PT  - JOURNAL ARTICLE
AU  - Rebecca Sajdak
AU  - LisaAnn Trembath
AU  - Kathy S. Thomas
TI  - The Importance of Standard Operating Procedures in Clinical Trials
AID  - 10.2967/jnmt.113.121467
DP  - 2013 Sep 01
TA  - Journal of Nuclear Medicine Technology
PG  - 231--233
VI  - 41
IP  - 3
4099  - http://tech.snmjournals.org/content/41/3/231.short
4100  - http://tech.snmjournals.org/content/41/3/231.full
SO  - J. Nucl. Med. Technol.2013 Sep 01; 41
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.