RT Journal Article
SR Electronic
T1 The Importance of Standard Operating Procedures in Clinical Trials
JF Journal of Nuclear Medicine Technology
JO J. Nucl. Med. Technol.
FD Society of Nuclear Medicine
SP 231
OP 233
DO 10.2967/jnmt.113.121467
VO 41
IS 3
A1 Rebecca Sajdak
A1 LisaAnn Trembath
A1 Kathy S. Thomas
YR 2013
UL http://tech.snmjournals.org/content/41/3/231.abstract
AB 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.