Opening Session - Dong Guo & Steven Shi

Keynote 1: FDA Study Data Technical Rejection Update (Heather Crandall)

Keynote 2: Moving at the Speed of Science: Lessons Learned in Response to the Covid-19 Pandemic (Patti Compton/Henry Shen)

Morning break

Special presentation 1: Data FAIRification: a foundation for accelerating insight generation (Shuang Li/Li Han of Roche)

Special presentation 2: A Brief Introduction to Natural Language Processing in Healthcare (Xiaohua Li of Zuoyi Tech)

AD-03: Data De-identification of Demographic Detail in Adult and Pediatric Study (Huan Lu)

AD-08: Risk of Re-identification Assessment (Lanlan Peng)

AD-14: Development of Integrated Statistical Computing Platform (iSCP) Based on Intelligent Apps (Zhiping Yan)

AD-44: ISPP, an Integrated Statistical Programming Platform to systematically manage study programing environment, program, output, log, lst and more. (Jinling Li)

AD-80: Right Tool for Right Analysis - Optimize Statistical Programming Deliverables Leveraging Multiple Analytical Tools (Chun Yi)

AD-35: CRF Chinese Translation – Mask Plan (Chunpeng Zhao, Liming Xie and Chunling Xu)

Afternoon break

AD-101: Multi-study programming – a best practice outline (Matthew Metherell and Simon Purkess)

AD-67: SDTM ARTs: a CRF-Driven SDTM Automation Tool for Generating aCRF, SDTM Mapping Specification and Programs (Haiqiang Luo, Kaiying Li, Xiaoyi Niu and Xiaoxia Zhou)

AD-11: Auto-annotation in SDTM aCRF Using R Package and SAS (Teresa Tang)

AD-13: A tool to combine TFL outputs (Jason Wang and Yashan Zhou)

DS-06: NMPA Data submission requirements and Conformance Check (Victor Wu and Xue Hu)

DS-36: SDTM Annotated CRF Digitalization (Chunpeng Zhao, Mijun Hu, Jiapeng He and Aide Zhou)

DS-07: A Customizable Conformance Check Tool Design (Haiping Yu and Dan Li)

DS-09: SAS Macro Solution for NMPA Submission Data Validation Rules (Ting Sun and Jipian He)

DS-42: Essential project management skill for solving potential risks of electronic study data submission to PMDA (Manabu Uehara and Takashi Kitahara)

DS-100: Introduction to Handling Efficacy Data in CDISC Standard Datasets (Kate Booth)

Afternoon break

DS-47: Challenges and solutions for e-data submission to NMPA under new regulation (Grace Sun)

DS-82: New Tools for aCRF Translation in NMPA Database Preparation (Qingyu Wang and Stanley Wei)

DS-102: A case of mistaken ID: reimagining rescreenings and reenrollments (Matthew Metherell)

DS-83: How to show the specific treatment nicely in the SDTM? (Manxi Chen)

CC-85: Dataset Deor: Tips for You to Explore its Mystery in SAS (Yu Cheng)

CC-53: A SAS Macro to Generate Customized Patient Profile Output Simply (Mingyue Zhu)

CC-73: Float-point number and encode in SAS (Weineng Zhou)

CC-81: The Hidden Influence of Program Structure in SAS DATA step (Xiangyu Song)

CC-15: How to Translate RTF Documents (Jundong Ma and Zhiping Yan)

CC-37: Automated Solution to Make an RTF Table Continuous (Danfeng Fu, Qian Wang and Hui Liu)

Afternoon break

CC-76: Estimating Binomial Proportion Confidence Interval with Zero Frequency Response using FREQ Procedure (Linga Reddy Baddam)

CC-04: TFLs Title Check Tool (Beixin Lu)

CC-50: DoseAnalysisUsingConcomitant/Prior Medications(CM) Domain (Wenjun Hu)

CC-59: The Brief Introduction of UTF-8 in SAS (Zijun Li and Xiaodong Shi)

SR-79: Interactive web widgets and applications in R (Changming Yang)

SR-34: A practical simulation-based method to assess operating characteristics of adaptive design for clinical trial with time-to-event endpoints: A case study in an adaptive population enrichment design with multiple endpoints and sample size re-estimation. (Yang Ding, Chunyan He, Daijing Yuan and Xin Zhang)

SR-38: A novel insight into confirmed Best Overall Response per RECIST 1.1 (Shuangbin Ji)

SR-41: Number of Events Estimation using R step by step (Chunyan He and Liyan Zhao)

SR-52: Sing Old Song in A New Tone: RECIST 1.1 (Han Wang and Jiaqi Wang)

SR-55: Statistical considerations in a case study disrupted by COVID-19 pandemic (Kun Li)

Afternoon break

SR-62: Tips and Tricks: A real case of MI (Multiple Imputation) implementation in SAS (Xianjun Li)

SR-57: BIP: A Powerful Biomarker Interactive Profiler based on R Shiny APP (Miao Yu and Chun Yi)

SR-66: Block Randomization Allocation Tool(BRAT) — An R Shiny App to Support Pre-Clinical Process Automation (Shuo Zhang and Chun Yi)

SR-78: The Application of Reference-Scaled Average Bioequivalence in Bioequivalence Analysis with Highly Variable Drug (Chuying Dai)

AD-72: Using R Shiny to Explore Clinical Trial Data (Yaoxian Yuan and Jiaying Wu)

AD-40: Automation for CRF Annotation and Bookmark Generation via Python (Peng Wang and Yiqun Wang)

AD-49: An approach to generate define.xml for submission in China based on Python (Siyi Li)

AD-61: Leveraging Python Streamlit to do project management (Zhiwei Luo)

Morning break

AD-20: Title/footnote Auto Extraction from TLG shell to Program Tracker (Jiapeng He and Tingting Zeng)

AD-32: A Submission Package Translation Toolkit by SAS and Excel VBA (Shijia Wang)

AD-45: Automating SAS EG Integration technologies via Excel VBA (Xiaoyang Yu)

AD-75: Automated Process from aCRF to ADRG for SAS programming with Python and VBA (Weineng Zhou)

DV-05: Review Response Data with an R Shiny App (Hengwei Liu and Fuyuan Pang)

DV-77: Interactive Visual Analysis on Large Screen for Clinical Trials (Gaoyang Li, xiang wang and Xiao Wang)

DV-22: SAS Macro to Derive Integrated PET+CT Response in FDG-avid Lymphoma per Lugano 2014 (Jia Xu, Wenxiao Zhou, Xiaotong Li and Ziwen Tan)

DV-30: Visualization to detect risks of clinical data in Risk-Based Quality Management (Raymone Xu)

Morning break

DV-39: Utilizing Plotly in R to Review Clinical Data with Interactive Plots (Kailu Song)

DV-103: Employing TIBCO Spotfire for clinical data review (Hao Huang)

DV-68: Visualization of Oncology data from Interactive Dashboards (Jie Yue)

DV-21: Modular Programming for Data Visualization (Yuzheng Ou)

MA-70: New Opportunities and Challenges for Statistical Programming Job Position in China Bio-Pharma (Yu Cheng and Xin Wang)

MA-88: Statistical Programming – An Evolving Role (Cindy Song)

Morning break

MA-71: Using Strengths to Advance Your Career Development (Wei Diao)

MA-48: Be a digital pioneer — How to develop your career? (Gaoyang Li and Jian Shen)

DM-93: Risk Based Data Management and the Implementation (Xiaodan Qi)

DM-19: One-stop solution using Spotfire for Data Validation (Jiaming Chen)

DM-89: A Live Data Validation Adjustment- Edit Check Optimization (ECO) Initiative in multiple application scenarios (Yi Ji)

DM-92: Target SDV Overview (Yaxi Wang)

Morning break

DM-18: Don’t Panic: A Data Manager’s Guide to SDTM (Lanjin Jin)

DM-94: Get eCRF built fast by using company MDR (Yijie Gu)

DM-16: Quality Management of Critical Data from eDevice in Decentralized Clinical Trial (Yueqing Yvonne Wang and Binqi Ye)

DM-69: Application of JMP Clinical to Oncology Trial Medical Monitoring During COVID-19 (Xiao Huang and Liguo Cheng)

AD-58: Tips for Learning Python and Application in Statistical Programming Daily Work (Wei (Tony) Zhang)

DS-46: Annotated CRF Submission to NMPA for Foreign Database (Shan Wan)

DS-51: Coding Data Translation Process (Chunling Xu)

DS-33: Consideration and Solutions of Garbled Codes in Multiple Languages Projects (Yi Lu and Shijia Wang)

CC-26: Surviving Left Truncation: Number at Risk Calculation for a Specific Timepoint Using SAS (Rolland LUO and Lihua Wu)

CC-65: Customize EXCEL Output (Hui Liu)

DM-10: Easy Clinical Data Monitoring and Case Presentation (Joice Hu and Jialei Zhang)

DM-23: Implementation of Data Cut-Off in Analysis of Oncology Clinical Trials (Shang Shi, Weibin Cai and Zhiping Yan)

DM-28: Raw Data Issue Check Using Call Execute (Lihua Wu and Goldie Guo)

Special Presentation 3: Unveiling Estimand-Estimand X Data Scientist (Leslie Meng of Boehringer-Ingelheim)

Panel Discussion: Opportunities and challenges of statistical programming - Post Pandemics

Closing session - PharmaSUG China 2022