Standard operating procedures for clinical research personnel – Part 19

Abstract

AbstractThis is the nineteenth 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 and randomisation procedures: final disposition of study medications/devices (SOP 508); recall of investigational products (SOP 509); reallocation of investigational products between study sites (SOP 510); requesting and preparing randomisation schedules (SOP 511); revealing randomisation code assignments during studies (SOP 512) and revealing randomisation code assignments after study completion (SOP 513). (The full text of all 101 SOPs is available from the authors.) Copyright © 2004 John Wiley & Sons, Ltd.