Regulatory Update & Townhall
Source category: Regulatory Environment
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 18
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 341–360
Regulatory Update & Townhall
Source category: Regulatory Environment
Author collections: Ethan Chen
Shiny App for Generating Data Dependency Flowchart in ADRG
Source category: Submission Standards
Author collections: Simiao Ye · Yilong Zhang
Software Demonstration: Freedom or Regulatory Compliance? Have Both, in a Language-agnostic Statistical Computing Environment – Sponsored by Entimo
Source category: Technology & Applications
Author collections: Jörn Bilow
Standing Room Only: SA04: Diversity, Equity and Inclusion of Your Submission Package
Source category: Submissions & Agencies
Standing Room Only: SA07: Programming Pooled Safety Data for Ongoing Oncology Submissions
Source category: Submissions & Agencies
Author collections: Sarah Berenbrinck
Template of Analysis Reviewer’s Guide in Oncology
Source category: Standards Implementation
Author collections: Hong Qi · Mary Varughese
The Case for Pandemic-disrupted Studies and Challenges Implementing CDISC and FDA COVID-19 Guidelines for NDA Submissions
Source category: Regulatory Environment
Author collections: Vidya Muthukumar
The JumpStart Traceability Assessment
Source category: Submissions & Agencies
Author collections: Jesse Anderson
Transitioning to R for Clinical Submissions
Source category: Programming Languages
Author collections: Phil Bowsher · Sean Lopp
Using Real-world Data in Supporting Health Authority Submission
Source category: Analytics and Statistics
10 things you need to know about PMDA eSubmission
Source category: ePosters
Author collections: Yuichi Nakajima
A Case Study: Data Transparency of Clinical Trial Data
Source category: Submissions & Agencies
A Programmer's Journey through the BIMO Submission Process
Source category: Analytics, Big Data & Statistics
Author collections: Raghavender Ranga
A Rose By Any Other Name – Our Experience with an RTOR-like Neuroscience Filing
Source category: Submissions & Agencies
Author collections: Emma Moore
An Update on CDISC-SEND Data Submissions to the FDA
Source category: Submissions & Agencies
Author collections: Christopher Bartlett · Jesse Anderson
Analysis Package e-Submission – Planning and Execution
Source category: Submission Standards
Author collections: Abhilash Chimbirithy · Saigovind Chenna · Majdoub Haloui
Analysis Studio: A Tool Framework for Supporting Regulatory Review
Source category: Software Demonstration
Author collections: Joy Li
Are We There Yet? Evaluating New Non-EDC Data Sources for Clinical Trial Submission Feasibility
Source category: Data Handling
Author collections: Allison Covucci · Vijay Pasapula
Automating CRF Annotations using Python
Source category: Submission Standards
Author collections: Kobie O’Brian · Julie Stofel