Diagnostics of technical errors in define.xml file Sergiy Sirichenko,
Max Kanevsky		 source 9
PharmaSUG 2018 It's all about getting the Source and Codelist Implementation right for ADaM Define.xml v2.0 Supriya Davuluri source 11
PHUSE EU 2017 Define.xml Tools Supporting SEND/SDTM Data Process Kirsten Langendorf source
presentation source		 14
PHUSE EU 2017 Implementing a Meta-data Repository (MDR) Using Functional Service Provider (FSP) How Does it Work? Carla Santillán source
presentation source		 12
PHUSE EU 2017 Use of Fast Healthcare Interoperability Resources (FHIR) in the Generation of Real-World Evidence Trisha Simpson,
Regina Zopf		 source
presentation source		 12
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 Good Data Validation Practice Sergiy Sirichenko,
Max Kanevsky		 source 10
PharmaSUG 2017 Harmonizing CDISC Data Standards across Companies: A Practical Overview with Examples Keith Shusterman,
Prathima Surabhi,
Binoy Varghese		 source 6
PharmaSUG 2017 Planning to Pool SDTM by Creating and Maintaining a Sponsor-Specific Controlled Terminology Database Cori Kramer,
Ragini Hari,
Keith Shusterman		 source 7
PharmaSUG 2017 Usage of Pinnacle 21 Community Toolset 2.x.x for Clinical Programmers Sergiy Sirichenko,
Michael DiGiantomasso		 source 23
PHUSE EU 2016 Use of Fast Healthcare Interoperability Resources (FHIR) in the Generation of Real World Evidence (RWE) Regina Zopf,
Jeffrey M. Abolafia,
Bhargava Reddy		 source
presentation source		 12
PHUSE EU 2016 What is high quality study metadata? Sergiy Sirichenko,
Max Kanevsky		 source
presentation source		 9
PharmaSUG 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 24
PharmaSUG 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 13
PharmaSUG 2016 Codelists Here, Versions There, Controlled Terminology Everywhere Shelley Dunn source 12
PharmaSUG 2016 Usage of Pinnacle 21 Community Toolset 2.1.1 for Clinical Programmers Sergiy Sirichenko,
Michael DiGiantomasso,
Travis Collopy		 source 19
PharmaSUG 2016 What is high quality study metadata? Sergiy Sirichenko,
Max Kanevsky		 source 9
PharmaSUG CN 2015 Tips for efficient CDISC eCRT production Lanting Li,
Yu Zhu,
Yuejuan Meng,
Huan Zhu		 11
PharmaSUG 2015 Begin with the End in Mind - Using FDA Guidance Documents as Guideposts when Planning, Delivering and Archiving Clinical Trials David C. Izard source 12
PharmaSUG 2015 The Most Common Issues in Submission Data Sergiy Sirichenko,
Max Kanevsky		 source 9
PharmaSUG 2015 Usage of OpenCDISC Community Toolset 2.0 for Clinical Programmers Sergiy Sirichenko,
Michael DiGiantomasso,
Travis Collopy		 source 19
PharmaSUG 2014 Challenges in Processing Clinical Lab Data Alan Meier source 15
PharmaSUG 2014 Developing ADaM Specifications to Embrace Define-XML 2.0.0 Requirements Lin Yan source 10
PharmaSUG 2014 OpenCDISC Validator Implementation: A Complex Multiple Stakeholder Process Terek J. Peterson,
Gareth Adams		 source 9
PharmaSUG 2014 SDTM, ADaM and define.xml with OpenCDISC Angela S. Ringelberg,
Tracy Sherman		 source 21
PHUSE EU 2013 Considerations in the Submission of Holter (EG) Data in an SDTM Compliant Format Elsa Lozachmeur,
Sophie Arnould		 source
presentation source		 7
PharmaSUG 2013 Programming Validation Tips prior to using OpenCDISC validator Dany Guerendo source 12
PharmaSUG 2012 Clinical Laboratory Results, Old and New Pains Mario Widel,
Scott A. Bahlavooni		 source 6
PharmaSUG 2012 Considerations in the Submission of Pharmacokinetics (PK) Data in an SDTM-Compliant Format Fred Wood,
Peter Schaefer,
Richard Lewis		 source 8
PHUSE EU 2009 Experiences and lessons learned from a first SDTM submission project Paul Vervuren,
Bas van Bakel		 source
presentation source		 12
PharmaSUG 2009 Using CDISC Lab Terminology and Determining Standard Units Matthew Davis 7

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