PharmaSUG2025paper·China·Coder's Corner (CC)Development of an Automated Tool for Define.xml Generation and Review in Clinical Data Standardization CC-190 ShanghaiSee metadata
PharmaSUG2025paper·US·Data StandardsWhich ADaM Data Structure Is Most Appropriate? Gray Areas in BDS and OCCDS. DS-065See metadata
PharmaSUG2025paper·US·Data StandardsMultiple Imputation Techniques in the Context of ADaM Datasets DS-067See metadata
PharmaSUG2025paper·US·Data StandardsControlling attributes of .xpt files generated by R DS-075See metadata
PharmaSUG2025paper·US·Data StandardsBDS Dataset with PARQUAL and PARQTYP Variables for Time-to-Safety Events Analysis DS-079See metadata
PharmaSUG2025paper·US·Data StandardsTime-to-Deterioration for Patients Reported Outcomes DS-103See metadata
PharmaSUG2025paper·US·Data StandardsADaM Pet Peeves: Things Programmers Do That Make Us Crazy DS-105See metadata
PharmaSUG2025paper·US·Data StandardsImpact of Drug Accountability on Drug Compliance and Dose Intensity in Clinical Trials DS-109See metadata
PharmaSUG2025paper·US·Data StandardsDecoding Laboratory Toxicity Grading: Unlocking the Potential and Overcoming Challenges of CTCAE DS-123See metadata
PharmaSUG2025paper·US·Data StandardsADaM Fundamental Principles vs. Rules: Which to Follow, When, and Why? DS-126See metadata
PharmaSUG2025paper·US·Data StandardsA discussion of the new ADaM guidance (ADNCA and ADPPK) for pharmacokinetics. DS-169See metadata
PharmaSUG2025paper·US·Data StandardsWhat comes first, the chicken (ADSL) or the egg (ADNCA)? Modularize your covariate creation to support flexible analysis dataset implementation! DS-256See metadata
PharmaSUG2025paper·US·Data StandardsCytokine Release Syndrome (CRS) – Data Collection, Clinical Database Integration and Analyses in a Dose Escalation Cell Therapy Trial DS-316See metadata
PharmaSUG2025paper·US·Data StandardsCreating JSON Transport Data for Regulatory Life Sciences DS-336See metadata
PharmaSUG2025paper·US·Data StandardsEfficient CDISC Controlled Terminology Mapping: An R-Based Automation Solution DS-338See metadata
PharmaSUG2025paper·US·Data StandardsGetting under the ‘umbrella’ of Specimen-based Findings Domains! DS-346See metadata
PharmaSUG2025paper·China·Data Standards and Submission (DS)Implementation of the Estimand Framework to Oncology Project with Time-to-Event Endpoints DS-107 ShanghaiSee metadata
PharmaSUG2025paper·China·Data Standards and Submission (DS)From Statistical Programmer's Desk: Conquering FDA Inspections with Effective Quality Control Measures DS-122 ShanghaiSee metadata