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…

Over the past 20 years, there has been a significant increase in the number and complexity of clinical research studies. As a result, Clinical Research Professionals (CRPs), a workforce critical to the success of clinical research, have seen commensurate increases in workload and responsibilities. Unfortunately, there has not been a parallel…

Background: The peer review of clinical research projects is an essential step in project preparation. While some projects undergo rigorous review by grant-giving organizations, this does not apply to all clinical research. In many cases, peer review, if undertaken at all, is not rigorous, fully independent, or timely. Depending on their…

Japan's operating budget for its national universities has been reduced since 2004 year by year, leaving a tight competition among universities in securing research funding. Urban universities with several prominent researchers can operate by securing competitive funding, joint research with companies, and donations, whereas small rural…

A multi-centre clinical trial involves the implementation of the same clinical protocol at several independent investigational centres. Multi-centre clinical trials may be preferable to single-centre trials, but their implementation and management is more complex. EU-funded collaborative projects involve several participating organizations and…

The landscape of clinical research is continuously evolving, focusing now on the scientific assessment of efficacy balanced with patient safety, along with advancements in technology and informatics. These considerations necessitate the acquisition and retention of experienced staff that will be able to meet the demands associated with these new…

Employee performance is a critical factor in the success, or failure, of any organization. Therefore, it is paramount that the leadership and/or management team in an organization establishes and implements an approach that can effectively assess and evaluate the performance of its employees in an objective manner. Research administrators are…

Clinical trials must address a number of laws, regulations, and other sources of requirements when communicating privacy and confidentiality protections to potential participants. This article outlines relevant requirements from Common Rule regulations, Food and Drug Administration regulations, Health Insurance Portability and Accountability Act…

Background & Aims: Lean methodology is a continuous process improvement approach that is used to identify and eliminate unnecessary steps (or waste) in a process. It increases the likelihood that the highest level of value possible is provided to the end-user, or customer, in the form of the product delivered through that process. Lean…

Bridge-funding by tertiary-educational institutions allows researchers to continue their research in times of funding loss. With the ever-declining funding rates for major medical research institutions in North America, and the global economic downturn, it is crucial to critically assess institutional policies surrounding the allocation of…

The field of biomedical research has undergone several changes in recent years. These include increased funding, the rapid development in scientific knowledge which speeds up the obsolescence of equipment, facilities and knowledge and the growing complexity of scientific problems. Research administrators can take steps to address these changes…

The field of clinical research has changed considerably in the past 20 years. As the work in this realm has come to embody far more than the pursuit of improved patient care, this has meant that staff supporting the research are asked to take on additional responsibilities, learn new processes, and be continuously educated on modernized policies…

Academic careers and institutional reputations are closely linked with the ability to secure funding and publish work. In today's competitive environment, it is essential for research to be clearly communicated. In our experience, many researchers need assistance with communication skills, and institutions that offer professional services in…

Higher education institutions are often required to design and deliver a range of strategic academic programs in order to remain competitive, support growth and ensure operations are financially sustainable. Such programs may include the creation of new research centers and institutes as well as the installation of major new research facilities.…

Challenges that face the academic research enterprise are numerous. These concerns include, but are not limited to: declines in extramural funding for investigatorinitiated research, an aging faculty workforce (the average age of securing a faculty's first R01 is over 42), insufficient funds to support faculty laboratories, and limited access to…