CT16 A Macro Tool to Reduce the Size of the Regulatory Submission Dataset
Source category: Coding Tips & Tricks
Author collections: Venkata Madhira
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 22
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 421–440
De-Identification of Data & It’s Techniques
Source category: Submission Standards
Designing Flexible Data Standards Models
Source category: Submission Standards
Author collections: Melissa Martinez
Do-It-Yourself CDISC! A Case Study of Westat’s Successful Implementation of CDISC Standards on a Fixed Budget
Source category: Submission Standards
Author collections: Rachel Brown · Jennifer Fulton · Stephen Black
DS09 Send 3.1: Giving Your Submission a 'Vital' Upgrade
Source category: Data Standards and Governance
Enforcing Standards in an Organization: A Practical 6 Step-Approach
Source category: Submission Standards
Author collections: Priscilla Gathoni
Expediting Drug Approval: Real Time Oncology Review Pilot Program
Source category: Submission Standards
Author collections: Laxmi Samhitha Bontha
Exploring Common CDISC ADaM Conformance Findings
Source category: Submission Standards
Author collections: Trevor Mankus
Framework for German Dossier Submissions
Source category: Submission Standards
Author collections: Kriss Harris
Framework for German Dossier Submissions
Source category: Conference presentation
Have You Met Define.xml 2.0?
Source category: Submission Standards
Author collections: Christine McNichol
How to use SUPPQUAL for specifying natural key variables in define.xml?
Source category: Submission Standards
Author collections: Sergiy Sirichenko
Information Requests During An FDA Review
Source category: Submission Standards
Author collections: Hong Qi
ISS Challenges and Solutions for a Compound with Multiple Submissions in Parallel
Source category: Strategic Implementation, Business Administration, Support Resources
Author collections: Aiming Yang
Making Lab Toxicity Tables Less Toxic on Your Brain
Source category: Submission Standards
Author collections: Lindsey Xie · Jinlin Wang · Richann Watson
Multiple Studies BIMO Submission Package – A Programmer’s Perspective
Source category: Submission Standards
Next Innovation in Pharma – CDISC data and Machine Learning
Source category: Submission Standards
Author collections: Kevin Lee
Non-Clinical (SEND) Reference Guide for Clinical (SDTM) Programmers
Source category: Submission Standards
Author collections: Dharmendra Tirumalasetti · Bhavin Busa
Panel Discussion: Medical Devices – Implementation Through Submission
Source category: Data Standards
Author collections: Fred Wood · Carey Smoak · Donna Sattler · Karin LaPann · Mike Lozano · Karl Miller
Panel Discussion: Recent Submission Experiences around the World
Source category: Submission Standards
Author collections: Carey Smoak · Kriss Harris · Marianne Carames · Yi Yang · David Izard · Karin LaPann