PharmaSUG · 2026Paper SS-268PharmaSUG 2026Post-DBL Programming Update Tracker: Automating Revision Capture to Strengthen Audit Readiness, Oversight, and Compliance Across Programs and ADaM SpecificationsYunyi Jiang; Christine TengSource category: Submission Standards for Global Health AuthoritiesPaperADaMCDISCRegulatory SubmissionsAuthor collections: Yunyi Jiang · Christine TengRelated papersFrom Document to Derivation: Automating ADaM Variable and Endpoint Code Generation Using Study Specifications and Clinical Documents (2026)Managing a Single Set of SDTM and ADaM Specifications across All Your Phase 1 Trials (2024)A Tool for Automated Comparison of Core Variables Across ADaM Specifications Files (2024)
PharmaSUG · 2025Paper SS-135PharmaSUG 2025Evaluation of the Process to Create CLINSITE define.xml: Macro Approach vs. ADCLIN SpecYizhuo Zhong; Yunyi Jiang; Christine TengSource category: Submission StandardsPaperCDISCSAS Macro LanguageDefine-XMLRegulatory SubmissionsAuthor collections: Yizhuo Zhong · Yunyi Jiang · Christine TengRelated papersUsing One Specification to Create BIMO clinsite.xpt and its Define-XML (2023)SA01 Development of the Standard BIMO Process to Create the Clinsite Dataset (2019)An Alternative Way to Create Define.XML for ADaM with SAS Macro Automation (2014)
