This article is within the scope of WikiProject United States, a collaborative effort to improve the coverage of topics relating to the United States of America on Wikipedia. If you would like to participate, please visit the project page, where you can join the ongoing discussions.
This document is critical to the practice, and history, of clinical trial management and EDC; at a time when the relationship of 21 CFR Part 11 and 21 CFR Part 820 was unclear with regard especially to the validation of CTMS and EDC systems (which were at that time in their infancy), this document became a standard by which EDC providers were audited, and was used as a basis for requirements specifications for EDC systems. Please don't consider this as insufficiently noteworthy. Someone will want to flesh this out with more information and some real references some day. Tolken (talk) 13:39, 4 November 2008 (UTC)