SEND Implementation Resources

This page was recently migrated and is being updated.

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 SEND at FDA - with timing and information of usage at various FDA divisions (CDER, CVM, CBER, etc.)
FDA Draft Guidances and Federal Registry Notices for Electronic Submissions
(Main page for newly added guidance documents) FDA-2014-D-0092: Study Data Technical Conformance Guide and Data Standards Catalog FDA-2012-D-0097: Guidance: Providing Regulatory Submissions in Electronic Format - Standardized Study Data Registry Notice: FR-2014-02-06 - 2014-02555.pdf FDA-2014-D-0085: Guidance: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act Registry Notice: FR-2014-02-06 - 2014-02553.pdf

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