SEND Implementation Wiki
Welcome to the SEND Implementation Wiki!
The SEND Implementation Wiki is a knowledge base on implementing SEND - a series of articles designed to help you understand and implement SEND, including modeling basics, useful links, FAQs, and more.
In addition to the wiki, the companion SEND Implementation Forum is a place for active discussion and to ask questions not already answered in the wiki.
What Is SEND?
SEND, or the Standard for Exchange of Nonclinical Data, is an implementation of the CDISC Standard Data Tabulation Model (SDTM) which specifies a way to present nonclinical data in a consistent format.
By having a common model to which the industry can conform, many benefits can be realized, such as inter-company exchange that is consistent in format regardless of the parties involved, the ability for vendors to develop tools, and many others.
A SEND package consists of a few parts, but the main focus is on individual endpoint data. Endpoints typically map to domains (essentially, datasets), with a number of variables (a.k.a., columns or fields).
Keep up to date with SEND developments!
New to SEND? These pages will introduce you to the model:
- SEND Fundamentals - Basics on SEND, such as what it is, where to find the implementation guide, and how to use it
- CT Fundamentals - Basics on Controlled Terminology, such as what it is and where to find it
- Define.xml Fundamentals - Basics on the define.xml, such as what it is and key links and preparation information
Ok, so you need to implement SEND. Here are some pages that will help:
- Getting SEND-ready - A guide for new implementers, with such information as where to start, things to consider, etc.
- FAQ - Frequently Asked Questions, with answers to many questions
- Known Issues - A list of key known issues
- SEND Implementation Forum - a place to ask questions and receive answers from SEND experts
- FDA Study Data Standards - resources page from the FDA with helpful links
- CDISC SEND - This page has links to the SEND implementation guide and Controlled Terminology
- SEND Implementation Wiki CSS Poster - This is the SEND Implementation Wiki poster presented at CSS Silver Spring, 2016
For more links, see the Resources page.
Interested in contributing? These pages give information on working with the wiki pages.
- Wiki FAQ - For general tips on how to work with wiki pages
- SEND Implementation Wiki Contributor Guide - For specifics on contributing to the SEND Implementation Wiki
The content of this wiki is brought to you by the SEND Implementation User Group.
Last revision by Brian.argo, 2016-04-12