Standard operating procedures for clinical research personnel ‐ Part 16

Abstract

AbstractThis is the 16th 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 internal review of case report forms and data: initial internal CRF review (after retrieval to sponsor/CRO) (SOP 405); data correction after retrieval from study sites (SOP 406); database development, review and lock (SOP 407); and statistical review (SOP 408). SOPs are also presented for management of CROs (SOP 409) and clinical laboratories during studies (SOP 410). (The full text of all 101 SOPs is available from the authors.) Copyright © 2003 John Wiley & Sons, Ltd.