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 - For updates in the SEND world SEND Implementation Forum - 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
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