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safety population

43 papers and 19 presentations; 58 titles.

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Conference × Year × Title × Authors Extras Pages
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 One Pipeline, Zero First Drafts: A Metadata-and-LLM Toolkit for Automated TFL Program Generation Hefan Jing,
Peilin Liu		 source 10
PharmaSUG 2026 Early-Careers Essentials: Practical Checklists for Manual TLF Review Ingrid Shu,
Xinhui Zhang		 source 7
PharmaSUG 2026 Programming Challenges in Developing PRO Analysis Datasets Under FDA's New Submission Guidance Weiwei Guo,
Caizhi Huang		 source 10
PHUSE US 2026 Common Issues in BIMO Clinical Site Dataset Packages Michael Beers source
presentation source		 7
PHUSE EU 2025 AI Chatbot in an SCE Shivoy Pandita,
Marc Jantke		 source
presentation source		 8
PHUSE EU 2025 gridify: Enrich Figures and Tables with Custom Headers and Footers Maciej Nasinski,
Alexandra Wall		 source
poster source		 10
MWSUG 2025 More Muggles, More Macros: Adding Advanced Data-Driven Wizardry to Your SAS Programs [presentation] Joshua M. Horstman,
Richann J. Watson		 source 45
SESUG 2025 More Muggles, More Macros: Adding Advanced Data-Driven Wizardry to Your SAS Programs Joshua M. Horstman,
Richann J. Watson		 45
WUSS 2025 More Muggles, More Macros: Adding Advanced Data-Driven Wizardry to Your SAS Programs [presentation] Joshua M. Horstman,
Richann J. Watson		 source 45
PharmaSUG 2025 ADaM and TFLs for Drug-induced Liver Injury (DILI) Analysis Song Liu,
Rambabu Sura		 source 7
PharmaSUG 2025 Common Issues in BIMO Clinical Site Dataset Packages Michael Beers source 9
PHUSE US 2025 Selecting GeARS: Analysis Results Standard Implementation Options for Accelerated Analysis and TFL Automation Bhavin Busa,
Richard Marshall		 source
presentation source		 10
PHUSE EU 2024 Anatomy of a Table - Our Continued Journey to Automating Output Delivery Through Metadata Edwin van Stein source
poster source		 10
PHUSE EU 2024 Auto-Generating the List of Tables from a Statistical Analysis Plan - A Case Study [presentation] Jaya Simha Inampudi,
Krishna Gopal		 source 14
PharmaSUG CN 2024 Application of I&I Late Phase in Programming Renxiang Wang source 15
PharmaSUG 2024 Demystifying Incidence Rates: A Step-by-Step Guide to Adverse Event Analysis for Novice Programmers Yuting Peng,
Ruohan Wang		 source 10
PharmaSUG 2024 Integrity, Please: Three Techniques for One-Step Solution in Pharmaceutical Programming Jason J. Su source 15
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 Ups, Downs, and FDA Crowns - Lessons Learned from BIMO Submission Adventures! [presentation] Sushant Thakare source 21
PHUSE EU 2023 Design Considerations for Building a System for Automated Statistical Analysis Nicolai Skov Johnsen,
Christian Olsen		 source
presentation source		 6
WUSS 2023 Generation of AE (Adverse Events) summary tables by worst CTC Grade utilizing SAS Ballari Sen source 14
PharmaSUG 2023 BIMO Package: Challenges and Perspectives while keeping up with the upgrades in the BIMO Technical Conformance Guide and the BDRG Guidelines Mathura P. Ramanathan,
Sowmya Gabbula		 source 18
PharmaSUG 2023 Introducing TFL Designer: Community Solution to Automate Development of Mock-up Shells and Analysis Results Metadata [presentation] Bhavin Busa,
Navin Dedhia		 source 13
PharmaSUG 2023 Macro To Automate Crossover Review In Produced Outputs Igor Goldfarb,
Ella Zelichonok		 source 25
PHUSE US 2023 A Standard Data Set Format for the Validation of Tables and Listings in Regulatory Submissions for Clinical Trials Kevin R. Viel source
poster source		 10
PHUSE US 2023 Connecting Tables, Listings and Figures [presentation] Stella Guo source
video		 11
PHUSE US 2023 How Python or R Support/Facilitate the Validation Process of TFLs for a Study Development Using Hybrid SAS and R [presentation] Linshan Yuan,
Weiwei Xu		 source 19
PHUSE EU 2022 Best Practices for Automated Delivery Set-up, from Raw Data to CRT, with Methods to Standardise and Streamline Programming and Delivery Processes [presentation] Daniel Carden source
video		 21
PHUSE EU 2022 DataSet-JSON - Smaller than XML, But Just as Powerful [presentation] Fabian Noelle source 10
PHUSE EU 2022 My Journey from SAS to R [presentation] Lucy Watson source 15
PharmaSUG 2022 Avoid Common Mistakes in Preparing the BIMO Deliverables Chintan Pandya,
Himanshu Patel		 source 9
PharmaSUG 2022 From the Laboratory Toxicity Data Standardization to CTCAE Implementation Xiaoyin Zhong,
Jerry Xu		 source 7
PHUSE US 2022 'Verify Outputs' Product Demonstration: Validation of Statistical Outputs Using Automation [presentation] Ilan Carmeli,
Yoran Bar		 source
video		 17
PHUSE US 2022 DPS Helper: A Web Application to Create the Data Presentation Specifications Word Document in Clinical Trials [presentation] Asavari Mehta,
Xiaoguang Yan		 source
video		 37
PHUSE US 2022 Mesa: A Shiny-based Web Application for Drag-and-drop Creation of Metadata-driven Statistical Summary Tables [presentation] Qiaobing Bergsma,
Tim Bergsma		 source
video		 4
PHUSE US 2022 Table Mining: The Barrier for Automation [presentation] Ilan Carmeli,
Mor Ram-On		 source 16
PHUSE US 2022 The Emerging Use of Automation to Address the Challenge of Cross-Table Consistency Checking of Output Used in the Reporting of Clinical Trial Data [presentation] Hugh Donovan,
Naama Feilchenfeld		 source
video		 16
PHUSE EU 2021 CDISC Analysis Results Standard Team: Enhancing Analysis Results and Traceability [presentation] Bess LeRoy,
Jeffrey M. Abolafia		 source
video		 41
PHUSE EU 2021 Using R - TFL Generation with Custom Functions [poster] Jem Chang,
Vikram Kasarala		 source
video		 1
PHUSE US 2021 Software Demonstration: SD14: Accelerate your Transition to R in 4 months: Learn About the Accel2R Accelerated Learning Program [presentation] Steve Walker source 22
PharmaSUG 2021 Macro to Compare Titles and Footnotes in Produced TLF and Corresponding Shells Igor Goldfarb,
Ella Zelichonok		 source 26
SESUG 2020 Analysis and Reporting of Reactogenicity Events in Vaccine Clinical Trials Amarnath Vijayarangan,
Sarah G. Anderson,
Santhiya Poongavanam		 source 9
PharmaSUG 2020 Macro To Produce Sas-Readable Table Of Content From Tlf Shells Igor Goldfarb,
Ella Zelichonok		 source 18
PharmaSUG 2019 Joining the SDTM and the SUPPxx Datasets David W. Franklin source 9
PharmaSUG 2019 More Traceability: Clarity in ADaM Metadata and Beyond Wayne Zhong,
Richann J. Watson,
Daphne E. Ewing,
Jasmine Zhang		 source 26
PHUSE US 2018 Programmers are from Mars and Statisticians are from Venus Shweta Padmanaban,
Sangeetha Sathaiah		 source
presentation source		 6
PHUSE US 2018 Using the TFL Workbench for Standards Governance Hansjörg Frenzel,
Iain Humphreys		 source 9
PHUSE EU 2017 Check Your Code! Control Your Data! Kristina Zweier source
presentation source		 16
PHUSE EU 2014 Unuttered Questions of Statistical Programmers Aparajita Dey source
presentation source		 10
SESUG 2012 Diverse Report Generation With PROC REPORT Diverse Report Generation source 6
PharmaSUG 2012 Diverse Report Generation With PROC REPORT Chris Speck source 6
PharmaSUG 2009 %ANYTL: A Versatile Table/Listing Macro Yang Chen 11
PharmaSUG 2009 Automate the Process of Creating and Updating Titles and Footnotes of TLG for a Clinical Study Report from a Table Shell Document Xiangchen (Bob) Cui,
Shan Chen,
Mei Wu		 18
WUSS 2008 Seven Steps to Regulatory Publication Style with PROC REPORT Dennis Gianneschi source 6
PharmaSUG 2008 Automate Compiling Clinical Appendix Tables and Listings into a Review Package with a Hyper-Linked Table of Contents Xiangchen (Bob) Cui,
Wei Zhang		 20
PharmaSUG 2008 EZTABLE Macros Daniel Huang 12
PharmaSUG 2007 A Scalable Platform For Clinical Trials - Interoperability And Automation In A Web-Based Environment John R. Gerlach,
Maulik Shah		 11
PharmaSUG 2007 Three-Step Table Validation Yang Chen 7
SGF 2007 Seven Steps to Regulatory Publication Style with PROC REPORT Dennis Gianneschi source 6
PHUSE EU 2006 GKNIT your own - Creative ways to use Unix text tools for everyday problems David J. Garbutt source 17
PHUSE EU 2006 Standardization in Clinical Development Marianne Carames source 7

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