Project teams should take reasonable steps to ensure applicable regulatory guidance and requirements, such as those in The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use regions (http://www.ich.org), and other regulatory requirements are taken into account. The Clinical TA Expert and Project Manager must verify that all applicable regulations are taken into account in the standard under development and that such regulatory documents are referenced in the appendix of the standards document.
The FDA is working to provide requirements for each standard. However, some projects may not have FDA requirements at the time of inception. The project team collaborates with the FDA liaison who identifies FDA reviewers to review the draft standard. The goal is to ensure that FDA reviewer needs are considered in the development the standard.
For projects where FDA requirements are available, the following guidelines apply. CDISC is not at liberty to use text nor publicly attribute the FDA requirements document. FDA must follow a legal process which includes posting FDA generated documents and guidelines on the Federal Register (FR). So caution must be observed. Listing FDA representatives in the team member list in the appendix of the standard is determined on a case by case basis. Permission must be obtained by the FDA. It is important to work with the program manager.
Another resource that should be consulted is the Clinical Outcome Assessment Compendium.