High-quality COVID Vaccine Submission at Lightning Speed
Source category: Submissions & Agencies
Author collections: Helen Yang
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 15
Browse practical work on assembling, validating and documenting clinical data for regulatory review. Conference examples reflect their publication date; consult current agency guidance when deciding how an approach applies to a new submission.
622 papers · Showing 281–300
How a Clinical Metadata Repository Facilitates Compliance with Industry Standards and Expedites Metadata Storage, Sharing, Analysis and Submission Times
Source category: Standards Implementation
Author collections: Gilbert Hunter
How Disclosure Teams Are Collaborating and Embracing the Changes Imposed by Global Transparency Regulations
Source category: Submissions & Agencies
Author collections: Elliot Zimmerman
Implementation of Real-world Structured/ Unstructured Clinical Data in Real-world Evidence Trials (RWEs) for Regulatory Submissions
Source category: Real-world Evidence
Author collections: Ravi Mokkarala · Yan Shen
Including Population Information in ADaM define.xml for Better Understanding of Datasets
Source category: Submission Standards
Author collections: Hong Qi · Majdoub Haloui · Guowei Wu
Is Your Analytics Platform Ready for Handling Real-world Data for Regulatory-grade Real-world Evidence?
Source category: Real-world Evidence
Author collections: William Kuan · Olivier Bouchard
Lessons Learned from Using P21 to Create ADaM define.xml with Examples
Source category: Submission Standards
Author collections: Yizhuo Zhong · Christine Teng · Majdoub Haloui
Leveraging Manifest Files for Impact Analysis: Preparing Studies for Critical Deliverables (Interim/Final Run/Submissions)
Source category: Poster Presentations
Metadata-driven Case Report Tabulation for Regulatory Submissions
Source category: Data Standards & Governance
Author collections: Jacques Lanoue
Modelling Electrocardiogram Waveform Interpretations for SEND Submissions
Source category: Poster Presentations
Author collections: Jack Baker
Overcoming Challenges of Your Integrated Summary ISS/ISE Submissions
Source category: Data Standards & Governance
Author collections: Akhil Vijayan
Preparing Vaccine Studies for Regulatory Submissions
Source category: Submissions & Agencies
Author collections: Kristin Kelly
R And SAS in Analysis Data Reviewer’s Guide and Data Visualization
Source category: Data Visualization and Reporting
Author collections: Fan Lin
R for Submission – Experiences from the R Consortium Working Group
Source category: Submissions & Agencies
Author collections: Ari Siggaard Knoph
Real Time Oncology Review Readiness from Programming Perspective
Source category: Submission Standards
Author collections: Binal Mehta · Patel Mukesh
Standardised SAS Macro Considerations for Submission-ready Code
Source category: Coding Tips & Tricks
Author collections: Will Greenway
Submission Readiness
Source category: Submissions & Agencies
Author collections: Ali Dootson
Submission Standards for RWD: The Good, the Bad and the Ugly
Source category: Real-world Evidence
Author collections: Jeffrey Abolafia · Ingeborg Holt
The Art of Work Flowing Your Clinical Submission Scripts
Source category: Analytics, Big Data & Statistics
Author collections: Brian Varney · Kevin Putschko
The Bioresearch Monitoring Data Reviewer’s Guide (BDRG)
Source category: Submissions & Agencies
Author collections: Julie Maynard