HOME QUICK SEARCH AUTHORS KEYWORDS HELP BUGS

Xiangchen (Bob) Cui

30 papers and 1 presentation; 29 titles; 16 coauthors.

Back to authors

Conference × Year × Title × Co-authors Extras Pages
PharmaSUG 2024 A New Approach to Automating the Creation of the Subject Visits (SV) Domain Jessie Wang,
Min Chen		 source 24
PharmaSUG 2024 A Practical Approach to Automating SDTM Using a Metadata-Driven Method That Leverages CRF Specifications and SDTM Standards Min Chen,
Jessie Wang		 source 23
PHUSE US 2024 A Practical Approach to Automating SDTM Using a Metadata-Driven Method that Leverages eCRF Specifications and SDTM Programming Standards Min Chen source
presentation source		 12
PharmaSUG 2023 Leverage and Enhance CDISC TAUGs to Build More Traceability for and Streamline Development of Efficacy ADaM in Oncology Studies source 29
PharmaSUG 2020 Simplifying the Derivation of Best Overall Response per RECIST 1.1 and iRECIST in Solid Tumor Clinical Studies Sri Pavan Vemuri source 24
PharmaSUG 2019 An Innovative Efficacy Table Programming to Automate Its Figure Generation to Ensure Both High Quality and Efficiency Letan (Cleo) Lin source 23
PharmaSUG 2019 Automate the Process to Ensure the Compliance with FDA Business Rules in SDTM Programming for FDA Submission Hao Guan,
Min Chen,
Letan (Cleo) Lin		 source 16
PharmaSUG 2019 Experiences in Building CDISC Compliant ADaM Dataset to Support Multiple Imputation Analysis for Clinical Trials source 20
PharmaSUG 2017 Leveraging Study Data Reviewer-s Guide (SDRG) in Building FDA-s Confidence in Sponsor-s Submitted Datasets Min Chen,
Letan (Cleo) Lin		 source 10
PharmaSUG 2016 A Practical Approach to Re-sizing Character Variable Lengths for FDA Submission Datasets (both SDTM and ADaM) Min Chen source 19
PharmaSUG 2016 A SAS Macro Tool to Automate Generation of Define.xml V2.0 from SDTM Specification for FDA Submission Min Chen 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 source 13
PharmaSUG 2015 A Methodology of Laboratory Data Reporting of Potentially Clinical Significant Abnormality (PCSA) for Clinical Study Report Min Chen source 21
PharmaSUG 2015 A SAS Macro Tool to Automate Generation of Define.xml V2.0 from ADaM Specification for FDA Submission Min Chen source 28
PharmaSUG 2014 Risk-Based Approach to Identifying and Selecting Clinical Sites for Sponsor's Preparation for FDA/EMA Inspection source 21
PharmaSUG 2013 Building Traceability for End Points in Analysis Data Sets Using SRCDOM, SRCVAR, and SRCSEQ Triplet Tathabbai Pakalapati,
Qunming Dong		 source 12
PharmaSUG 2013 Experiences in Preparing Summary Level Clinical Site Data within NDA's Submission for FDA's Inspection Planning source 19
SGF 2013 A Preventive Approach for Automatic Checking of CDISC ADaM Metadata to Detect Noncompliance [presentation] Min Chen,
Tathabbai Pakalapati		 source 2
SGF 2013 Building Traceability for End Points in Analysis Data Sets Using SRCDOM, SRCVAR, and SRCSEQ Triplet Qunming Dong,
Tathabbai Pakalapati		 source
pdf		 12
SGF 2013 Easy Button: A Process for Generating Standardized Safety- and Non-Safety- Related Clinical Trial Reports Jiannan Hu,
Mominul Islam,
Sanjiv Ramalingam,
Yanwei Han		 source 14
PharmaSUG 2012 An Innovative ADaM Programming Tool for FDA Submission Min Chen,
Tathabbai Pakalapati		 source 25
PharmaSUG 2012 Automatic Consistency Checking of Controlled Terminology and Value Level Metadata between ADaM Datasets and Define.xml for FDA Submission Min Chen source 15
PharmaSUG 2012 Automatic Detection and Identification of Variables with All Missing Values in SDTM/ADaM Datasets for FDA Submission Min Chen source 7
PharmaSUG 2012 Automatic Version Control and Track Changes of CDISC ADaM Specifications for FDA Submission Min Chen source 8
SGF 2012 Automatic Consistency Checking of Controlled Terminology and Value Level Metadata between ADaM Datasets and Define.xml for FDA Submission Min Chen source 15
SGF 2012 Examples of Building Traceability in CDISC ADaM Datasets for FDA Submission Hongyu Liu,
Tathabbai Pakalapati		 source 14
PharmaSUG 2011 A Cost-Effective SDTM Conversion for NDA Electronic Submission Scott E. Moseley,
Min Chen		 source 12
PharmaSUG 2011 Automating the Process of Preparing Data Definition Document for NDA Electronic Submission from Programming Specification in Word Format Min Chen,
Scott E. Moseley		 source 12
PharmaSUG 2011 New Tips and Tricks for Creating a Harmonized, Report-Friendly SDTM and ADaM Lab Data for a Clinical Study Report Min Chen,
Scott E. Moseley		 source 12
PharmaSUG 2009 Automate the Process of Creating and Updating Titles and Footnotes of TLG for a Clinical Study Report from a Table Shell Document Shan Chen,
Mei Wu		 18
PharmaSUG 2008 Automate Compiling Clinical Appendix Tables and Listings into a Review Package with a Hyper-Linked Table of Contents Wei Zhang 20

Back to authors