SA08 Identifying Hurdles for Submission of Electronic Nonclinical Data (SEND)
Source category: Submissions & Agencies
Author collections: Lou Ann Kramer
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 24
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 461–480
SA09 Impact of SEND Data on FDA Review of Nonclinical Studies
Source category: Submissions & Agencies
Author collections: Kevin Snyder
SA10 Using CDISC-SEND Standardized Data in FDA Toxicology Review: The KickStart Service
Source category: Submissions & Agencies
Author collections: Jesse Anderson · Christopher Bartlett
SA13 The Clinical Data Specialist Role Within Regulatory Review
Source category: Submissions & Agencies
Author collections: Joy Li
SA15 FDA View: Update on Study Data Submission
Source category: Submissions & Agencies
Author collections: Ethan Chen · Lilliam Rosario
SA17 Streamlining the Results Reporting for ClinicalTrials.gov and EudraCT
Source category: Submissions & Agencies
Author collections: Susruth Ganoothula
SD11 Managing Complexity Towards Submission
Source category: Software Demonstrations
Author collections: Johannes Ulander
SI05 Fake it Till You Make it with Global SDTM Laboratory Submissions
Source category: Standards Implementation
Author collections: Éanna Kiely
SI06 Ensuring Consistent and Supported Standards Across Data and Metadata in a Large Regulatory Filing is Tricky Business
Source category: Standards Implementation
Author collections: Lisa Brooks
Sponsor Considerations for Building a Reviewer’s Guide to Facilitate BIMO (Bioresearch Monitoring) Review
Source category: Submission Standards
Author collections: Kiran Kundarapu · Janet Low · Majdoub Haloui
The Anatomy of Clinical Trials Data: A Beginner’s Guide
Source category: Submission Standards
Author collections: Venky Chakravarthy
The Evolution of FDA Regulatory Submissions in the PDUFA Era
Source category: FDA Wednesday
The Need for Therapeutic Area User Guide Implementation
Source category: Submission Standards
Author collections: Michael Beers
Using CDISC Standards with an MDR for EDC to Submission Traceability
Source category: Data Standards
Author collections: Paul Slagle · Eric Larson
Validating Medicare Beneficiary Identifier Submissions
Source category: Coder’s Corner (10-minute presentation)
File inside source ZIP: Coders_Corner/SESUG2019_Paper-119_Final_PDF.pdf
"What's Rules Got to Do with It?"
Source category: Regulatory
Author collections: Helena Sviglin
A CRO’s perspective on successful partnering to deliver SDTM/SEND contributions
Source category: Submission Standards
A Framework for Implementing [Conflicting] FDA Guidance
Source category: Submission Standards
Author collections: Todd Case
A Macro to Avoid P21 FDAC036 Error Message for Regulatory Submission Datasets
Source category: Industry Solutions
Author collections: Venkata Madhira · Prabhakara Burma
A Macro to Create Program Inventory for Analysis Data Reviewer’s Guide
Source category: Quick Tips
Author collections: Xianhua Zeng