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PharmaSUG2019paper·US·Data Standards
Strategy to Evaluate the Quality of Clinical Data from CROs DS-087
PharmaSUG2019paper·US·Data Standards
Pacemaker Guy: De-Mystifying a Business Use Case for SDTM Standard and Medical Device Domains DS-088
PharmaSUG2019paper·US·Data Standards
Common Pinnacle 21 Report Issues: Shall we Document or Fix? DS-119
PharmaSUG2019paper·US·Data Standards
Considerations when Representing Multiple Subject Enrollments in SDTM DS-146
PharmaSUG2019paper·US·Data Standards
Bidirectionality to LOINC: Handling the Nitty Gritty of Lab Data DS-151
PharmaSUG2019paper·US·Data Standards
Leveraging Intermediate Data Sets to Achieve ADaM Traceability DS-185
PharmaSUG2019paper·US·Data Standards
Practical Guide for Creating ADaM Datasets in Cross-over Studies DS-196
PharmaSUG2019paper·US·Data Standards
This Paper focuses on CDISC Questionnaires, Ratings and Scales (QRS) supplements and types of FDA Clinical Outcome Assessments DS-202
PharmaSUG2019paper·US·Data Standards
Homogenizing Unique and Complex data into Standard SDTM Domains with TAUGs DS-223
PharmaSUG2019paper·US·Data Standards
Timing is Everything: Defining ADaM Period, Subperiod and Phase DS-250
PharmaSUG2019paper·US·Data Standards
Raising the Bar: CDASH implementation in a biometrics CRO DS-261
PharmaSUG2019paper·US·Data Standards
Considerations and Updates in the Use of Timing Variables in Submitting SDTM-Compliant Datasets DS-304
PharmaSUG2019paper·US·Data Standards
Using CDISC Standards with an MDR for EDC to Submission Traceability DS-308