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protocol amendment

20 papers and 5 presentations; 24 titles.

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Conference × Year × Title × Authors Extras Pages
WUSS 2026 Smarter CRF Reviews: An Open-Source AI Tool for Automated Protocol-to-CRF Gap Analysis in Clinical Trials Raj Sharma source 9
PHUSE US 2026 AI-Driven Metadata Integration in Modern TLF Development Chuck Gelb source
presentation source
4
PHUSE US 2026 CDISC 360i: From Vision to Implementation - Lessons Learned and the Road Ahead [presentation] Peter Van Reusel source 23
PHUSE US 2026 Complex Trials, Simple Disclosures: Streamlined Transparency of Innovative Study Designs [presentation] Ritama Gupta Dempsey source 15
PHUSE US 2026 The Use of Git in Statistical Programming Rita Pecuch,
Jim Coates
source
presentation source
9
PHUSE APAC 2026 Leading Through the Fog: Resilient Technical Leadership in a BANI Clinical World Satya Vyshnavi Thondapu source
presentation source
3
PharmaSUG 2025 Automating Define-XML Updates: A SAS-Based Framework for Submission Readiness Qiong Wei,
Lixin Gao
source 10
PharmaSUG 2025 Automation of Trial Design Domains generation using AI Prasoon Sangwan,
Mayank Bhatia,
Charusheela Thakur,
Shailesh Kumar
source 8
PharmaSUG 2025 Updating Define-XML packages: Tips and A Comprehensive Checklist Qiong Wei,
Ji Qi,
Lixin Gao
source 10
PHUSE US 2025 eProtocol and the Promise of Automation Bill Qubeck,
Suhas Giriraj
source
presentation source
17
PHUSE EU 2024 Responsible AI in Protocol Design for Use in Digital Data Flow Alistair Dootson,
Poorya Amini
source
presentation source
4
PHUSE EU 2024 The TransCelerate/CDISC Digital Data Flow Project: Practical Electronic Study Designs [presentation] David Iberson-Hurst source 8
PharmaSUG 2024 Protocol Amendments and EDC Updates: Downstream impact on Clinical Trial Data Anbu Damodaran,
Ram Gudavalli,
Kumar Bhimavarapu
source 11
PHUSE EU 2023 Standardisation in a fast growing environment; MDR, EDC and other abbreviations Louella Schoemacher,
Jasmine Kestemont
source
presentation source
6
PHUSE US 2022 Advancing RBQM Strategy with Enterprise-level Quality Risk Analytics, NLP/AI, and Immersive Technologies [presentation] Vera Pomerantseva source 20
PharmaSUG 2021 An efficient method to review annotation and create bookmark for case report form (acrf.pdf) using SAS program, FDF files, excel and Javascript in Acrobat Chen-Jung Wu source 12
PHUSE US 2019 ValueListDefs, MethodDefs and WhereClauses: How to Define Data Traceability in a Metadata Repository Judith Goud source
presentation source
11
PHUSE EU 2018 Do's and Don'ts of Define.xml David Roulstone source
presentation source
10
PHUSE EU 2018 Handling CRF Design Changes in a Live Environment Andre Snelting,
Nieke De Ruiter
source
presentation source
10
PHUSE EU 2018 ValueListDefs, MethodDefs and WhereClauses: How to Define Data Traceability in a Metadata Repository Judith Goud source
presentation source
11
PHUSE EU 2017 Futile or Not? An Interim Analysis Case Study Ingrid Franklin source
presentation source
9
PHUSE EU 2016 Effective Use of a Metadata Repository Across Data Operations: The Need for a Machine Readable Form Isabelle de Zegher,
Michele Gray,
Mark Sullivan,
Michael Goedde
source
presentation source
5
PHUSE EU 2014 Drug Exposure Plot: Tailored Approach to Display Ongoing Data Mathias Lebreton source
presentation source
12
PharmaSUG 2009 Nice SUPPQUAL Variables to Have Beilei Xu,
Changhong Shi
5
PHUSE EU 2006 Bringing Clarity To Complexity: The Use Of Data Visualisation [poster] Neville Cope source 1

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