Standard operating procedures for clinical research personnel - Part 7

Abstract

This is the seventh in a series of articles containing proposals for wording and content of standard operating procedures (SOPs) for clinical research activities conducted by sponsors and Contract Research Organizations (CROs). The procedures include those required by the International Conference on Harmonization (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and 'best practice' observed by the authors. The model forms require modification for actual use. In this article, SOPs are presented for the management of protocols and protocol amendments including preparation and format (SOPs 304 and 307), review, approval and amendment (SOPs 305 and 308) and distribution (SOPs 306 and 309). (The full text of all 101 SOPs is available from the authors.) Copyright © 2001 John Wiley & Sons, Ltd.