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Conference Papers
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PharmaSUG2017paper·US·Data Standards
The Untapped Potential of the Protocol Representation Model DS01
PharmaSUG2017paper·US·Data Standards
SDTM – Just a Walk in the (Theme) Park, Exploring SDTM in the Most Magical Place on Earth DS03
PharmaSUG2017paper·US·Data Standards
The CDISC Trial Design Model (TDM), the EPOCH variable, and the Treatment Emergent Flag: How to Leverage these to Improve Review DS04
PharmaSUG2017paper·US·Data Standards
Implementation of STDM Pharmacogenomics/Genetics Domains on Genetic Variation Data DS05
PharmaSUG2017paper·US·Data Standards
Harmonizing CDISC Data Standards across Companies: A Practical Overview with Examples DS06
PharmaSUG2017paper·US·Data Standards
Where Is the Link Broken – Another Look at SDTM Oncology Tumor Packages DS07
PharmaSUG2017paper·US·Data Standards
The CDISC SDTM Exposure Domains (EX & EC) Demystified. How EC Helps You Produce A Better (more compliant) EX. DS08
PharmaSUG2017paper·US·Data Standards
Ahead of the Curve: Leading with Industry Data Requirements DS10
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