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trial elements

60 papers and 6 presentations; 62 titles.

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Conference × Year × Title × Authors Extras Pages
PharmaSUG 2026 Bridging the Gap: Table-Driven SAS Programming as a Pathway to AI in Clinical Trials Statistical Programming James Sun,
Vijaya Nadella,
Daniel Qi
source 15
PharmaSUG 2026 Goodbye SAS, Hello R: Practical Workflows for CDISC Standards Madeleine Penniston,
Alyssa M. Wittle
source 12
PharmaSUG 2026 The Tipsy Hangover: Avoiding Indent Headaches in SAS Reports Lisa A. Mendez,
Richann J. Watson
source 22
PharmaSUG 2025 Clopper Pearson CI? get your data ready for it! Ruth Marisol Rivera Barragan,
Isaac Vazquez
source 7
PHUSE US 2025 Advancing Safety Evaluation in Oncology Trials Using Estimands Reshma Radhakrishnan,
Lakshmi Mantha
source
presentation source
8
PharmaSUG CN 2024 Return to baseline status of the worst elevated liver function tests Yuan Sun,
Tingting Zhang
source 10
PharmaSUG 2024 Demystifying Incidence Rates: A Step-by-Step Guide to Adverse Event Analysis for Novice Programmers Yuting Peng,
Ruohan Wang
source 10
PharmaSUG 2024 PHUSE Safety Analytics Working Group - Overview and Deliverables Update Nancy Brucken,
Mary Nilsson,
Greg Ball
source 5
PharmaSUG 2023 OCS Update: OCS Clinical Services & the Traceability Assessment Jesse Anderson source 25
PharmaSUG 2023 PHUSE Safety Analytics Working Group - Overview and Deliverables Update Nancy Brucken,
Clio Wu,
Mary Nilsson,
Greg Ball
source 5
PharmaSUG 2023 R Tables via GT for Regulatory Submissions Philip Bowsher source 19
PHUSE US 2023 ADAE Design for Multiple Phase Trial Deepak S. Grewal source
presentation source
4
WUSS 2022 Cautionary Notes when Working with Interim Data Bill Coar source 8
PHUSE US 2022 'Verify Outputs' Product Demonstration: Validation of Statistical Outputs Using Automation [presentation] Ilan Carmeli,
Yoran Bar
source
video
17
PHUSE US 2022 The Emerging Use of Automation to Address the Challenge of Cross-Table Consistency Checking of Output Used in the Reporting of Clinical Trial Data [presentation] Hugh Donovan,
Naama Feilchenfeld
source
video
16
PHUSE US 2022 Volcano Plot for Adverse Event Analysis in R [presentation] Kamleshkumar Patel source
video
15
PHUSE EU 2021 Standing Room Only: SA07: Programming Pooled Safety Data for Ongoing Oncology Submissions [presentation] Sarah Berenbrinck source 36
PHUSE EU 2020 Preparing for FDA and PMDA Submission Simultaneously - What to Leverage, How to Deal with the Differences Efficiently [presentation] Jasmine Kestemont source
video
22
PharmaSUG 2020 SUPPQUAL Datasets: Good Bad and Ugly Sergiy Sirichenko source 14
PHUSE US 2020 Adverse Event and Treatment Emergent Approaches in the Industry Aimee Basile source
poster source
11
PHUSE US 2020 Interactive Adverse Event Data Visualization Using R Shiny Aditya Rachoori,
Mukul K Mittal
source 9
PHUSE US 2020 SUPPQUAL Datasets: Good Bad and Ugly Sergiy Sirichenko,
Blue Bell
source
presentation source
13
PHUSE US 2020 The JumpStart Traceability Assessment Tejas Patel,
Sarah Ferkov
source 10
PHUSE EU 2019 Use of FHIR in Clinical Research: From Electronic Medical Records to Analysis Jeffrey M. Abolafia,
Priya Gopal,
Samuel Hume
source
presentation source
12
PharmaSUG 2019 Common Pinnacle 21 Report Issues: Shall we Document or Fix? Ajay Gupta source 11
PharmaSUG 2019 Flagging On-Treatment Events in a Study with Multiple Treatment Periods David W. Franklin source 4
PHUSE US 2019 Effective Presentations of CTCAE-graded Laboratory Data William Coar,
Amber Randall
source
presentation source
7
PHUSE US 2019 Use of FHIR in Clinical Research: From Electronic Medical Records to Analysis Priya Gopal source
presentation source
12
PHUSE US 2019 Voice-based Clinical Monitoring Assistant Anoop Ambika source
presentation source
7
PHUSE EU 2018 Adverse Event Data - gRaphically Lina Rajput,
Prajakta Chitale
source
presentation source
10
PHUSE US 2018 Adverse Event Analysis - One step forward! Anuja Rasal source
presentation source
11
PharmaSUG 2018 Analyzing Adverse Events of Special Interest using Lab Tests and Toxicity Grades Vamsi Krishna Medarametla,
Liz Thomas,
Gokul Vasist
source 6
PHUSE EU 2017 Adverse Events Data Over Time Kriss Harris source
presentation source
11
PHUSE EU 2017 Detecting Treatment Emergent Adverse Events (TEAEs) Matthias Lehrkamp source
presentation source
12
WUSS 2017 Maintaining ORDER in Your (PROC) Reporting Bill Coar source 5
PharmaSUG CN 2017 How to define Treatment Emergent Adverse Event (TEAE) in crossover clinical trials Mengya Yin,
Wen Tan
6
PharmaSUG 2017 A Case of assessing adverse events of interest based on their grade changes Sriramu Kundoor source 7
PharmaSUG 2017 Adverse Event Data over Time Kriss Harris source 11
PharmaSUG 2017 Beyond - Just fix it!- Application of Root Cause Analysis Methodology in SAS Programming. Nagadip Rao source 8
PharmaSUG 2017 Common Programming Errors in CDISC data Sergiy Sirichenko source 9
PharmaSUG 2017 How to define Treatment Emergent Adverse Event (TEAE) in crossover clinical trials Mengya Yin,
Wen Tan
source 6
PharmaSUG 2017 The CDISC Trial Design Model (TDM), the EPOCH variable, and the Treatment Emergent Flag: How to Leverage these to Improve Review Thomas Guinter source 4
PharmaSUG 2016 Summarizing Adverse Events of Interest - Onset, Duration, and Resolution John Saida Shaik,
Avani Kaja
source 6
SESUG 2015 Reporting of treatment emergent adverse events based on pooled data Analysis or Country Specific Submissions: A case study Sheetal Shiralkar source 8
PharmaSUG CN 2015 Reading and Resolving OpenCIDSC Message [presentation] Yu Pang 23
PharmaSUG 2015 TEAE: Did I flag it right? Arun Raj Vidhyadharan,
Sunil Mohan Jairath
source 5
PHUSE EU 2014 FLIPFLOP the Data: To Check Sustained Timepoint Occurrences Rucha Landge source
presentation source
8
PharmaSUG 2014 Common and Comparative Incidence Indicators of Adverse Events for Well-Defined Study Pools John R. Gerlach source 7
SESUG 2013 Imputing Dose Levels for Adverse Events John R. Gerlach,
Igor Kolodezh
source 8
PharmaSUG 2013 Designing and Tuning ADaM Datasets Songhui Zhu source 9
PharmaSUG 2013 Flags for Facilitating Statistical Analysis Using CDISC Analysis Data Model Chun Feng,
Xiaopeng Li,
Nancy Wang
source 6
PharmaSUG 2013 Imputing Dose Levels for Adverse Events John R. Gerlach,
Igor Kolodezh
source 8
PharmaSUG 2012 Giving Data a Voice: Partnering with Medical Writing for Best Reporting Practices Katherine Troyer,
Brit Minor
source 8
PHUSE EU 2011 FDA CDER Common Data Standards Issues: Evolution of SDTM Submission Standards Peter Van Reusel,
Tina Apers
source
presentation source
3
MWSUG 2011 Fuzzy Merges - A Guide to Joining Data sets with Non-Exact Keys Using the SAS SQL Procedure Robert W. Graebner 5
MWSUG 2011 Is It Time to Upgrade CDISC SDTM from v1.1/v3.1.1 to v1.2/v3.1.2? Susan M. Fehrer 3
PharmaSUG 2011 Basic Understanding on SE Domain for Beginners Gayatri Karkera source 4
PharmaSUG 2011 Creating a Customized Graph for Adverse Event Incidence and Duration Sanjiv Ramalingam source 7
PHUSE EU 2010 The Ultimate Integration Challenge Jennifer Choon-Moi Chin,
Hester Schoeman
source
presentation source
11
NESUG 2006 Standard SAS Macros for Standard Date/Time Processing Qin Lin,
Timothy D. Kelly
18
PharmaSUG 2005 Everything You Always Wanted to Know About Fuzzy Merges But Were Afraid to Ask - A Guide to Merging Datasets with Non-Exact Keys Using SAS Proc SQL Robert W. Graebner 4
PharmaSUG 2004 CDX - clinical data management and report programming environment Gunilla Sköllermo,
Pål Edman
7
PharmaSUG 2004 Using a Decision Table to Program Complex Date Logic Arthur Collins 4
NESUG 2003 Date/Time Stamped Files and Audit Trails: What Part 11 Compliant SAS Systems are Made Of Carolyn Dougherty 11
PharmaSUG 2002 The 800-Pound Gorilla: Taking on the Challenge of Globally Standardizing Adverse Event and Medication Reporting Deborah Harper,
Jennifer Tjernagel
4
PharmaSUG 1997 Adverse Events Summary Tables in Clinical Trials: Incorporating P-values Using SAS Macros and SAS/AF Incorporating P-values 10

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