A Practical Approach to Automating SDTM Using a Metadata-Driven Method that Leverages eCRF Specifications and SDTM Programming Standards
Source category: Scripts, Macros & Automation
Author collections: Xiangchen (Bob) Cui · Min Chen
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Xiangchen (Bob) Cui — Indexed Papers
Publications credited to Xiangchen (Bob) Cui in the available conference metadata. Browse coauthors and original source links below. This is a publication index, not a verified biographical profile; identical names may refer to different people.
12 papers · Showing 1–12
Simplifying the Derivation of Best Overall Response per RECIST 1.1 and iRECIST in Solid Tumor Clinical Studies
Source category: Data Visualization and Reporting
Author collections: Xiangchen (Bob) Cui · Sri Pavan Vemuri
An Innovative Efficacy Table Programming to Automate Its Figure Generation to Ensure Both High Quality and Efficiency
Source category: Reporting and Data Visualizations
Author collections: Xiangchen (Bob) Cui · Letan (Cleo) Lin
Automate the Process to Ensure the Compliance with FDA Business Rules in SDTM Programming for FDA Submission
Source category: Applications Development
Author collections: Xiangchen (Bob) Cui · Min Chen · Letan (Cleo) Lin
Experiences in Building CDISC Compliant ADaM Dataset to Support Multiple Imputation Analysis for Clinical Trials
Source category: Statistics and Analytics
Author collections: Xiangchen (Bob) Cui
Leveraging Study Data Reviewer’s Guide (SDRG) in Building FDA’s Confidence in Sponsor’s Submitted Datasets
Source category: Submission Standards
Author collections: Xiangchen (Bob) Cui · Min Chen · Letan (Cleo) Lin
A Practical Approach to Re-sizing Character Variable Lengths for FDA Submission Datasets (both SDTM and ADaM)
Source category: Submission Standards
Author collections: Xiangchen (Bob) Cui · Min Chen
A SAS® Macro Tool to Automate Generation of Define.xml V2.0 from SDTM Specification for FDA Submission
Source category: Submission Standards
Author collections: Min Chen · Xiangchen (Bob) Cui
Automatic Consistency Checking of Controlled Terminology among SDTM Datasets, Define.xml, and NCI/CDISC Controlled Terminology for FDA Submission
Source category: Posters
Author collections: Min Chen · Xiangchen (Bob) Cui
A Methodology of Laboratory Data Reporting of Potentially Clinical Significant Abnormality (PCSA) for Clinical Study Report
Source category: Beyond the Basics
Author collections: Xiangchen (Bob) Cui · Min Chen
A SAS® Macro Tool to Automate Generation of Define.xml V2.0 from ADaM Specification for FDA Submission
Source category: Applications Development
Author collections: Min Chen · Xiangchen (Bob) Cui
Risk-Based Approach to Identifying and Selecting Clinical Sites for Sponsor’s Preparation for FDA/EMA Inspection
Source category: Beyond the Basics
Author collections: Xiangchen (Bob) Cui