Abstract
AbstractThis is the ninth 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 the initial selection process for suitable study sites (SOP 315), study site selection visits (SOP 316), assessment of Phase I facilities (SOP 317), documentation of qualifications of investigators and other site personnel (SOP 318) and final authorisation to use a study site (SOP 319). (The full text of all 101 SOPs is available from the authors.) Copyright © 2001 John Wiley & Sons, Ltd.
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