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Mario Widel

28 papers; 28 titles; 15 coauthors.

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Conference × Year × Title × Co-authors Extras Pages
PharmaSUG 2026 Human Beings Still Needed: Manual ADaM Checks that AI Can-t Do Sandra Minjoe source 9
PharmaSUG 2026 Implementing Laboratory Toxicity Grading for CTCAE Version 6 and Beyond Keith Shusterman source 6
PharmaSUG 2026 The Problems Surrounding Rounding Jennifer McGrogan source 12
PharmaSUG 2025 ADaM Fundamental Principles vs. Rules: Which to Follow, When, and Why? Sandra Minjoe source 6
PharmaSUG 2025 Integration Contemplation: Considerations for a Successful ISS/ISE from Planning to Execution Jennifer McGrogan source 8
PharmaSUG 2023 Questionnaires in ADaM: ADSF36 Keith Shusterman,
Megan O'Grady		 source 13
PharmaSUG 2022 A Practical Approach to Preparing Documentation for Clinical Registries Jennifer McGrogan,
Rex Tungala		 source 16
PharmaSUG 2021 Using PROC FCMP to Create Custom Functions in SAS Keith Shusterman source 12
PharmaSUG 2019 Don't Just Rely on Processes; Support Local Subject Matter Expertise Deidre Kreifels,
Steven R. Kirby		 source 7
PharmaSUG 2019 Implementing Laboratory Toxicity Grading for CTCAE Version 5 Keith Shusterman source 11
PharmaSUG 2019 Value-Level Metadata Done Properly Sandra Minjoe source 21
PHUSE US 2019 CDISC Rules + FDA Requests + PMDA Requirements = Guaranteed Compliance? Deborah Goodfellow source 9
PharmaSUG 2018 Preparing to Meet FDA Requirements for Submission of Standardized Data and Documentation Steven R. Kirby source 11
PharmaSUG 2017 Building a Fast Track for CDISC: Practical Ways to Support Consistent, Fast and Efficient SDTM Delivery Steven R. Kirby,
Richard Addy		 source 14
PharmaSUG 2017 Good versus better SDTM: Including Screen Failure Data in the Study SDTM? Henry B. Winsor source 9
PharmaSUG 2016 Good versus Better SDTM: Data Listings Henry B. Winsor source 11
PharmaSUG 2013 Good vs Better SDTM: Limitations as Operational Model Henry B. Winsor source 4
PharmaSUG 2013 Managing 21 CFR Part 11 Compliance: Using Checksums on Opens Systems Carey G. Smoak source 8
SGF 2013 Adding New Rows in the ADaM Basic Data Structure: When and How Sandra Minjoe source 12
SGF 2013 Using the ADaM ADAE Structure for Non-AE Data Sandra Minjoe source 13
PharmaSUG 2012 Checksum Please: A Way to Ensure Data Integrity Carey G. Smoak,
Sy J. Truong		 source 7
PharmaSUG 2012 Clinical Laboratory Results, Old and New Pains Scott A. Bahlavooni source 6
PharmaSUG 2011 Good Versus Better SDTM - Date and Time Variables Henry B. Winsor source 3
PharmaSUG 2011 Success As a Pharmaceutical Statistical Programmer Sandra Minjoe source 7
PharmaSUG 2011 Using the ADaM Basic Data Structure for Survival Analysis Nancy Brucken,
Sandra Minjoe		 source 5
PharmaSUG 2010 Creating SV and Se First Henry B. Winsor 7
PharmaSUG 2007 An Efficient Report Checking Method Xuejing (Susan) Mao 7
PharmaSUG 2006 Techniques for Creating Reviewer-Friendly SAS Programs 6

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