To initiate clinical research studies successfully and efficiently, it is critical to develop a strong, feasible, and well-written study protocol early in the start-up phase. The University of Minnesota’s Clinical Research Support Center designed and implemented a structured Feasibility Review process in 2018 that addresses common start-up challenges such as poor study design, inappropriate outcomes, and limited resources. This process has been shown to turn an unfeasible study into a well-designed protocol that is IRB-approved with few protocol-related stipulations and well prepared for execution. It has also educated study teams on how to write better-quality and more robust protocols for subsequent studies. Once a draft protocol is available, the entire process takes just six working days and is free of charge to investigators, study teams, and departments. From 2018-2021, one hundred sixteen Feasibility Reviews (n=116) have been completed across eight schools or colleges. Mean satisfaction scores for study team members who responded were high (N=126, M=4.71 ± 0.5) on a 5-point Likert-type scale. Most respondents (96%) indicated that they planned to modify their protocol based on reviewer feedback. Open ended/ qualitative feedback was highly positive with most responses centered around the helpfulness of feasibility review, the high level of expertise, and fast turnaround time. The Feasibility Review is a valuable and multifunctional program providing timely expert guidance to study teams to efficiently and successfully launch and execute clinical research studies. It can be easily replicated, adapted, and implemented at other institutions to increase the quality and efficacy of academic research.
|Original language||English (US)|
|Number of pages||16|
|Journal||Journal of Research Administration|
|State||Published - 2022|
Bibliographical noteFunding Information:
Support for this project was provided by the National Center for Advancing Translational Sciences of the National Institutes of Health (UL1TR000114). The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This project did not meet the criteria to be considered Human Subjects Research according to the IRB definition of human subjects.
© 2022, Society of Research Administrators International. All rights reserved.
- clinical and translational science
- feasibility review
- protocol development
- study start-up