A Case Study in Using Unit Testing as a Method of Primary Validation
Source category: Regulatory
Author collections: Ross Farrugia
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 34
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 661–680
Facilitating Data Integration for Regulatory Submissions
Source category: Data Handling
Author collections: John Gerlach · John Bowen
Good Clinical Practices or "Why we do What we do the Way we do it"
Source category: Regulatory
Author collections: Elaine Dempsey
How much is it? Validation of Open-Source Software using the example of R
Source category: Regulatory
Author collections: Peter Bewerunge
Risk Radar for the Outsourcing of Clinical Trials: The Best Guide for Success
Source category: Regulatory
Validation Strategies for Report Objects and Programs - Challenges and Obstacles in a Risk Based World
Source category: Regulatory
Author collections: Christoph Ziegler · Beate Hientzsch
Vendor Selection & Management in GxP critical IT projects - a validation perspective (based on actual case)
Source category: Regulatory
24 Hour Challenge
Source category: Regulatory
Author collections: Michael Whitworth
Acceleration through Collaboration
Source category: Regulatory
Author collections: Carrie Eason
BRIDGing CDASH to SAS: How Harmonizing Clinical Trial and Healthcare Standards May Impact SAS Users
Source category: CDISC Methodologies for FDA Submissions
CDISC for the Medical Device and Diagnostic Industry: An Update
Source category: CDISC Methodologies for FDA Submissions
Author collections: Carey G. Smoak
CDISC Implementation on a Rheumatoid Arthritis Project Partnership
Source category: CDISC Methodologies for FDA Submissions
Author collections: Patricia L. Gerend · Chris Price · Olivier Leconte · Michelle Zhang
ClinicalTrials.gov- a programmers perspective
Source category: Regulatory
Author collections: Ralf Minkenberg
CRT for eCTD submission
Source category: Regulatory
Data review: To see or not to see..
Source category: Regulatory
Database/Biostatistics Audits - from the Auditor's Perspective
Source category: Regulatory
Experiences and lessons learned from a first SDTM submission project
Source category: CDISC and Industry Standards
Author collections: Paul Vervuren · Bas van Bakel
From raw data to submission: A metadata-driven, repository-based process of data conversion to CDISC
Source category: CDISC and Industry Standards
Author collections: Dimitri Kutsenko
Health Authority questions: how to deal with the diversity
Source category: Regulatory
How a SAS/IntrNet tool was created at the FDA for the detection of potential drug-induced liver injury using data with CDISC standard
Source category: CDISC Methodologies for FDA Submissions
Author collections: Ted J. Guo