Standard operating procedures for clinical research personnel – Part 10

Abstract

AbstractThis is the tenth 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 various agreements and contracts which must be in place before studies begin, including protocol agreements (SOP 320), investigator responsibility agreements (SOP 321), financial agreements (SOP 322), payments to study subjects (SOP 323), confidentiality agreements (SOP 324), and insurance and indemnity agreements (SOP 325). (The full text of all 101 SOPs is available from the authors.) Copyright © 2002 John Wiley & Sons, Ltd.