Statistical Programming Team Contributions for RWE Regulatory Submissions
Source category: Poster Presentation
Author collections: Norihiko Oharu
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 21
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 401–420
Strategies for Writing the ADRG
Source category: Standards Implementation
Author collections: Ari Siggaard Knoph
Successful US Submission of Medical Device Clinical Trial using CDISC
Source category: Medical Devices
Author collections: Phil Hall
Supplementary Steps to Create a More Precise ADaM define.xml in Pinnacle 21 Enterprise
Source category: Submission Standards
Author collections: Majdoub Haloui · Hong Qi
The Good? The Bad? Or the Ugly? CDISC eSubmission Packages in Practice
Source category: Submissions & Agencies
The JumpStart Traceability Assessment
Source category: Submissions & Agencies
The Misery of the Miscellaneous Folder in Module 5
Source category: Submissions & Agencies
Updates in SDTM IG V3.3: What Belongs Where – Practical Examples
Source category: Submission Standards
Author collections: Todd Case
Why Are There So Many ADaM Documents, and How Do I Know Which to Use?
Source category: Submission Standards
Author collections: Sandra Minjoe
A Practical Guide to the Issues Summary in the Data Conformance Summary of Reviewer’s Guides
Source category: Submission Standards
Author collections: Gary Moore
A Standardized Data Sample: Key to Improving the Submission Strategy
Source category: Submission Standards
Author collections: Prafulla Girase · Joanna Koft
An Automated, Metadata Approach to Electronic Dataset Submissions
Source category: Submission Standards
Author collections: Janette Garner
Automate the Process to Ensure the Compliance with FDA Business Rules in SDTM Programming for FDA Submission
Source category: Applications Development
Author collections: Xiangchen (Bob) Cui · Min Chen · Letan (Cleo) Lin
Automate the Process to Ensure the Compliance with FDA Business Rules in SDTM Programming for FDA Submission
Source category: Conference presentation
Automating SAS Program Table of Contents for Your FDA Submission Package
Source category: Advanced Programming
Author collections: Lingjiao Qi · Bharath Donthi
China NMPA (National Medical Products Administration) reform and new regulations/guidelines/requirements
Source category: Submission Standards
Author collections: Yi Yang
Clinical Development Standards for FDA Bioresearch Monitoring (BIMO) Submissions
Source category: Submission Standards
Author collections: Julie Maynard
Considerations in Effectively Generating PK Analysis Input Datasets
Source category: Submission Standards
Author collections: Jianli Ping
Create True Load Sharing Facility Batch Job Submission Capability on SAS® Enterprise Guide® in a SAS® Grid
Source category: Conference presentation
CRO Oversight: Regulatory Submission Point of View
Source category: Industry Solutions
The publisher's PDF link currently returns 404; the conference abstract remains available.
Author collections: Aakar Shah and Tracy Sherman