Standard Operating Procedures for Clinical Research Coordinators

Abstract

Clinical research coordinators are specially trained professionals who oversee and manage research trials, ensuring that rigorous standards of the Food and Drug Administration, Office of Human Research Protection, and industry are met. Standard operating procedure manuals are rapidly becoming an industry requirement. Although developing a comprehensive manual is demanding and labor-intensive, it provides structured guidelines for clinical research coordinators implementing clinical trials.

A model standard operating procedure manual for clinical research coordinators is presented that addresses many issues and roles common to coordinators. Industry criteria and applicable federal regulations that impact the informed consent process, institutional review boards, and drug and device studies were utilized to develop the manual. This draft provides a framework that can be formatted to meet the specific requirements of individual institutions.