If a published clinical outcome assessment is within scope of the project, the team should follow the CDISC QRS process. This process includes a review of applicable questionnaires and scales used and initiates the process for collecting the required copyright permissions. The QRS Representative expands the initial gap analysis, identifies questionnaires that are needed and initiates the process for acquiring permissions. The QRS Representative reviews the list of instruments with the Clinical Expert and identifies those that need development.
It is mandatory that permission be acquired for use of any diagrams or figures in the standard from other sources. No diagram or figure may be used without the expressed permission from the copyright holder, unless it is created by the CDISC team or is in the public domain. See CDISC Operational Procedure 017 for more information.