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Terms and Conditions
CDISC standards in document format are open and freely available for use in clinical research pursuant to the terms below. User agrees to limit access to this download for use within your organization only. All CDISC standards and documentation have been created through the generous contributions of CDISC volunteers and supporters. If your company is currently not among the over 420 pharmaceutical, biotechnology, academic research, CRO, government, and technology service provider organizations who support the CDISC mission and vision and are able to take advantage of the additional benefits of CDISC membership; please consider joining CDISC and/or taking a CDISC educational course to add your support for this vital clinical research effort.
See the CDISC Membership page for details.
These CDISC standards in document format are subject to the Standard License Terms detailed below:
Copyright (c) 2014, CDISC All rights reserved.
“You” means the person or entity downloading this standard.
“Your Organization” means any entity that directly or indirectly controls, is controlled by, or is under common control with You, so long as such control exists. “Control” means direct or indirect beneficial ownership of or the right to exercise (a) more than fifty percent (50%) of the voting stock or equity in You; or (b) more than fifty percent (50%) of the relevant ownership interest or decision-making authority representing the right to make the decisions for You in the event that there is no voting stock or equity. In the event such control ceases to exist, all rights under this Agreement toward such entity shall immediately terminate upon such cessation.
You are hereby granted a nonexclusive, worldwide, perpetual, compensation-free, non- transferable, non-sublicensable license to reproduce, publish, display, and use this standard solely within Your Organization for the purpose of promoting the standard.

For the avoidance of doubt, the foregoing license grant does not include the right to (i) translate or create derivative works of the Material, or (ii) internally or externally copy, distribute, or post to a Web page.
It is possible that implementation of and compliance with this standard may require use of subject matter covered by patent rights. By publication of this standard, no position is taken with respect to the existence or validity of any claim or of any patent rights in connection therewith. CDISC, including the CDISC Board of Directors, shall not be responsible for identifying patent claims for which a license may be required in order to implement this standard or for conducting inquiries into the legal validity or scope of those patents or patent claims that are brought to its attention.
THE STANDARDS ARE PROVIDED BY THE COPYRIGHT HOLDERS, CDISC, AND CDISC’S CONSTITUENT PARTS (INCLUDING, BUT NOT LIMITED THE CDISC PRESIDENT, THE CDISC BOARD OF DIRECTORS, CDISC EMPLOYEES, OR CDISC MEMBERS, PARTICIPANTS, OR REPRESENTATIVES) "AS IS" AND WITHOUT ANY WARRANTIES WHATSOEVER, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, AND THE COPYRIGHT HOLDERS, CDISC, AND CDISC’S CONSTITUENT PARTS (INCLUDING, BUT NOT LIMITED THE CDISC PRESIDENT, THE CDISC BOARD OF DIRECTORS, THE CDISC STAFF, OR CDISC MEMBERS, PARTICIPANTS, OR REPRESENTATIVES) EXPRESSLY DISCLAIM ANY WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, FITNESS FOR A PARTICULAR OR INTENDED PURPOSE, OR ANY OTHER WARRANTY OTHERWISE ARISING OUT OF THE STANDARD.
IN NO EVENT WILL THE COPYRIGHT HOLDERS, CDISC, OR ANY OF CDISC’S CONSTITUENT PARTS (INCLUDING, BUT NOT LIMITED THE CDISC PRESIDENT, THE CDISC BOARD OF DIRECTORS, CDISC EMPLOYEES, OR CDISC MEMBERS, PARTICIPANTS, OR REPRESENTATIVES) BE LIABLE TO ANY OTHER PERSON OR ENTITY FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO LOSS OF PROFITS, LOSS OF USE, OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) RELATING IN ANY WAY TO THE STANDARD, WHETHER OR NOT SUCH PARTY HAD ADVANCE NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.