Standard operating procedures for clinical research personnel – Part 18

Abstract

AbstractThis is the 18th 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, SOPs are presented for management of study medications/devices: receipt of study medications/devices at study sites ( SOP 504); control of study medications/devices at study sites (SOP 505); assessment of compliance with use of study medications/devices (SOP 506) and return of study medications/devices from study sites (SOP 507). (The full text of all 101 SOPs is available from the authors.) Copyright © 2003 John Wiley & Sons, Ltd.