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297 papers and 23 presentations; 305 titles.

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Conference × Year × Title × Authors Extras Pages
WUSS 2026 A Flexible Metadata-Driven and Modular Approach to SDTM Automation [presentation] Ruili Shi,
Jiaying Zhang,
Charles Chen		 source 15
PharmaSUG CN 2026 From SAP to TFL: An AI-Assisted Workflow Framework for Automated Shells and TFLs Xiaoyu Ding,
Guoqing Zhao,
Huafeng Gao,
Zhiyuan Guo		 source 18
PharmaSUG CN 2026 From Spreadsheets to Smart Platforms: A Framework for Modernizing SDTM Specification Management Using the Microsoft 365 Ecosystem Shuting Lou source 14
PharmaSUG 2026 Accelerating CDISC SEND Conversion with AI: From Raw Preclinical Data to Regulatory-Ready Datasets Nattawit Pewngam,
Chotika Chatgasem,
Titipat Achakulvisut		 source 10
PharmaSUG 2026 Closing the Loop: Validating AI-Generated SDTM Mappings using CDISC CORE and Synthetic Data Pietro Belligoli,
Constantin Weberpals,
Yarhy Flores Lopez		 source 7
PharmaSUG 2026 From Manual to Automated": An SAS and R-Based Toolkit for Scalable SDTM Generation Hardik Sheth,
Eldho Alias		 source 8
PharmaSUG 2026 Goodbye SAS, Hello R: Practical Workflows for CDISC Standards Madeleine Penniston,
Alyssa M. Wittle		 source 12
PharmaSUG 2026 Navigating Early Career Challenges in PK/ADA Statistical Programming Diyu Yang,
Sandeep Meesala		 source 11
PharmaSUG 2026 Ready for Next Level SDTMs and ADaMs Compliance with End-to-End Processing? Sunil Kumar Gupta,
Tomás Sabat Stofsel		 source 6
PharmaSUG 2026 SUPP to NSV: Transforming Data Representation for Improved Reviewer Utility Soumya Rajesh source 10
PharmaSUG 2026 Virtual Data, Real Standards: Leveraging Data Simulation for Smarter Clinical Trials Sangeeta Shabadi,
Nitesh Patil,
Jonathan Henshaw		 source 16
PHUSE US 2026 Beyond the Hype: Practical Guidance for LLM Adoption in Statistical Programming Michael Goedde source
presentation source		 9
PHUSE US 2026 Building Cross-Functional Regulatory and Programming Alignment for Successful Submissions Ben Kaspar,
Stephine Keeton		 source
presentation source		 6
PHUSE US 2026 Case Study: Leveraging CDISC CORE for Proactive SDTM Compliance and Submission Readiness Shivani Gupta source
presentation source		 6
PHUSE US 2026 Data Harmonisation for ISS and ISE: A Practical Checklist for Integration Success Qiong Wei,
Lily Cheng		 source
presentation source		 10
PHUSE US 2026 Enhancing Clinical Trial Dataset Mapping with AI/ML Techniques: An Approach for CDISC Variable Prediction Parvee Kumar source
presentation source		 7
PHUSE US 2026 From System Exports to Standards: Will Standardisation of External Vendor Data Redefine Clinical Data Management/Analysis? Sai Sri Sravya Deevi source
presentation source		 5
PHUSE US 2026 Harnessing LLM-Augmented Automation for ADaM Dataset Generation Anil Mogha,
Ghourav Garg		 source
presentation source		 9
PHUSE US 2026 Leveraging Python for Synthetic External Vendor Data Generation for eCOA and ePRO Hitesh Raval source
presentation source		 9
PHUSE US 2026 Metadata-Driven TFL Generation: End-to-End Automation from Protocol to Output Bill Qubeck source
presentation source		 12
PHUSE US 2026 Multiple Sclerosis Trials Unpacked: Standards, Endpoints and Programming Experience Daryna Teteriuk source
presentation source		 12
PHUSE US 2026 Optimising Trial Design Dataset Creation To Minimise P21 Compliance Issues Rama Kudaravalli source
presentation source		 6
PHUSE US 2026 Ready for Next-Level SDTM and ADaM Compliance with End-to-End Processing? Sunil Kumar Gupta source
presentation source		 4
PHUSE US 2026 Submitting eCRT SDTM Data for ISS Aida Swierk source
presentation source		 10
PHUSE APAC 2026 Automation and Macros in Clinical Submissions: Challenges, Limits and the Path Forward Bharath Kumar Malipeddi source
presentation source		 3
PHUSE APAC 2026 Creating a clinical trial data package for Regulatory submission Pradip Sivaramakrishnan,
Anbarasan Durairajan		 source
poster source		 11
PHUSE APAC 2026 E2E Clinical Metadata Journey: 'Single Source of Truth' to Accelerate Clinical Research - From Collection and Tabulation to Analysis and Reporting Indumathi Narasetty source
presentation source		 9
PHUSE APAC 2026 Implementing the CDISC Library RESTful API in R: Automated Access to Metadata Repositories and Controlled Terminologies Jagadish Katam source
presentation source		 11
PHUSE APAC 2026 Optimising Pinnacle 21 Compliance with Automated Metadata Updates Karthik Palani source
presentation source		 7
PHUSE APAC 2026 Standardization of Auxiliary Medicinal Products (AxMPs) in Clinical Trials Divya Mekala,
Manoj Mishra		 source
presentation source		 3
PHUSE APAC 2026 Streamlining SEND Dataset Generation: Enhancing Efficiency and Quality with Shiny Dashboards Madhulika Mishra,
Michael Denieu		 source
presentation source		 10
PHUSE EU 2025 How to map lab data into the LB domain and ADLB Bert Parmet source
poster source		 6
PHUSE EU 2025 Launching CDISC CORE v1.0: A New Standard for Automated Study Conformance [presentation] Tomás Sabat Stofsel,
Nick De Donder		 source 44
PHUSE EU 2025 Qualitative ADaM Datasets and Define-XML Without Using ADaM Specs Pieter Coppens source
presentation source		 4
PHUSE EU 2025 Turning Data into Deliverables: Automating Biometrics from Metadata to TFLs Inderjeet Arora source
presentation source		 9
PHUSE EU 2025 Why Wait for Real Data? The Power of Synthetic Data in Modern Clinical Trials Abhijeet Arora source
presentation source		 6
PharmaSUG 2025 ADaM Pet Peeves: Things Programmers Do That Make Us Crazy Sandra Minjoe,
Nancy Brucken		 source 13
PharmaSUG 2025 Does SDTM Validation Really Require Double Programming? Sunil Kumar Gupta,
Tomás Sabat Stofsel		 source 5
PharmaSUG 2025 Elevating Clinical Research: Strategic Implementation of CDASH and SDTM Standards Hayden Patel source 4
PharmaSUG 2025 Enhancing Dictionary Management and Automation with NCI EVS: A Deeper Dive for the CDISC Community Anthony Chow source 6
PharmaSUG 2025 Running the CDISC Open Rules Engine (CORE) in BASE SAS Lex Jansen source
presentation		 40
PharmaSUG 2025 Updating Define-XML packages: Tips and A Comprehensive Checklist Qiong Wei,
Ji Qi,
Lixin Gao		 source 10
PHUSE US 2025 Evolution of Genomic Data Mapping from PF to GF in SDTM v3.4: Concepts, Challenges and Controlled Terminology with Genetic Variation Examples Rama Kudaravalli source
presentation source		 7
PHUSE US 2025 Optimising SDTM and ADaM: Remediation Techniques for Data Accuracy Kishore Pothuri source
presentation source		 10
PHUSE US 2025 When and Why You Should Deviate from CDASH Standards Agnes Nkenglefac Akawung,
Trevano Dean		 source
poster source		 2
PHUSE EU 2024 From Source to Submission: Getting the Best of Multiple Standards Jules Van der Zalm,
Berber Snoeijer		 source
presentation source		 4
PHUSE EU 2024 Harmonising FDA and PMDA Submission Requirements Luca Semeraro source
presentation source		 12
PHUSE EU 2024 Mastering Pinnacle 21 for Oncology SDTM Daryna Khololovych source
presentation source		 7
PHUSE EU 2024 The TransCelerate/CDISC Digital Data Flow Project: Practical Electronic Study Designs [presentation] David Iberson-Hurst source 8
PHUSE EU 2024 Tips and Tricks: From Specification to Define.xml v2.1 using SAS Caroline Pelckmans source
presentation source		 18
PharmaSUG CN 2024 Introduction of Ophthalmic Examinations and the Preparation of SDTM OE Using SDTM IG 3.3 Shuang Qiu source 15
PharmaSUG 2024 aCRF Copilot: Pioneering AI/ML Assisted CRF Annotation for Enhanced Clinical Data Management Efficiency Chaitanya Pradeep Repaka,
Santhosh Karra		 source 7
PharmaSUG 2024 Externally Yours - Adeptly Managing Data Outside Your EDC System Frank Canale source 38
PharmaSUG 2024 Managing a Single Set of SDTM and ADaM Specifications across All Your Phase 1 Trials Avani Kaja source 5
PharmaSUG 2024 Submitting Patient-Reported Outcome Data in Cancer Clinical Trials - Guidance for Industry Technical Specifications Document [presentation] Flora Mulkey source 48
PharmaSUG 2024 Variable Subset Codelist Kang Xie source 7
PharmaSUG 2024 Your Guide to Successfully Upversioning CDISC Standards David Neubauer,
Kapila Patel,
Toral Patel,
Soumya Rajesh		 source 19
PHUSE US 2024 Digitisation of Specifications - Brave New World for Analysis Definitions Rebecca Bates,
Krishna Gopal		 source
presentation source		 6
PHUSE US 2024 Effective Workflow Process: Rapid SDTMs and Compliance Dashboards Sunil Kumar Gupta,
Harinarayan Gopichandra		 source
poster source		 5
PHUSE US 2024 Getting More Efficiency from your Instruments Using CDISC Franklin E. Menius source
presentation source		 5
PHUSE US 2024 How to Monitor SDTM Data Health Amanda Cross source
presentation source		 8
PHUSE EU 2023 Automated Pipelines for Non-CRF Value Level Metadata, A Meta-programming Approach Selena Baset,
Philipp Ernst,
Didier Clément		 source
presentation source		 10
PHUSE EU 2023 Enhancing the Quality of Data Harmonisation - a Customisable Tool for Validation of Bespoke SDTM Implementation at the Infectious Diseases Data Observatory (IDDO) [poster] Sadie Kelly,
Dick Hung		 source 1
PHUSE EU 2023 Open-Source Protocol Automation with the OpenStudyBuilder Nicolas De Saint Jorre,
Mikkel Traun		 source
presentation source		 9
PHUSE EU 2023 Standardisation in a fast growing environment; MDR, EDC and other abbreviations Louella Schoemacher,
Jasmine Kestemont		 source
presentation source		 6
PHUSE EU 2023 Submission Standards for Real-World Data: Gaps, Limitations and Recommendations Jeffrey M. Abolafia,
Sarah Ferko,
Ingeborg Holt		 source
presentation source		 8
PharmaSUG 2023 Better CDISC Standards with Metadata Programming Sunil Kumar Gupta,
Abhishek Dabral		 source 14
PharmaSUG 2023 CDISC Conformance and Compliance: So Many Resources, So Little Time! Jennifer K. Fulton,
Stephen Black		 source 11
PharmaSUG 2023 Digital Data Flow (DDF) and Technological Solution Providers Prasoon Sangwan,
Piyush K. Singh		 source 8
PharmaSUG 2023 FDA's Study Data Policy Framework and How CDISC Properties Are Evaluated for Inclusion Helena Sviglin source 20
PharmaSUG 2023 Proposal for New ADaM Paired Variables: PARQUAL/PARTYPE Elizabeth Dennis,
Monika Kawohl,
Paul K. Slagle		 source 7
PharmaSUG 2023 Regulatory Data Submission and CDISC Compliance: Sponsor and Vendor Collaboration Best Practices Tabassum Ambia source 5
PHUSE US 2023 EDC Raw Data to SDTM Curation, Mapping and Automation with XBiom Tool Sunil Kumar Gupta,
Rahul Madhavan		 source
presentation source		 7
PHUSE US 2023 Say No to Stale Data!! Implementation of Automated GxP Data Pipelines Using KNIME [presentation] Shiva Katepalli,
Jeffrey Xiong		 source
video		 30
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 Data From the Clouds ... and Back Again John McDade source
presentation source		 12
PHUSE EU 2022 Modelling Electrocardiogram Waveform Interpretations for SEND Submissions [poster] Jack Baker source 1
PHUSE EU 2022 Overcoming Challenges of Your Integrated Summary ISS/ISE Submissions Jenet Cp,
Akhil Vijayan		 source
presentation source		 7
PHUSE EU 2022 The Development of CDISC Biomedical Concepts: Update and Next Steps [presentation] Bess LeRoy source
video		 35
PharmaSUG 2022 A Shiny App to Spell Check an ADaM Specification Simiao Ye,
Jeff Xia		 source 9
PharmaSUG 2022 Real Time Oncology Review Readiness from Programming Perspective Binal Mehta,
Patel Mukesh		 source 10
PharmaSUG 2022 Sponsor-defined Controlled Terminologies: A Tiny Key to a Big Door Shefalica Chand source 15
PHUSE US 2022 A Practical Exploration of SEND for CBER Submissions Jack Baker source
presentation source		 11
PHUSE US 2022 Trial Summary SDTM Domain Made Easy for Regulatory Submissions [presentation] Kishore Pothuri source 16
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 EU 2021 Utilising LSAF for Data Management at a Belgian Biotech Louella Schoemacher source
video
presentation source		 7
PHUSE US 2021 An R-based Tool to Build Questionnaires, Ratings and Scales (QRS) in EDC for Clinical Trials [presentation] Catherine Abogado,
Rammprasad Ganapathy		 source
video		 19
PHUSE US 2021 Challenges and Solutions in SDTM Implementation and Programming of the Ophthalmic Examinations (OE) Domain [presentation] Shivam Kumar,
Vinita Dora		 source
video		 16
PHUSE US 2021 Controlled Terminology Best Practices [presentation] Sarah Angelo source
video		 29
PHUSE US 2021 Pinnacle 21: Improving the Data Fitness Score for eSubmission Renu Motwani source
video
presentation source		 9
PHUSE US 2021 VALSPEC Utility to Validate CDISC Specifications [presentation] Aman Bahl,
Hrideep Antony		 source
video		 12
PharmaSUG 2021 Customizing define.xml files Steffen Müller source 9
PharmaSUG 2021 Generating FDA-ready Submission Datasets directly from EHRs Jozef Aerts source 9
PharmaSUG 2021 Generating Synthetic CDISC Clinical Trial Data. Jose C. Lacal source 14
PharmaSUG 2021 SEND for CBER Lisa Lin source 26
PharmaSUG 2021 Validation of CDISC specifications using VALSPEC utility macro Hrideep Antony,
Aman Bahl		 source 8
PHUSE EU 2020 Defining Standards: Challenges and Solutions in the Development of Define-XML for SDTM and ADaM Sofia Vale source
video
poster source		 9
PHUSE EU 2020 Getting It Right: Refinement of SEND Validation Rules [presentation] Kristin Kelly source
video		 29
PHUSE EU 2020 Let CDISC Be Roxane Debrus,
Silvia Faini		 source
video
presentation source		 8
PHUSE EU 2020 Poster PP03 Roman Radelicki source
video
poster source		 8
PharmaSUG 2020 A Novel Solution for Converting Case Report Form Data to SDTM using Configurable Transformations Sara Shoemaker,
Matthew Martin,
Robert Kleemann,
David Costanzo,
Tobin Stelling		 source 12
PharmaSUG 2020 Creating SDTMs and ADaMs CodeList Lookup Tables Sunil Kumar Gupta source 8
PharmaSUG 2020 Data Review: What's Not Included in Pinnacle 21? Jinit Mistry,
Lyma Faroz,
Hao Meng		 source 7
PharmaSUG 2020 Supplementary Steps to Create a More Precise ADaM define.xml in Pinnacle 21 Enterprise Majdoub Haloui,
Hong Qi		 source 10
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 Data Standards for eCOA in Clinical Trials Terek Peterson,
Franklin E. Menius		 source
presentation source		 6
PHUSE US 2020 Developing SEND for CBER - Collaborative Workstream Initiative Update Lisa Lin,
Susan DeHaven		 source
presentation source		 6
PHUSE US 2020 Early Detection and Prevention of Compliance Issues Vara Prasad Reddy Sakampally source 5
PHUSE US 2020 Giving Back to the Community - Managing CDISC Terminology Dorte Straarup source
poster source		 1
PHUSE US 2020 Standardization = Automation: A Journey from Dataset Specification to SAS Code Anastasiia Khmelnytska source
presentation source		 11
PHUSE EU 2019 Automating the blankcrf.pdf and define.xml with your database build John McDade source
poster source		 6
PHUSE EU 2019 Implementation of SDTM IG v.3.3 for Neurological Therapeutic Area Daryna Khololovych source
presentation source		 7
PHUSE EU 2019 Implementing the CDISC Library API in Software Applications: First Experiences Jozef Aerts source
presentation source		 7
PHUSE EU 2019 Macro-enabled Trial Design Domain Specification Template [poster] Chintankumar Patel source 1
PHUSE EU 2019 Making data mapping process easier and smarter with SAS and R Andrii Artemchuk source
presentation source		 10
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 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 Best Practices in Data Standards Governance Melissa R. Martinez source 4
PharmaSUG 2019 Common Pinnacle 21 Report Issues: Shall we Document or Fix? Ajay Gupta source 11
PharmaSUG 2019 Considerations and Updates in the Use of Timing Variables in Submitting SDTM-Compliant Datasets Jerry Salyers source 9
PharmaSUG 2019 Exploring Common CDISC ADaM Conformance Findings Trevor Mankus source 6
PharmaSUG 2019 Have You Met Define.xml 2.0? Christine McNichol source 15
PharmaSUG 2019 Practical Guidance for ADaM Dataset Specifications and Define.xml Jack Shostak source 14
PharmaSUG 2019 Practices in CDISC End-to-End Streamlined Data Processing Chengxin Li source 14
PHUSE US 2019 A Linked Data Model and Hypermedia API for CDISC Share 2.0 Samuel Hume,
Frederik Malfait		 source 12
PHUSE US 2019 CDISC in Phase I/II Studies: Case Studies in Adopting Standards Emily Woolley,
Amber Randall Scharp		 source
presentation source		 7
PHUSE US 2019 Developing SEND for CBER - Collaborative Workstream Initiative Lisa Lin,
Susan DeHaven		 source
presentation source		 6
PHUSE US 2019 Expectations and Collaboration - Recipe for Successful CDISC Deliverables! Santosh Reddy Lekkala,
Bhavin Busa		 source
presentation source		 4
PHUSE US 2019 Have You Met Define-XML v2.0? Christine McNichol source
presentation source		 12
PHUSE US 2019 High-quality Study Data Standards for Submission Majdoub Haloui,
Ellen L. Asam		 source
presentation source		 9
PHUSE US 2019 Identifying Hurdles for Submission of Electronic Nonclinical Data (SEND) Bob Friedman,
Lou Ann Kramer		 source
presentation source		 10
PHUSE US 2019 Let's Create Standard Value-level Metadata David A. Fielding source
presentation source		 8
PHUSE US 2019 Using an MDR to Manage Your Lab Test Definitions Daniel Ringenbach,
Roopa Kandukuri		 source
presentation source		 7
PHUSE EU 2018 Automated Creation of Submission-Ready Artifacts [presentation] Silas McKee,
Lourdes Devenney		 source 15
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 Practical Lessons Learned from Recent NDA and BLA Submissions to the FDA Carey G. Smoak,
Lisa Brooks		 source
presentation source		 5
PHUSE EU 2018 Stop Copying CDISC Standards Craig Parry source
poster source		 21
PHUSE EU 2018 The "CDISC Stupidario" (the CDISC Nonsense) Angelo Pinazzi source
poster source		 11
PHUSE EU 2018 Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms Using a CDISC ODM API Samuel Hume,
Geoff Low		 source
presentation source		 12
WUSS 2018 CDISC in Phase I/II Studies: Approaches to adopting standards for CSR deliverables Emily Woolley,
Amber Randall		 source 9
PHUSE US 2018 Confusing Data Validation Rules Explained Michael Beers source
presentation source		 5
PHUSE US 2018 CRF Design for Data Standards David A. Scocca source
presentation source		 4
PHUSE US 2018 How do I have ONE Interpretation of CDISC for all my Studies? Mor Meyerovich source
presentation source		 5
PHUSE US 2018 Incorporating Pinnacle 21 with LSAF Sonali Garg,
Aleksey Vinokurov		 source
presentation source		 6
PHUSE US 2018 Keeping Control in a Changing World Johannes Ulander source
presentation source		 6
PHUSE US 2018 Optimizing SDTM Specification Development with Auto-population Cori Kramer,
Ryan Adalbert		 source
presentation source		 6
PHUSE US 2018 SDTM and SEND: An Integrated View and Approach Veena Nataraj,
Cheryl Riel		 source
presentation source		 11
PHUSE US 2018 Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms Using a CDISC ODM API Samuel Hume,
Geoff Low		 source
presentation source		 12
PharmaSUG 2018 Accessing the Metadata from Define-XML Lex Jansen source 44
PharmaSUG 2018 ADaM for Medical Devices: Extending the Current ADaM Structures Julia Yang,
Sandra Minjoe		 source 7
PharmaSUG 2018 Best Practices in Data Standards Governance Melissa R. Martinez source 4
PharmaSUG 2018 Confusing Data Validation Rules Explained Michael Beers source 6
PharmaSUG 2018 Diagnostics of technical errors in define.xml file Sergiy Sirichenko,
Max Kanevsky		 source 9
PharmaSUG 2018 Family of PARAM***: PARAM, PARAMCD, PARAMN, PARCATy(N), PARAMTYPE Kamleshkumar Patel source 12
PharmaSUG 2018 Improving Metadata Compliance and Assessing Quality Metrics with a Standards Library Veena Nataraj,
Erica Davis		 source 9
PharmaSUG 2018 Incorporating Pinnacle 21 with LSAF Aleksey Vinokurov,
Sandeep Juneja,
Sonali Garg		 source 6
PharmaSUG 2018 Integrations Made Easier Kirsty R. Lauderdale source 6
PharmaSUG 2018 It's all about getting the Source and Codelist Implementation right for ADaM Define.xml v2.0 Supriya Davuluri source 11
PharmaSUG 2018 Preparing to Meet FDA Requirements for Submission of Standardized Data and Documentation Steven R. Kirby,
Mario Widel		 source 11
PharmaSUG 2018 Stay ahead of the game: Know the SDTM compliance check reject messages before creating your SDTM datasets Lixiang Larry Liu,
Yuqin Li		 source 6
PharmaSUG 2018 Watch Out For Blind Spots While Keeping Up With the Speed of Evolving Standards and Regulations Srinivas Veeragoni source 14
PHUSE EU 2017 CDISC Transport Standards - A Glance Edwin Ponraj Thangarajan,
Giri Balasubramanian		 source
presentation source		 14
PHUSE EU 2017 Considerations and Conventions in the Submission of the SDTM Tumor and Response Domain Jerry Salyers,
Fred Wood		 source
presentation source		 7
PHUSE EU 2017 Constrain your Terminology - Use Integrity Constraints to Validate your Data Sven Greiner source
presentation source		 9
PHUSE EU 2017 Consuming Your Metadata for a Healthy Mapping Alan Cantrell,
Julius Kusserow		 source
presentation source		 4
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 SDTM vs CDASH: Why You Need Them Both! [presentation] Kit Howard,
Shannon Labout		 source 20
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
MWSUG 2017 Mapping MRI data to SDTM and ADaM Lingling Xie,
Xiaoqi Li		 10
PharmaSUG 2017 Ahead of the Curve: Leading with Industry Data Requirements Maria Dalton,
Nancy Haeusser		 source 17
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 CDISC Compliant NCA PK Parameter Analysis When Using Phoenix WinNonlin Renfang Hwang source 11
PharmaSUG 2017 Common Programming Errors in CDISC data Sergiy Sirichenko source 9
PharmaSUG 2017 Considerations and Conventions in the Submission of the SDTMIG Tumor and Response Domains Jerry Salyers,
Fred Wood		 source 7
PharmaSUG 2017 Controlled Terminology Without Excel Mike Molter source 15
PharmaSUG 2017 Deriving Rows in CDISC ADaM BDS Datasets Sandra Minjoe source 12
PharmaSUG 2017 Harmonizing CDISC Data Standards across Companies: A Practical Overview with Examples Keith Shusterman,
Prathima Surabhi,
Binoy Varghese		 source 6
PharmaSUG 2017 Laboratory Data Standardization with SAS Charley Z. Wu,
Dona-Lyn Wales		 source 12
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 SAS Application to Automate a Comprehensive Review of DEFINE and All of its Components Walter H. Hufford Jr.,
Vincent Guo,
Mijun Hu		 source 8
PharmaSUG 2017 Usage of Pinnacle 21 Community Toolset 2.x.x for Clinical Programmers Sergiy Sirichenko,
Michael DiGiantomasso		 source 23
SGF 2017 Deriving Rows in CDISC ADaM BDS Data Sets Using SAS DATA Step Programming Sandra Minjoe source 17
SESUG 2016 SDTM What? ADaM Who? A Programmer's Introduction to CDISC Venita DePuy source 9
PHUSE EU 2016 Fast Track to Define-XML v2.0 - SDTM and ADaM Jörn Bilow source
presentation source		 4
PHUSE EU 2016 How to Handle Different Versions of SDTM & Define Generation in a Single Day Edwin Ponraj Thangarajan,
Giri Balasubramanian		 source
presentation source		 22
PHUSE EU 2016 Pattern-based MDR: Towards High-quality Data Standards Alan Cantrell,
Julius Kusserow		 source
presentation source		 7
PHUSE EU 2016 To Create Define-XML Using - XML and the OpenCDISC Validator [presentation] Murali Neela source 17
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 CDISC Standards End-to-End: Transitional Hurdles Alyssa M. Wittle,
Christine McNichol,
Antonio Cardozo		 source 6
PharmaSUG 2016 Codelists Here, Versions There, Controlled Terminology Everywhere Shelley Dunn source 12
PharmaSUG 2016 Moving up! - SDTM v3.2 - What is new and how to use it Alyssa M. Wittle,
Christine McNichol,
Antonio Cardozo		 source 8
PharmaSUG 2016 New Features in Define-XML V2.0 and Its Impact on SDTM/ADaM Specifications Hang Pang source 12
PharmaSUG 2016 SDTM Trial Summary Domain: Putting Together the TS Puzzle Kristin Kelly,
Jerry Salyers,
Fred Wood		 source 13
PharmaSUG 2016 Submission-Ready Define.xml Files Using SAS Clinical Data Integration Melissa R. Martinez source 10
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
PHUSE EU 2015 Ensuring Data Quality in Outsourced Studies - The Role of the Data Scientist Sarah Malbon,
Vikki Horton		 source
presentation source		 8
PHUSE EU 2015 Errors Beyond Open CDISC Validator Gayatri Karkera,
Nehan Mohan		 source
presentation source		 4
PharmaSUG 2015 A SAS Macro Tool to Automate Generation of Define.xml V2.0 from ADaM Specification for FDA Submission Min Chen,
Xiangchen (Bob) Cui		 source 28
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 Summing up - SDTM Trial Summary Domain Yi Liu,
Jenny Erskine,
Stephen Read		 source 9
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 2015 What to Expect in SDTMIG v3.3 Fred Wood source 10
SESUG 2014 SDTM What? ADaM Who? A Programmer's Introduction to CDISC Venita DePuy source 9
PHUSE EU 2014 Automating Production of the blankcrf.pdf Walter H. Hufford Jr. source
presentation source		 5
PHUSE EU 2014 Every Study is Special! - Governing Data Standards Chris Price,
Elizabeth Nicol		 source
presentation source		 12
PHUSE EU 2014 Handling Non-Standardised Questionnaires Anne Sophie Beckx,
Éanna Kiely		 source
presentation source		 5
PHUSE EU 2014 Metadata, Study Standards, Interoperability: Key Concepts Toward Compliance to FDA Guidance Isabelle de Zegher source
presentation source		 3
PHUSE EU 2014 Representation of CDISC Foundational Standards Using RDF Authors Scott A. Bahlavooni,
Frederik Malfait		 source
presentation source		 3
PharmaSUG 2014 Automating Production of the blankcrf.pdf Walter H. Hufford Jr. source 5
PharmaSUG 2014 Challenges in Processing Clinical Lab Data Alan Meier source 15
PharmaSUG 2014 Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions Using SAS Karin LaPann,
Terek J. Peterson		 source 20
PharmaSUG 2014 Creating Define-XML version 2 with the SAS Clinical Standards Toolkit 1.6 Lex Jansen source 33
PharmaSUG 2014 Creating Define.xml v2 Using SAS for FDA Submissions Qinghua (Kathy) Chen,
James Lenihan		 source 20
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 XML in a SAS and Pharma World Mike Molter source 19
SGF 2014 Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions Using SAS Karin LaPann,
Terek J. Peterson		 source 19
SGF 2014 Creating Define.xml v2 Using SAS for FDA Submissions Qinghua (Kathy) Chen,
James Lenihan		 source 20
WUSS 2013 Implementation of DEFINE.XML Generators using SAS Hash Objects and User-Defined Functions Lei Zhang source 19
PHUSE EU 2013 A How-To Guide for Extending Controlled Terminology Using SAS Clinical Data Integration [presentation] Melissa R. Martinez source 71
PHUSE EU 2013 Check your Standards - An Example Véronique Bourcier source
presentation source		 6
PHUSE EU 2013 Considerations in the Submission of Holter (EG) Data in an SDTM Compliant Format Elsa Lozachmeur,
Sophie Arnould		 source
presentation source		 7
PHUSE EU 2013 Define-XML v2 - What's New Lex Jansen source
presentation source		 15
PHUSE EU 2013 SDTM Oncology Domains: From Patient to Data to Narrative Kennenth Stolzfus source
presentation source		 4
PHUSE EU 2013 Two-way Ticket, Please...All aboard the SAS Clinical Standards Toolkit 1.5 Express Lex Jansen source
presentation source		 2
PharmaSUG 2013 A Generic Concept to Handle SDTM (and other CDISC) Data Sets Peter Schaefer source 8
PharmaSUG 2013 Considerations in Data Modeling when Creating Supplemental Qualifiers Datasets in SDTM-Based Submissions Fred Wood source 12
PharmaSUG 2013 Considerations in the Use of Timing Variables in Submitting SDTM-Compliant Datasets Jerry Salyers,
Richard Lewis,
Fred Wood		 source 6
PharmaSUG 2013 Data Standards Will Be Required: Challenges for Medical Device Submissions Carey G. Smoak,
Kit Howard,
Fred Wood,
Rhonda Facile		 source 5
PharmaSUG 2013 Introduction to the CDISC Standards Sandra Minjoe source 10
PharmaSUG 2013 Programming Validation Tips prior to using OpenCDISC validator Dany Guerendo source 12
PharmaSUG 2013 SDTM Harmonization in the Absence of CDASH - A Modularized Approach to Domain Programming Annie S. Guo source 12
PharmaSUG 2013 Standardizing the Standards: A Road Map for Establishing, Implementing and Unifying Standards in Your Organization Amy Caison,
Jhelum Naik,
Tammy Jackson		 source 9
SGF 2013 A Practical Approach to Creating Define.XML by Using SDTM Specifications and Excel functions Amos Shu source
pdf		 7
PHUSE EU 2012 ADaM Or SDTM? A Comparision of Pooling Strategies for Integrated Analyses in the Age of CDISC Joerg Guettner,
Alexandru Cuza		 source
presentation source		 7
PHUSE EU 2012 Controlling Controlled Terminology Ryan Burns source
poster source		 5
PHUSE EU 2012 Define.xml for ADaM: From Results to SDTM [presentation] Dimitri Kutsenko source 5
PHUSE EU 2012 Mapping the Company's Legacy Data Model to SDTM Anja Feuerbacher,
Bruce Rogers		 source
presentation source		 7
PHUSE EU 2012 One Approach to a Metadata and Data Standards Repository Bill J. Gibson source
poster source		 4
PHUSE EU 2012 Simplifying SAS Clinical Standards Toolkit - Where's the Easy Button? Gene Lightfoot source
poster source		 6
PHUSE EU 2012 Validation to define.xml Sam Tomioka,
Steven Huang		 source
poster source		 8
SESUG 2012 An Introduction to the Clinical Standards Toolkit Mike Molter source 13
WUSS 2012 Developing Integrated Summary of Safety Database using CDISC Standards Rajkumar Sharma source 7
PharmaSUG 2012 An Innovative ADaM Programming Tool for FDA Submission Xiangchen (Bob) Cui,
Min Chen,
Tathabbai Pakalapati		 source 25
PharmaSUG 2012 An Introduction to the Clinical Standards Toolkit and Clinical Data Compliance Checking Mike Molter source 14
PharmaSUG 2012 Automatic Consistency Checking of Controlled Terminology and Value Level Metadata between ADaM Datasets and Define.xml for FDA Submission Xiangchen (Bob) Cui,
Min Chen		 source 15
PharmaSUG 2012 CDISC SDTM Conversion in ISS/ISE Studies: Tools Balaji Ayyappan source 6
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
PharmaSUG 2012 Creating an Integrated Summary of Safety Database using CDISC ADaM : Challenges, Tips and Things to Watch Out Rajkumar Sharma source 7
PharmaSUG 2012 Transform Incoming Lab Data into SDTM LB Domain with Confidence Anthony L. Feliu source 27
SGF 2012 Automatic Consistency Checking of Controlled Terminology and Value Level Metadata between ADaM Datasets and Define.xml for FDA Submission Xiangchen (Bob) Cui,
Min Chen		 source 15
SGF 2012 Defining the Development Process and Governance of Implementing ADaM within an Organization Chris Decker source 11
SESUG 2011 Resolving OpenCDISC Error Messages Using SAS John R. Gerlach source 11
PHUSE EU 2011 A SAS macro to check SDTM domains against controlled terminology Guido Wendland source
presentation source		 10
PHUSE EU 2011 Defining the Governance and Process of Implementing ADaM across an Organization Chris Decker source
presentation source		 11
PHUSE EU 2011 Remapping of Codes (and of course Decodes) in Analysis Data Sets for Electronic Submissions Joerg Guettner source
presentation source		 5
PHUSE EU 2011 SDTM Implementation Guide - Clear as Mud: Strategies for Developing Consistent Company Standards Brian Mabe source
presentation source		 5
NESUG 2011 Automating SDTM File Creation: Metadata Files Speeding the Process Daphne E. Ewing 7
NESUG 2011 Generating Define.xml Sandeep Kottam,
Uma Sarath Annapareddy,
Sree Lakshmi Kalyani Tripuraneni		 20
PharmaSUG 2011 A Cost-Effective SDTM Conversion for NDA Electronic Submission Xiangchen (Bob) Cui,
Scott E. Moseley,
Min Chen		 source 12
PharmaSUG 2011 Brave New World: How to Adapt to the CDISC Statistical Computing Environment Jeffrey M. Abolafia,
Frank C. DiIorio		 source 11
PharmaSUG 2011 CDISC Variable Mapping and Control Terminology Implementation Made Easy Balaji Ayyappan,
Manohar Sure		 source 5
PharmaSUG 2011 Ensuring Consistent Data Mapping Across SDTM-based Studies - a Data Warehouse Approach Annie S. Guo source 12
PharmaSUG 2011 Evolution of SDTMIG 3.1.1 to 3.1.2: A mapping specialist must reference on these changes Rachit Desai,
Anirudh Gautam,
Vikash Jain		 source 8
PharmaSUG 2011 Find / Track / Check and Close, Using SAS to Streamline SDTM Validation Including the Hyperlinks David Tillery,
Qiang Zhai,
Lily Peng		 source 5
PharmaSUG 2011 New Tips and Tricks for Creating a Harmonized, Report-Friendly SDTM and ADaM Lab Data for a Clinical Study Report Xiangchen (Bob) Cui,
Min Chen,
Scott E. Moseley		 source 12
PharmaSUG 2011 The Standard for the Exchange of Nonclinical Data (SEND): History and Basics Fred Wood,
Lou Ann Kramer		 source 9
PharmaSUG 2011 Trials and Tribulations of SDTM Trial Design Fred Wood,
Mary Lenzen		 source 5
PharmaSUG 2011 Truncation, Variable Association, Controlled Terminology, and Some Other Pitfalls in the SDTM Mapping Process Na Li,
Gary de Jesus,
Daniel Bonzo		 source 8
PharmaSUG 2011 Validating Controlled Terminology in SDTM Domains John R. Gerlach source 12
NESUG 2010 Automating SDTM File Creation: Metadata Files Speeding the Process Daphne E. Ewing 7
PHUSE EU 2010 Accessing the metadata from the define.xml using XSLT transformations Lex Jansen source
presentation source		 24
PHUSE EU 2010 CDISC integration in a clinical data management system Peter Van Reusel source
presentation source		 13
PHUSE EU 2010 From ACE to ZINC Paul Vervuren source 8
PharmaSUG 2010 Accessing the metadata from the define.xml using XSLT transformations Lex Jansen 24
PharmaSUG 2010 Checking for SDTM Compliance: The Need for Human Involvement Fred Wood,
Adrienne Boyance		 8
PharmaSUG 2010 In-Depth Review of Validation Tools to Check Compliance of CDISC SDTM-Ready Clinical Datasets Bhavin Busa,
Kimberly Lindfield		 52
PharmaSUG 2010 Quality in a World of "Standards" with Differences! Sandra VanPelt Nguyen 9
PharmaSUG 2010 The CDISC/FDA Integrated Data Pilot: A Final Summary of Findings, Reviewer Feedback, and Recommendations Implementing CDISC Standards Within and Across Studies Chris Decker 20
SGF 2010 Automating SDTM File Creation: Speeding Up the Process with Metadata Files Daphne E. Ewing source 7
SESUG 2009 A SAS Macro to Automate the Process of Define.xml Wenyu Hu,
Liping Zhang		 source 5
PHUSE EU 2009 Experiences and lessons learned from a first SDTM submission project Paul Vervuren,
Bas van Bakel		 source
presentation source		 12
PHUSE EU 2009 Generate Define.xml & Define.pdf from Metadata Environment Rohit Banga source
presentation source		 11
PHUSE EU 2009 SDTM Validation: How can we do it right? Peter Van Reusel source
presentation source		 8
PHUSE EU 2009 The CDISC/FDA Integrated Data Pilot: A Case Study in Implementing CDISC Standards to support an Integrated Review Chris Decker source
presentation source		 15
NESUG 2009 Supporting CDISC Standards in Base SAS Using the SAS Clinical Standards Toolkit Peter Villiers 13
PharmaSUG 2009 Supporting CDISC Standards in Base SAS Using the SAS Clinical Standards Toolkit Supporting CDISC Standards 13
PharmaSUG 2009 Using CDISC Lab Terminology and Determining Standard Units Matthew Davis 7
SGF 2009 A SAS Programmer's Guide to Generating Define.xml Michael J. Molter source 24
SGF 2009 Supporting CDISC Standards in Base SAS Using the SAS Clinical Standards Toolkit Peter Villiers source 13
PHUSE EU 2008 Implementing CDISC at Boehringer Ingelheim Michael Knoessl,
Peter Leister		 source 5
PharmaSUG 2008 A SAS based solution for define.xml Monika Kawohl 18
PharmaSUG 2008 A Toolkit for CDISC Implementation Robert T. Stemplinger 6
PharmaSUG 2008 Case Study: Analysis and Metrics of End-to-End Legacy Data Conversions into SDTM, ADaM, and Define.xml Robert T. Stemplinger 5
PharmaSUG 2008 Cost-Effective Solution to Automating the Creation of CDISC define.xml: Using SAS Data _Null_ with Relational Data Model via SAS/AF Application Annie S. Guo 12
PharmaSUG 2008 Experiences Submitting CDISC SDTM and Janus Compliant Datasets Carol Vaughn,
Gregory Ridge,
William Friggle		 10
PharmaSUG 2008 Mission Possible: A Proposed SDTM Domain for the Medical Device and Diagnostic Industry Carey G. Smoak 2
PharmaSUG 2008 SAS, CDISC and Clinical Data Integration Peter Villiers 27
PharmaSUG 2008 Validating CDISC SDTM-Compliant Submission-Ready Clinical Datasets with an In-House SAS Macro-Based Solution Bhavin Busa,
Sheila Vince,
Jameelah Aziz		 12
SGF 2008 Practical Methods for Creating CDISC SDTM Data Sets from Existing Data Robert W. Graebner source 11
SGF 2008 The Evolution of SAS in Life Sciences Research and Development David Handelsman source 10
PHUSE EU 2007 A SAS based solution for define.xml Monika Kawohl source 18
PharmaSUG 2007 Best Practices for Working with CDISC Metadata in the SAS Data Integration Server Michael Kilhullen 10
PharmaSUG 2007 Implementing CDISC Data Models in the SAS Metadata Server Michael Kilhullen 7
PharmaSUG 2007 Strategies and Practical Considerations for Creating CDISC SDTM Domain Data Sets from Existing CDM Data Sets Robert W. Graebner 12
PharmaSUG 2006 Implementing CDISC Data Models in the SAS Metadata Server Michael Kilhullen 7
PHUSE EU 2005 SAS Dataset Content Conversion to CDISC Data Standards Anthony L. Friebel source 9
PharmaSUG 2005 SAS Dataset Content Conversion to CDISC Data Standards Anthony L. Friebel,
Thomas Cox,
Edward D. Helton		 10

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