Understanding the Japanese culture and approval process
Source category: Regulatory Compliance, Electronic Submission & Validation
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 37
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.
747 papers · Showing 721–740
Welcome to Dullsville!! The System Testing of SAS Macros
Source category: Regulatory Compliance, Electronic Submission & Validation
Author collections: James McGiffen
A Table-Driven Solution for Clinical Data Submission
Source category: Conference paper
Regulatory Overview of Using SAS/IntrNet® to Collect Data from Thousands of Users
Source category: Conference paper
Author collections: Russell E. Denslow
Regulatory Review of Animal Carcinogenicity Studies Using SAS/IntrNet®
Source category: Conference paper
Author collections: Ted J. Guo
Preparing the SAS Software Programming Environment for Regulatory Submission
Source category: Conference paper
Author collections: Sunil K. Gupta
Standards for Electronic Submissions to FDA
Source category: Conference paper
Author collections: Kay Obenshain
Using New SAS Features Meeting Requirements for Submission in Electronic Format
Source category: Applications Development
Author collections: Karen Walker
A Submission Development Environment to Support SAS Programming and Related Activities During Clinical Data Analysis
Source category: Conference paper
Author collections: Barry R. Cohen
Creating Case Report Tabluations (CRTs) for an NDA Electronic Submission
Source category: Applications Development
Author collections: Anita Rocha · Paul D. Hamilton
Creating Case Report Tabulations (CRTs) for an NDA Electronic Submission to the FDAAnita
Source category: Conference paper
Preparing the SAS Software Programming Environment for Regulatory Submission
Source category: Conference paper
Author collections: Sunil K. Gupta
Preparing the SAS Software Programming Environment for Regulatory Submission
Source category: Data Warehousing and Database Management
Author collections: Sunil Kumar Gupta
SAS, Trialex, an Intranet, and Adobe Acrobat 4.0, Could this be a FDA Electronic Submission?
Source category: Internet, Intranets, and the Web
Author collections: David Eber
A Client/Server Solution Using the SAS System for Electronic Submissions to the FDA
Source category: Conference paper
Author collections: Russell R. Holmes
ClinAccess: An Integrated Client/Server Approach to Clinical Data Management and Regulatory
Source category: Data Warehousing and Database Management
Author collections: Martin J. Rosenberg
ClinAccess: An Integrated Client/Server Approach to Clinical Data Management and Regulatory Approval
Source category: Conference paper
Author collections: Martin J. Rosenberg
ClinAccess: A Client/Server Approach to Clinical Trials Data Management and Regulatory Approval
Source category: Conference paper
Author collections: Martin J. Rosenberg
ClinAccess: An Integrated Client/Server Approach to Clinical Data Management and Regulatory Approval
Source category: Applications Development
Author collections: Martin J. Rosenberg
A Case Study in the Use of SAS/PH-Clinical for an Electronic Regulatory Submission of a Megatrial
Source category: Conference paper
Author collections: Kathy R. Boussina · Dorene M. Emmrich · Alan Hopkins