Standard Operating Procedures for clinical research personnel - part 23

Abstract

This is the twenty-third and final part 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, more SOPs are presented for final activities for closure of a clinical study: preparation of clinical study reports (SOP 703); review, approval and amendment of clinical study reports (SOP 704); distribution of clinical study reports (SOP 705); general procedures for archiving clinical study documents (Sponsors/CROs) (SOP 706); and general procedures for archiving clinical study documents (study sites) (SOP 707). (The full text of all 101 SOPs is available from the authors.) Copyright © 2005 John Wiley & Sons, Ltd.