Creating Define-XML version 2 including Analysis Results Metadata with the SAS® Clinical Standards Toolkit
Source category: Submission Standards
Author collections: Lex Jansen
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 30
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 581–600
Delivering a quality CDISC compliant accelerated submission using an outsourced model
Source category: Posters
Author collections: Mei Dey · Diane Peers
Importance of Niche Provider for Successful NDA Submission: Rescue Case Study
Source category: Industry Basics
Author collections: Aparna Poona · Bhavin Busa · Tim Southwick
Japanese Electronic Submission in CDISC Formats
Source category: Regulatory
Author collections: Takashi Kitahara
New Features in Define-XML V2.0 and Its Impact on SDTM/ADaM Specifications
Source category: Submission Standards
Author collections: Hang Pang
On the Fast Lane to a Successful Submission - A Lead Programmer’s Guide to Efficient, High-quality Submission Programming Deliverables
Source category: Professional Development & Training
Author collections: Hannes Engberg Raeder
Pinnacle 21 Enterprise - Facilitating eSubmission PreparationMax Kanevsky, Pinnacle 21
Source category: Software Demonstrations
The publisher-listed Paper file is currently unavailable.
Author collections: Max Kanevsky
Planning for Data-reporting Processes for Submission: Key Considerations
Source category: Regulatory
Author collections: Parag Shiralkar
Preparing Legacy Format Data for Submission to the FDA – When & Why Must I Do It, What Guidance Should I Follow?
Source category: Submission Standards
Author collections: David C. Izard
Strategic Considerations for CDISC Implementation
Source category: Submission Standards
Author collections: Amber Randall · William Coar
Submission-Ready Define.xml Files Using SAS® Clinical Data Integration
Source category: Submission Standards
Author collections: Melissa R. Martinez
The Standard for the Exchange of Nonclinical Data (SEND): History, Basics, and Comparisons with Clinical Data
Source category: Submission Standards
Author collections: Fred Wood
To IDB or Not to IDB: That is the Question
Source category: Submission Standards
Author collections: Kjersten Offenbecker
Up-Versioning Existing Define.xml from 1.0 to 2.0
Source category: Submission Standards
Author collections: Jeff Xia
UTF What? A Guide to Using UTF-8 Encoded Data in a SDTM Submission
Source category: Beyond the Basics
Author collections: Michael Stackhouse
What Auditors Want
Source category: Regulatory
Author collections: Angelo Tinazzi · Cedric Marchand
What is high quality study metadata?
Source category: Submission Standards
Author collections: Sergiy Sirichenko · Max Kanevsky
What is High-quality Study Metadata?
Source category: Regulatory
Author collections: Sergiy Sirichenko
A SAS® Macro Tool to Automate Generation of Define.xml V2.0 from ADaM Specification for FDA Submission
Source category: Applications Development
Author collections: Min Chen · Xiangchen (Bob) Cui
ADaM Reviewer's Guide - Interpretation and Implementation
Source category: CDISC and Industry Standards
Author collections: Steve Griffiths