Good Data Validation Practice
Source category: Submission Standards
Author collections: Sergiy Sirichenko · Max Kanevsky
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 29
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 561–580
Good versus better SDTM: Including Screen Failure Data in the Study SDTM?
Source category: Submission Standards
Author collections: Henry Winsor · Mario Widel
How will FDA Reject non-CDISC submission?
Source category: Submission Standards
Author collections: Kevin Lee
Implementing JumpStart at Novo Nordisk A/S
Source category: Regulatory
Innovation and Regulatory Review: What is JumpStart?
Source category: FDA Wednesday
Author collections: Alan Shapiro
Leverage Automation to Accelerate the Creation of Submission-ready Artifacts
Source category: Standards Implementation
The publisher-listed Slides file is currently unavailable.
Author collections: Lourdes Devenney
Leveraging Study Data Reviewer’s Guide (SDRG) in Building FDA’s Confidence in Sponsor’s Submitted Datasets
Source category: Submission Standards
Author collections: Xiangchen (Bob) Cui · Min Chen · Letan (Cleo) Lin
Overview and Application of the HCV Vertical Resistance Analysis Template
Source category: Submission Standards
Preparing Analysis Data Model (ADaM) Data Sets and Related Files for FDA Submission
Source category: Submission Standards
Author collections: Sandra Minjoe
Preparing Analysis Data Model (ADaM) Data Sets and Related Files for FDA Submission with SAS®
Source category: Conference presentation
Author collections: Sandra Minjoe
Quality Check your CDISC Data Submission Folder Before It Is Too Late!
Source category: Submission Standards
Author collections: Bhavin Busa
The Do’s/Don’ts, An SDTM Validation Perspective. The should/shouldn’t when explaining issues in the Study Data Reviewers Guide
Source category: Submission Standards
Author collections: Thomas Guinter
The Impact of Regulations on Immuno-OncologySubmissions
Source category: Regulatory
Author collections: Geoffrey Mann
Use of Traceability Chains in Study Data and Metadata for Regulatory Electronic Submission
Source category: Submission Standards
A Data Preparation Primer: Getting Your Data Ready for Submission
Source category: Posters
Author collections: Janet Stuelpner
A Practical Approach to Re-sizing Character Variable Lengths for FDA Submission Datasets (both SDTM and ADaM)
Source category: Submission Standards
Author collections: Xiangchen (Bob) Cui · Min Chen
A SAS® Macro Tool to Automate Generation of Define.xml V2.0 from SDTM Specification for FDA Submission
Source category: Submission Standards
Author collections: Min Chen · Xiangchen (Bob) Cui
Achieving Clarity through Proper Study Documentation: An Introduction to the Study Data Reviewer’s Guide (SDRG)
Source category: Submission Standards
Author collections: Michael Stackhouse
Automatic Consistency Checking of Controlled Terminology among SDTM Datasets, Define.xml, and NCI/CDISC Controlled Terminology for FDA Submission
Source category: Posters
Author collections: Min Chen · Xiangchen (Bob) Cui
Case Study in Support of German Payer Evidence
Source category: Regulatory