The use of standard operating procedures in clinical research trials
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The use of standard operating procedures in clinical research trials

Diana Hull Senior clinical research nurse, Cancer Research UK Institute for Cancer Studies, University of Birmingham
Karen Doyle Lead oncology clinical research nurse, Cancer Research UK Institute for Cancer Studies, University of Birmingham
Ceri Davies Clinical research nurse, Cancer Research UK Institute for Cancer Studies, University of Birmingham

Research nurses need to be familiar with standard operating procedure (SOP) documents. SOPs are distinct from nursing care plans. An SOP is an official, detailed, written instruction for the management of clinical trials; it ensures that all the functions and activities of a clinical trial are carried out consistently and efficiently. This article describes the background to, development and implementation of SOPs for a human gene therapy trial.

Cancer Nursing Practice. 4, 7,29-33. doi: 10.7748/cnp2005.09.4.7.29.c147

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