Standard operating procedures for clinical research personnel—part 6

Abstract

AbstractThis is the sixth 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 Organisations (CROs). The procedures include those required by the International Conference on Harmonisation (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, three SOPs for the management of investigator brochures including preparation (SOP 301), review, approval and amendment (SOP 302) and distribution (SOP 303) are addressed. A sample of the format and contents of an investigator brochure is also included. (The full text of all 101 SOPs is available from the authors.) Copyright © 2001 John Wiley & Sons, Ltd.