If You Need an Apple, Get an Apple
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If an investigative site is to grow successfully, specific functions of the clinical trials process must first be solidly
in place. A common pitfall in this industry is for the owner or Director of Business Development of a young site to promote
itself before it can adequately perform more studies. This happens when site management has not yet recognized the critical
importance of developing the appropriate infrastructure needed to support a site aiming to grow its clinical trials business
carefully and thoughtfully. There are basic elements (Figure 1) needed to build a firm foundation for growth with quality,
and while a detailed discussion of each of these functions is beyond the scope of this article, a few are highlighted.
Director of Clinical Operations (DCO) The Director of Clinical Operations (DCO) is crucial to site growth and, assuming the right person is hired, will be instrumental
in moving the site to the next level. The DCO oversees all of the day-to-day clinical operations. He or she meets weekly with
all study coordinators; assigns studies to the study coordinators based on their experience and current workload; participates
in all study initiations, close-out meetings, monitor visits, Food and Drug Administration (FDA) and sponsor audits; meets
with the quality assurance team to discuss trends and issues; acts as a liaison between the sponsor, investigator, and study
coordinator to address issues relating to protocol compliance; oversees formal staff training on many topics, including HIPAA;
and is involved in any clinically-related issue with regard to budgeting, contracting, and salary reviews. The DCO is the
glue that holds the site together. All study coordinators, research assistants, regulatory staff, and laboratory personnel
report to the DCO, who in turn, reports directly to the primary investigator and the CEO.
Figure 1. Key Elements for a Successful Site
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The ideal candidate is someone who has had site experience, is familiar with good clinical practice standards, and has a clinical
background, such as a nurse who has worked in an ICU or in some other type of nursing environment with rigid, military-like
rules and constraints. Hiring someone with this kind of background will increase the likelihood that the individual can function
in a highly structured, regulated workplace. The DCO should also have management and leadership skills. Previous experience
as a monitor is desirable, but it is strongly preferred that the DCO have site experience as a study coordinator, or as some
other site-based clinical professional (see sidebar "If You Need an Apple, Get an Apple").
Quality assurance The growing site needs to establish a quality assurance (QA) department, even if that department starts with nothing more
than a single full-time equivalent (FTE), or a partial FTE, depending upon workload. A number of site alliances and site management
organizations (SMOs) share one quality assurance FTE who travels from site to site, to QA the charts prior to monitor visits.
Sponsors, CROs, and monitors recognize and appreciate this investment in quality. 
Figure 2. Key Responsibilities of the Quality Assurance Department.
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The purpose of the QA department is to develop and implement programs designed to improve the quality of studies conducted
at the site,1 starting from day one. This raises the bar for patient safety, and should enhance outcomes of monitoring visits.
