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Conference Papers
13,885
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10
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Papers
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PharmaSUG2017paper·US·Submission Standards
Preparing Analysis Data Model (ADaM) Data Sets and Related Files for FDA Submission SS02
PharmaSUG2017paper·US·Submission Standards
Use of Traceability Chains in Study Data and Metadata for Regulatory Electronic Submission SS03
PharmaSUG2017paper·US·Submission Standards
Good versus better SDTM: Including Screen Failure Data in the Study SDTM? SS04
PharmaSUG2017paper·US·Submission Standards
Awareness from Electronic Data Submission to PMDA and FDA — Lesson & Learnt from hands-on experiences — SS06
PharmaSUG2017paper·US·Submission Standards
Overview and Application of the HCV Vertical Resistance Analysis Template SS07
PharmaSUG2017paper·US·Submission Standards
Creating Define-XML version 2 including Analysis Results Metadata with the SAS® Clinical Standards Toolkit SS08
PharmaSUG2017paper·US·Submission Standards
Leveraging Study Data Reviewer’s Guide (SDRG) in Building FDA’s Confidence in Sponsor’s Submitted Datasets SS09
PharmaSUG2017paper·US·Submission Standards
The Do’s/Don’ts, An SDTM Validation Perspective. The should/shouldn’t when explaining issues in the Study Data Reviewers Guide SS10
PharmaSUG2017paper·US·Submission Standards
Documenting Traceability for the FDA: Clarifying the Legacy Data Conversion Plan & Introducing the Study Data Traceability Guide SS11
PharmaSUG2017paper·US·Submission Standards
Quality Check your CDISC Data Submission Folder Before It Is Too Late! SS12
PharmaSUG2017paper·US·Techniques & Tutorials
Building Intelligent Macros: Using Metadata Functions with the SAS® Macro Language TT02
PharmaSUG2017paper·US·Techniques & Tutorials
Check Please: An Automated Approach to Log Checking TT06
PharmaSUG2017paper·US·Techniques & Tutorials
Converting Non-Imputed Dates for SDTM Data Sets With PROC FCMP TT07
PharmaSUG2017paper·US·Techniques & Tutorials
Clinical Trials Data: It’s a Scary World Out There! or Code that Helps You Sleep at Night TT08
