Implementation of ADaM standards NOT driven by a submission
Source category: CDISC and Industry Standards
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 35
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 681–700
Implementation of CDISC Standards at Nycomed
Source category: Regulatory
Industry Standard Good Programming Practice for Clinical Trials (using SAS)
Source category: Regulatory
Author collections: Mark Foxwell
Requirements, Specifications and Programming – How to … cooperate with Statisticians in an effective way … accelerate the production of report objects … create technical specifications out of programs
Source category: Regulatory
Talking Past Each Other? How to Communicate with Medical Writers When Preparing Clinical Research Manuscripts for Journal Submission
Source category: Pharma, Life Sciences and Healthcare
Author collections: Stephanie R. Thompson
The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics
Source category: CDISC Methodologies for FDA Submissions
The Second CDISC Pilot Project: A Metastandard for Integrating Databases
Source category: CDISC Methodologies for FDA Submissions
Author collections: Gregory C. Steffens · Ian Fleming
Automatic Unit Testing of SAS programs with SASUnit
Source category: Regulatory
Author collections: Andreas Mangold
Automating Production of Validation Documentation
Source category: Regulatory
Author collections: Tangi Sanséau
Developing a clinical reporting system collaboratively under an Open Source software license.
Source category: Regulatory
Drug Safety Reporting - now and then
Source category: Regulatory
Author collections: David Garbutt
RECIST Temptation
Source category: Regulatory
Author collections: Paul Jenkins
Risk Based Approach Applied to the Validation of Report Objects
Source category: Regulatory
Author collections: Christoph Ziegler
Seven Steps to Regulatory Publication Style With Proc Report
Source category: Data Presentation and Business Intelligence
Author collections: Dennis Gianneschi
Validation of Clinical Output: More Quality with Less Effort
Source category: Regulatory
Author collections: Jules van der Zalm
A SAS based solution for define.xml
Source category: CDISC and Regulatory
Author collections: Monika Kawohl
All roads lead to SDTM - which one shall we take?
Source category: CDISC and Regulatory
Considerations for CDISC implementation
Source category: CDISC and Regulatory
Electronic submissions - the role of the programmer
Source category: CDISC and Regulatory
Keynote Presentation: Standards for Clinical Research from Protocol Through Submission: CDISC Business Case and Progress Report
Source category: Conference paper