title: The importance of standard operating procedures in clinical trials.
abstract: This special contribution provides insight into the role that standard operating procedures (SOPs) play in an imaging department and their value in building a high-quality research site. If you have ever participated in a clinical trial, many of the principles described in this article should be familiar. However, this article goes a step further by presenting information from a pharmaceutical or device sponsor's point of view-what the sponsor expects from a site during the course of a research study. This article is intended not to provide a complete set of instructions on how to create a great SOP but, instead, to present guidelines to ensure that the key elements are included. After reading the article, you will be able to define SOPs as they pertain to the clinical trial environment, describe key components of an SOP, list the clinical research SOPs that exist in your institution and imaging department, identify which additional SOPs might improve site performance, and describe how the sponsor relies on SOPs to ensure that the highest quality of research is attained.
authors.affiliation: Department of Radiology, Division of Nuclear Medicine, Loyola University Medical Center, Maywood, IL, USA. rsajdak@lumc.edu
authors.forename: Rebecca
authors.initials: R
authors.lastname: Sajdak
authors.forename: Lisaann
authors.initials: L
authors.lastname: Trembath
authors.forename: Kathy S
authors.initials: KS
authors.lastname: Thomas
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D017410:Practice Guidelines as Topic; D012015:Reference Standards
keywords: PET; good clinical practices; molecular imaging; protocol; research methods; statistics