A retrospective pilot study comparing data from monitoring reports to identify staffing influence on protocol deviation rates

Authors

  • Carolynn Jones Ohio State University, Columbus OH http://orcid.org/0000-0002-0669-7860
  • Cheryl Fisher NIH Clinical Center, Bethesda MD
  • Catherine A. Griffith Massachusetts General Hospital, Translational and Clinical Research Centers, Boston, MA
  • Joy Bailey Emory University, Atlanta, GA
  • Candida Barlow St. John Health System, Tulsa OK
  • Georgie Cusack NHLBI, NIH, Bethesda MD
  • Kathleen Grinke Massachusetts General Hospital, Translational and Clinical Research Centers, Boston, MA
  • Kathryn E. Hall Massachusetts General Hospital, Translational and Clinical Research Centers, Boston, MA
  • Rosemary Keller Pfizer, Collegeville, PA
  • Elyce Turba H. Lee Moffitt Cancer Center, Tampa, FL
  • Penelope Jester Center for Clinical and Translational Sciences, University of Alabama at Birmingham, Birmingham, AL

DOI:

https://doi.org/10.18203/2349-3259.ijct20180128

Keywords:

Clinical research nurse, Research nurse coordinator, Clinical research coordinator, Delegation of authority, Protocol deviations, Scope of practice, Protocol violations

Abstract

Background: Clinical research sites are hiring more non-licensed personnel to coordinate clinical trials and to replace licensed nurse counterparts. Revised regulatory documents heavily emphasize research staff training and research activity delegation of authority. The Scope and Standards of Practice for Clinical Research Nursing, published by the American Nurses’ Association and based on role delineation studies for nurses, is the guidance document for clinical research nurses participating in research activities. Policy making related to research activity delegation of authority would be informed by data that correlate protocol deviation rates with licensure and education of research staff. Protocol deviations can lead to invalid clinical trial results, adverse events, and ethical concerns related to participant risk exposure. Outcome data are lacking, which directly compare frequency of protocol deviations by licensed nurse study coordinators to deviation rates of non-licensed study coordinators.

Methods: This pilot study reviewed 45 monitoring reports for 3 clinical research studies and associated research sites staffed with licensed RN study coordinators and research sites staffed with non-licensed, non-RN study coordinators to compare deviation rates related to informed consent, protocol endpoints, participant eligibility and adverse events.

Results: We identified 101 deviations. Adverse event and endpoint deviations were the highest frequency. Differences were evident in overall deviation rates; however, specific deviation comparisons failed to show statistical significance due to low sample size.  

Conclusions: This study illustrates a useful method for planning future studies using monitoring reports for deviation tracking and comparison across staffing levels.

Author Biographies

Carolynn Jones, Ohio State University, Columbus OH

Carolyn Thomas Jones, DNP, MSPH, RN is Associate Professor with The Ohio State University College of Nursing and the Lead Faculty for the Master’s in Applied Clinical and Pre-Clinical Research (MACPR) Clinical Research Management Specialty and Core Courses.  Dr. Jones has nearly 30 years experience as a clinical research professional.  She is a member of the Joint Task Force for Harmonized Clinical Research Core Competencies and has a research interest in nursing roles in the clinical research enterprise.  

Cheryl Fisher, NIH Clinical Center, Bethesda MD

Senior Nurse Consultant

NIH Clinical Center

Catherine A. Griffith, Massachusetts General Hospital, Translational and Clinical Research Centers, Boston, MA

Clinical Research Nurse

Translational Research Centers

Joy Bailey, Emory University, Atlanta, GA

Director

Emory Healtcare and ACTSI

Candida Barlow, St. John Health System, Tulsa OK

Director of Research

St. John Health System

Georgie Cusack, NHLBI, NIH, Bethesda MD

Director of Education and Outcomes

National Heart Lung and Blood Institute

Kathleen Grinke, Massachusetts General Hospital, Translational and Clinical Research Centers, Boston, MA

Clinical Research Nurse

Translational Clinical Research Centers

Kathryn E. Hall, Massachusetts General Hospital, Translational and Clinical Research Centers, Boston, MA

Nurse Director

Translational Clinical Research Centers

Rosemary Keller, Pfizer, Collegeville, PA

Clinical Research Manager

Elyce Turba, H. Lee Moffitt Cancer Center, Tampa, FL

Senior Clinical Trials Coordinator

Penelope Jester, Center for Clinical and Translational Sciences, University of Alabama at Birmingham, Birmingham, AL

Director of Research

Center for Clinical and Translational Sciences 

School of Medicine

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Published

2018-01-23

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Section

Original Research Articles