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