Defense Date


Graduation Date

Summer 8-8-2020

Submission Type


Degree Name

Doctor of Nursing Practice (DNP)


Doctor of Nursing Practice (DNP) Program


School of Nursing

Faculty Mentor

Catherine Johnson, PhD, FNP, PNP

Committee Member

Denise Lucas, PhD, FNP, CRNP

Committee Member

Mary Kay Loughran, MHA, DNP, RN

Committee Member

Manjulata Evatt, DNP, RN, CMSRN

Committee Member

Frank Kosnosky, DNP, RNC, CRNP, NNP, FNP

Committee Member

Mary Ellen Glasgow, PhD, RN, FAAN


workload, workload measurement, clinical trials, clinical research coordinator, clinical research nurse, skill-mix


As the demands for the conduct of clinical trials rise, it becomes increasingly important to establish a quantitative means of estimating the appropriate staffing resource to coordinate trial related activities. There has been a limited amount of research conducted to evaluate methods or tools to measure workload in the clinical trial setting. A literature search revealed a gap in the literature about tools used to measure workload and its impact on clinical trial performance and job satisfaction. The aim of this pilot project was to test the Ontario Protocol Assessment Level (OPAL) complexity rating tool in generating quantitative measurements of workload for the purpose of assessing operational efficiencies and identifying opportunities for process improvement changes. The pilot project was conducted in a clinical trials unit consisting of clinical research nurses (CRN), clinical research coordinators (CRC) and research managers who participated in the project implementation. Concepts from the Institute for Healthcare Improvement (IHI) Model for Improvement and Plan-Do-Study-Act (PDSA) were used to guide project implementation and Lean principles for the interpretation of data findings. The findings from the data showed that OPAL can be used as a quantitative means to measure workload, and to assess factors affecting operational efficiencies.



Included in

Nursing Commons