Addressing AML Regulatory Pressures by Creating Customer Risk Rating Models with Ordinal Logistic Regression
Source category: Conference presentation
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 31
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 601–620
Begin with the End in Mind – Using FDA Guidance Documents as Guideposts when Planning, Delivering and Archiving Clinical Trials
Source category: Submission Standards
Author collections: David C. Izard
DIABETES: Submission Data Standards and Therapeutic End Points
Source category: Data Standards
Exploratory Analysis vs Regulatory Reporting
Source category: Poster Presentations
Getting Loopy with SAS® DICTIONARY Tables: Using Metadata from DICTIONARY Tables to Fulfill Submission Requirements
Source category: Submission Standards
Author collections: Jeanina Worden
Getting Rid of Bloated Data in FDA Submissions
Source category: Submission Standards
Author collections: Ben Bocchicchio
Japanese submission/approval processes from programming perspective
Source category: Submission Standards
Author collections: Ryan Hara
OSI Packages: What you need to know for your next NDA or BLA Submission
Source category: Submission Standards
Regulatory Compliance Reporting Using SAS® XML Mapper
Source category: Conference presentation
Regulatory Stress Testing--A Manageable Process with SAS®
Source category: Conference presentation
Regulatory Stress Testing—A Manageable Process with SAS®
Source category: Banking and Finance
File inside source ZIP: SESUG 2015 Final paper PDF Files 11_2_2015/Banking_Finance/195_Final_PDF.pdf
Reporting Of Treatment Emergent Adverse Events Based On Pooled Data Analysis or Country Specific Submissions: A Case Study
Source category: Posters
The publisher lists this abstract, but its numbered PDF is missing or unreadable in the original ZIP.
SAS® Tools for Working with Dataset-XML files
Source category: Submission Standards
Author collections: Lex Jansen
The Most Common Issues in Submission Data
Source category: Submission Standards
Author collections: Sergiy Sirichenko · Max Kanevsky
Tips on Creating a Strategy for a CDISC Submission
Source category: Industry Basics
Using SAS® Clinical Data Integration to Roundtrip a Complete Study Study Metadata (Define-XML) and Study Data (Dataset-XML)
Source category: Submission Standards
A Road Map to Successful CDISC ADaM Submission to FDA: Guidelines, Best Practices & Case Studies
Source category: Data Standards
Author collections: Vikash Jain · Sandra Minjoe
CDISC Electronic Submission
Source category: Data Standards
Author collections: Kevin Lee
Considerations in the Submission of Exposure Data in SDTM-Based Datasets
Source category: Data Standards
Author collections: Fred Wood · Jerry Salyers · Richard Lewis · Kristin Kelly
Creating Define.xml v2 Using SAS® for FDA Submissions
Source category: Applications Development
Author collections: Qinghua (Kathy) Chen