Standard Operating Procedures for Clinical Research Coordinators
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Drug Informarion Journal. Vol. 36. pp. 369-377, 2002 Printed in the USA. All tights reserved.
STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH COORDINATORS RUTH ANN FRIES,BS, CIP Clinical Research Coordinator, Hamot Research Center, Erie, Pennsylvania
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 spec@ requirements of individual institutions. Key Words: Clinical research coordinators; Standard operating procedures; Manual;Clinical trials; Processes
INTRODUCTION ADOPTING WRITTEN STANDARD operating procedures (SOPs) is rapidly becoming a standard requirement when contract research organizations and sponsors select sites for clinical trials. Often, well-established processes are in place; however, they may not have been reduced to writing. Clinical research coordinators may find that allocating time for development of a procedure manual is difficult as they frequently are hard-pressed to fulfill other responsibilities. That clinical research coordinators function in multiple roles only increases the challenge. Yet, having an SOP manual provides benefit to coordinators, especially when they are training new personnel. A model SOP manual for clinical research coordinators was developed. This manual provides a working framework for institutions drafting their own SOPs.
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Reprint address: Ruth Fries, BS, CIP, Hamot Research Center, 104 E. 2nd St., Erie, PA 16507. E-mail: Ruth.Fries @Hamot.org.
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MATERIAL AND METHODS Sponsor criteria and applicable federal regulations were utilized to develop the manual. These federal regulations included those impacting the informed consent process (21 CFR, Part 50 [ l ] and 45 CFR Part 46 [2]); institutional review boards (21 CFR, Part 56 [3] and 45 CFR Part 46); Investigational New Drugs (21 CFR, Part 312 [4]); and significant/ nonsignificant risk devices (21 CFR, Part 812[5]).
MODEL STANDARD OPERATING PROCEDURES MANUAL This manual was designed to assist clinical research coordinators (CRCs) in the performance of their duties. It is not a substitute for professional education, training, and experience. The clinical research coordinators should be available for consultation, as needed. I. Clinical Re
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