The Impact of a Clinical Research Nurse Coordinator on the Implementation of a Principal Investigator-Initiated Randomized Controlled Interventional Study on Children with Autism Spectrum Disorder in an Academic Center

Wednesday, 24 July 2013

Irina Rafailovna Rozenfeld, MSN, ARNP, CCRP
College of Osteopathic Medicine Institute for Neuro-Immune Medicine, Nova Southeastern University, Fort Lauderdale, FL
Ana Maria Castejon, PhD
College of Pharmacy Department of Pharmaceutical Sciences, Nova Southeastern University, Fort Lauderdale, FL
Rita Silverman, MPS
Office of Clinical Research Office of Research and Technology Transfer, Nova Southeastern University, Fort Lauderdale, FL

Learning Objective 1: Define the role of a clinical research nurse coordinator in the development and implementation of an interdisciplinary clinical research project.

Learning Objective 2: Describe the activities of a clinical research nurse coordinator in the implementation of the research project with nutritional supplement on children diagnosed with autism.

This poster describes the role of the clinical research nurse coordinator (CRNC) in the implementation of an interdisciplinary research project that includes a collaboration of investigators from the multiple colleges and departments at Nova Southeastern University. The U.S. Centers for Disease Control and Prevention (CDC) estimates a 78% increase in the prevalence of autism spectrum disorders (ASD) since 2002, and 1 in 88 children has been identified with an ASD (CDC, 2012). A randomized double-blind nutritional intervention using supplementation with cysteine-rich whey protein was designed to investigate the possibility that a safe and easily available nutritional supplement might affect behavior in autistic children. Based on the National Institutes of Health Clinical Center (2009) domain of practice for clinical research nursing specialty, the CRNC’s role was developed to assume the responsibilities for research study management with an emphasis on protocol development, subject recruitment, integrity of collected data, compliance with regulatory requirements, and safety and advocacy for study participants. While conducting an interventional research project on autistic children investigators faced multiple difficulties, including recruitment and retention of children with disabilities, challenges of sample collection, compliance with study protocol in an outpatient design, communication among investigators, and novice of investigators to the clinical research rules and regulations. Having a CRNC on the study team proved to be essential to the successful collaboration between the research team and implementation of the research protocol in a special population in accordance with good clinical practice standards.