Page History

Note
This page was recently migrated, and its contents are under review.

Common Resources in the SEND World
CDISC/SEND Links
CDISC SEND - This page has links to the SEND Implementation Guide and Controlled Terminology SEND Implementation News (BROKEN LINK; WILL BE FIXED) - For updates in the SEND world SEND Implementation Forum (BROKEN LINK; WILL BE FIXED) - For asking questions about SEND Implementation
FDA Links
FDA Study Data Standards Resources - with various resource links Study Data Standards for Submission to CDER - with some additional information related to submissions to CDER SEND at FDA (BROKEN LINK; MAY BE RETIRED) - with timing and information of usage at various FDA divisions (CDER, CVM, CBER, etc.)
FDA Draft Guidances and Federal Registry Notices for Electronic Submissions
FDA Newly Added Guidance Documents FDA Study Data Technical Conformance Guide - see FDA Study Data Standards Resources for most up-to-date link FDA Data Standards Catalog - see FDA Study Data Standards Resources for most up-to-date link Providing Regulatory Submissions in Electronic Format - Standardized Study Data (Most recent Guidance and Register Notice linked from here) - aka Docket FDA-2012-D-0097 Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (Most recent Guidance and Register Notice linked from here) - aka FDA-2014-D-0085

Page tree