PharmaSUG2017paper·US·Data Standards
Ahead of the Curve: Leading with Industry Data Requirements DS10
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PharmaSUG2017paper·US·Data Standards
Leveraging metadata when mapping to CDISC Standards with SAS® machine learning in a Results as a Service plus Model (RAAS+) DS11
PharmaSUG2017paper·US·Data Standards
Considerations and Conventions in the Submission of the SDTMIG Tumor and Response Domains DS12
PharmaSUG2017paper·US·Data Standards
Planning to Pool SDTM by Creating and Maintaining a Sponsor-Specific Controlled Terminology Database DS13
PharmaSUG2017paper·US·Data Standards
Considerations in Submitting Standardized Electronic Data Under the Animal Rule: The Use of Domains in the SDTMIG and the SENDIG DS14
PharmaSUG2017paper·US·Data Standards
ADaM Grouping: Groups, Categories, and Criteria. Which Way Should I Go? DS17
PharmaSUG2017paper·US·Data Standards
Clarifications About ADaM Implementation Provided in ADaMIG Version 1.1 DS18
PharmaSUG2017paper·US·Data Standards
Standardized, Customized or Both? Defining and Implementing (MedDRA) Queries in ADaM Data Sets DS19
PharmaSUG2017paper·US·Data Standards
LBTEST/LBSTRESU and ADaM lab parameters: The dilemma of mapping one-to-many or many-to-one DS20
PharmaSUG2017paper·US·Data Standards
Programming Efficiency in the Creation of ADaM BDS Datasets DS21
PharmaSUG2017paper·US·Data Standards
The Benefits of Traceability Beyond Just From SDTM to ADaM in CDISC Standards DS23
PharmaSUG2017paper·US·Data Standards
ADQRS: Basic Principles for Building Questionnaire, Rating and Scale Analysis Datasets DS24
PharmaSUG2017paper·US·Data Standards
A Critique of Implementing the Submission Data Tabulation Model (SDTM) for Drugs and Medical Devices DS25
PharmaSUG2017paper·China·Data Standards/CDISC and Regulatory Submission
How to define Treatment Emergent Adverse Event (TEAE) in crossover clinical trials CD-01 Shanghai
PharmaSUG2017paper·China·Data Standards/CDISC and Regulatory Submission
Introduction to Therapeutic Area Data Standards User Guide for QT Studies (TAUG-QT) CD-02 Shanghai
PharmaSUG2017paper·China·Data Standards/CDISC and Regulatory Submission
Constructive Practice of Generating ADaM Datasets CD-03 Shanghai