From FDA to PMDA submission: How to resolve CDISC non-compliance issues
Source category: Submission Standards
THE COMMUNITY ARCHIVE
PharmaSUG 2023 Papers ArchivePage 3
Browse indexed publications from PharmaSUG in 2023. Material labels distinguish papers, presentations, posters and proceedings listings where the source provides them.
209 papers · Showing 81–120
From Sea to shining sea – End to End discussion on PR and LB data
Source category: Data Standards
Author collections: Abraham Yeh
Gear up the Metadata – Automating Patient Profile Generation, a Metadata Driven Programming Approach
Source category: Metadata Management
Author collections: Tanmay Khole · Lili Li
Generating Clinical Graphs in SAS and R – A Comparison of the Two Languages
Source category: Hands-On Training
Author collections: Kriss Harris · Endri Elnadav
Get a GPS to navigate your skills to find career purpose
Source category: Leadership Skills
Author collections: Charu Shankar · Lisa Mendez
Going Command(o): Power(Shell)ing Through Your Workload
Source category: Advanced Programming
Author collections: Richann Watson · Louise Hadden
Guidelines for the Statistical Analysis in German Dossier Submissions
Source category: Statistics and Analytics
Handling Anti-Drug Antibody (ADA) Data for Efficient Analysis
Source category: Data Standards
Author collections: Sabarinath Sundaram · Johnny Maruthavanan
Handling CRS/NT Data in CAR-T Studies and Submission
Source category: Submission Standards
Author collections: Joe Xi · Yuanyuan Liu
Handling of Vaccine SDTM Data for FDA CBER/OVRR Submission Compliance
Source category: Submission Standards
Author collections: Pragathi Mudundi · Zhaoyu Xie
Hard Coding: What is it? Why Does It Matter? What Should You Do When Faced With Such A Request?
Source category: Data Standards
Author collections: Michael Nessly
Have a Date with ISO®? Using PROC FCMP to Convert Dates to ISO 8601
Source category: Advanced Programming
Author collections: Richann Watson
Have Meaningful Relationships: An Example of Implementing SDTM Special Purpose Data Set RELREC with a Many-to-Many Relationship
Source category: Data Standards
Author collections: Richann Watson
How Can I Put This? – Using a pre-defined spreadsheet to explain your Pinnacle 21 Enterprise Issues
Source category: Submission Standards
Author collections: Mike Lozano
How to generate questionnaire data compliance report
Source category: Quick Programming Tips
Author collections: Phaneendhar Gondesi
How to Promote Yourself
Source category: Freelancers Forum
Author collections: Josh Horstman
Implementing Agile Methodologies: Using Trello™ to Generate and Optimize Kanban Boards for Recurring SAS Programming Tasks
Source category: e-Posters
Author collections: Gina Boccuzzi · Patrick Dowe
Importance of Creating a Learning Portal for Statistical Programming End-to-End Processes
Source category: Solution Development
Author collections: Yogesh Pande
Industry metrics for standards utilization and validation rules
Source category: Submission Standards
Author collections: Sergiy Sirichenko
Integrated Trial Design Model Datasets?
Source category: Data Standards
Author collections: Christine McNichol
Integrating Practices: How Statistical Programmers Differ and Align Within User Groups
Source category: Strategic Implementation & Innovation
Author collections: Valeria Duran · Radhika Etikala
Introducing TFL Designer: Community Solution to Automate Development of Mock-up Shells and Analysis Results Metadata
Source category: Hands-On Training
Author collections: Bhavin Busa
Introduction of AWS Cloud Computing and its future for Biometric Department
Source category: Strategic Implementation & Innovation
Author collections: Kevin Lee
Introduction of Developing Resistance Dataset
Source category: Solution Development
Author collections: Jenny Zhang · Shunbing Zhao
IRS Audits – How to Beat Them
Source category: Freelancers Forum
Key Safety Assessments following Chimeric Antigen Receptor (CAR) T-cell Therapy in Early Development Oncology
Source category: Strategic Implementation & Innovation
Author collections: Tamara Martin
Key Statistical Programming Considerations in External Collaborative Clinical Trials
Source category: Strategic Implementation & Innovation
Author collections: James Zhao · Hong Qi · Mary Varughese
Lessons Learned from a Retired SAS® Programmer
Source category: Leadership Skills
Author collections: Carey Smoak
Let the Data Drive it and set your hands free – A Macro to create indicators for Special Interest AEs
Source category: Quick Programming Tips
Author collections: Jameson Cai
Leverage and Enhance CDISC TAUGs to Build More Traceability for and Streamline Development of Efficacy ADaM in Oncology Studies
Source category: Data Standards
Author collections: Xiangchen Cui
Life Table Analysis for Time to First Event Onset
Source category: Data Visualization and Reporting
Author collections: Abhinav Srivastva
Low Code Approach to Clinical Application Development using SAS Studio Custom Step
Source category: Solution Development
Author collections: David Olaleye
Macro Code to Test Existence of Various Objects
Source category: Quick Programming Tips
Author collections: Ronald Fehd
Macro to Automate Creation and Sync of Shell Document and TOC
Source category: Metadata Management
Author collections: Karen Walker
Macro To Automate Crossover Review In Produced Outputs
Source category: Advanced Programming
Author collections: Igor Goldfarb · Ella Zelichonok
Make You Holla’ Tikka Masala: Creating User-Defined Informats Using the PROC FORMAT OTHER Option To Call User-Defined FCMP Functions That Facilitate Data Ingestion Data Quality
Source category: Advanced Programming
Author collections: Troy Hughes
Making Multilingual Programmers – A Targeted Approach to R for Clinical Trials Training
Source category: Strategic Implementation & Innovation
Author collections: Jagan Mohan Achi · Ashley Tarasiewicz
Making Publication Metric Tracking Easy: Using an Automated, Integrated System of R, SAS®, and Microsoft Power BI to Ease the Pain of Assessing Publication Metrics
Source category: Solution Development
Author collections: Joshua Cook
Masters of the Table Universe: Creating Table Shells Consistently and Efficiently Across All Studies
Source category: Metadata Management
Author collections: Michael Hagendoorn · Ran Li
Meta-Analysis in R
Source category: Data Visualization and Reporting