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

2.50
Hdl Handle:
http://hdl.handle.net/10755/303957
Category:
Abstract
Type:
Presentation
Title:
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
Author(s):
Rozenfeld, Irina Rafailovna; Silverman, Rita; Castejon, Ana Maria
Lead Author STTI Affiliation:
Upsilon Chi
Author Details:
Irina Rafailovna Rozenfeld, MSN, ARNP, CCRP, rozenfel@nova.edu; Rita Silverman, MPS; Ana Maria Castejon, PhD;
Abstract:

Poster presented on: Wednesday, July 24, 2013, Thursday, July 25, 2013

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.
Keywords:
Clinical Research Nurse; Responsibilities; Autism
Repository Posting Date:
22-Oct-2013
Date of Publication:
22-Oct-2013
Conference Date:
2013
Conference Name:
24th International Nursing Research Congress
Conference Host:
Sigma Theta Tau International, the Honor Society of Nursing
Conference Location:
Prague, Czech Republic
Description:
24th International Nursing Research Congress Theme: Bridge the Gap Between Research and Practice Through Collaboration. Held at the Hilton Prague Hotel.
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission.

Full metadata record

DC FieldValue Language
dc.language.isoen_USen_GB
dc.type.categoryAbstracten_GB
dc.typePresentationen_GB
dc.titleThe 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 Centeren_GB
dc.contributor.authorRozenfeld, Irina Rafailovnaen_GB
dc.contributor.authorSilverman, Ritaen_GB
dc.contributor.authorCastejon, Ana Mariaen_GB
dc.contributor.departmentUpsilon Chien_GB
dc.author.detailsIrina Rafailovna Rozenfeld, MSN, ARNP, CCRP, rozenfel@nova.edu; Rita Silverman, MPS; Ana Maria Castejon, PhD;en_GB
dc.identifier.urihttp://hdl.handle.net/10755/303957-
dc.description.abstract<p>Poster presented on: Wednesday, July 24, 2013, Thursday, July 25, 2013</p>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.en_GB
dc.subjectClinical Research Nurseen_GB
dc.subjectResponsibilitiesen_GB
dc.subjectAutismen_GB
dc.date.available2013-10-22T20:26:35Z-
dc.date.issued2013-10-22-
dc.date.accessioned2013-10-22T20:26:35Z-
dc.conference.date2013en_GB
dc.conference.name24th International Nursing Research Congressen_GB
dc.conference.hostSigma Theta Tau International, the Honor Society of Nursingen_GB
dc.conference.locationPrague, Czech Republicen_GB
dc.description24th International Nursing Research Congress Theme: Bridge the Gap Between Research and Practice Through Collaboration. Held at the Hilton Prague Hotel.en_GB
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission.en_GB
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