Confusing Data Validation Rules Explained
Source category: Submission Standards
Author collections: Michael Beers
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 26
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 501–520
Confusing Data Validation Rules Explained
Source category: Regulatory
Author collections: Michael Beers
Core and Extension studies – Challenges and solutions towards SDTM submission
Source category: Data Standards
Author collections: Murali Marneni
define.xml (noun): Fear Inducing Task for SAS Programmers
Source category: Submission Standards
Author collections: Kjersten Offenbecker · Antonio Cardozo · Kirsty Lauderdale
Diagnostics of technical errors in define.xml file
Source category: Submission Standards
Author collections: Sergiy Sirichenko
Dos and Don'ts of Define-XML
Source category: Submissions & Agencies
Electronic Data Submission and Utilization in Japan
Source category: Regulatory (FDA/PMDA)
eSubmission – Are you really Compliant?
Source category: Submission Standards
Author collections: Majdoub Haloui
Experience of electronic data submission via Gateway to PMDA
Source category: ePosters
FDA CBER Data Standards Activity Update
Source category: Regulatory
Author collections: Lisa Lin
FDA View: Technical Rejection Criteria for Study Data
Source category: Regulatory
Author collections: Ethan Chen · Lilliam Rosario
FDALabel Database: Enabling Insights from Drug Labeling to Advancement of Drug Safety and Regulatory Sciences
Source category: Regulatory
Author collections: Crystal Allard
Guideline for Submission-ready aCRF
Source category: Poster Presentation
How FDA will reject non-CDISC submission
Source category: Industry Solutions
Author collections: Kevin Lee
How to Easily Generate Define.pdf from Define-XML – Submission Request
Source category: Submissions & Agencies
Author collections: Endri Elnadav
How to Prepare High Quality Metadata for Submission
Source category: Standards Implementation
The publisher-listed Paper file is currently unavailable.
Author collections: Varun Debbeti
Improving Metadata Compliance and Assessing Quality Metrics with a Standards Library
Source category: Submission Standards
Author collections: Veena Nataraj · Erica Davis
Is it Possible to Make a Global CDISC Submission?
Source category: Submissions & Agencies
Author collections: Marianne Carames
It’s all about getting the Source and Codelist Implementation right for ADaM Define.xml v2.0
Source category: Submission Standards
It's Time To Change
Source category: Regulatory
The publisher-listed Slides file is currently unavailable.
Author collections: David Iberson-Hurst