Clinical Researcher—August 2019 (Volume 33, Issue 7)
Elizabeth Weeks-Rowe, LVN, CCRA
As children growing up, we are taught to never judge a book by its cover, but to look within for the true character of a person. As researchers, we are taught to gather and analyze data before forming our ultimate hypotheses. This sage guidance is integral to site and investigator evaluation/selection, and should be included in every clinical research associate (CRA) training curriculum on the topic.
Don’t judge a site by its “cover.” Don’t let a superficial first impression influence your final opinion of site selection. Conduct a comprehensive evaluation visit that considers all site elements beyond brick/mortar and site location. This will ensure a fair, accurate process.
The Eye of the Beholder
There is no perfect site and any pursuit (of such) is fruitless. There is, however, an abundance of good sites possibly overlooked due to unfortunate factors of geography, physical presentation, and other details—for all the wrong reasons.
A site may not be in the best neighborhood or the most attractive building. Perhaps the area leases are priced unreasonably, and they must opt for what is affordable for the opportunity to conduct clinical trials. Sparkling equipment and architectural design do not guarantee credible research, but could disguise quality issues. The outer appearance does not speak to competencies of the staff within.
Even world-renowned health organizations, with presumed excellence, may rest on laurels long undeserved. Your most successful site may be in an inconsequential strip mall, in a semi-run-down neighborhood, and overlooked because the researcher neglected to take a second look.
Measure Twice, Strike Once
Several years ago, a remarkable site director reminded me of the importance of confirming the true character of a site before making the final selection recommendation.
I was tasked to evaluate a research site in the Southeast. The scheduling and visit confirmation had been a seamless process of responsive communication with an enthusiastic site director. I was looking forward to a productive visit with an experienced investigational site.
As I arrived at the site, I took note of the location. An ordinary strip mall, in a less-than-desirable neighborhood, flanked by a medical equipment retailer and an empty leasing office. Hardly a burgeoning medical center, but I banished any misgivings and entered the lobby. The initial presentation could mean nothing, or speak volumes, and it was my task to make that determination at the end of the evaluation.
The lobby was sparsely decorated, but extremely clean; sparking linoleum floor, not a speck of dirt in site. A cheerful receptionist announced my presence as I checked e-mail and waited for the site director to appear. Moments later, a professional-looking gentleman entered the lobby and extended his hand in greeting. He thanked for coming to their site as he escorted me past several rooms to his office in the back of the clinic.
The director explained that he shared space with the site’s sub-investigator, a family practice physician, and though it was a small space, they certainly utilized it efficiently. The director’s office stored regulatory binders and lab kits on separately labeled shelves. A small floor filing cabinet held documentation on all of the current employees’ training certifications, which he presented for my review.
Two small rooms comprised the site’s research department; one research exam room for study equipment and assessments and a larger open space that served the dual function of lab area/investigational product storage, and staff work area. The equipment was basic, and old, but still functioned well enough to provide compliant blood pressure, ECG, and spirometry results. The equipment calibration logs reflected consistency and meticulously listed the current date and manufacturer details.
The research staff retention was high and turnover was low—two important details when considering investigational site stability. The smiling faces of hardworking employees bespoke a positive work environment more important than physical presentation.
Behind the Curtain
The director informed me that the site’s principal investigator (PI), though newer to the role, had completed online investigator and Good Clinical Practice training, and had strong sub-investigator experience. While he had only served as the PI on two previous studies, his CV demonstrated his therapeutic expertise. The site had also arranged for the sub-investigator, an experienced investigator in his own right, to guide the PI through the first screening visit of each study for which he had oversight. Their due diligence spoke to quality in clinical trials conduct.
The visit concluded with the PI study discussion, and I was duly impressed with the insightful protocol questions that lent credibility to the site’s understanding of the study design. As I walked to the lobby with the site director, his parting words solidified my decision to recommend the site for selection. He did not ask the typical “What do you think?” or “Are you going to select us?” questions that would have left me feeling uncomfortable. He merely encouraged me to contact him with any additional questions or information required and thanked me sincerely for my time.
What didn’t stick in my mind as I left was the site’s location/physical appearance. What resonated with me was the high levels of professionalism, transparency, and preparation evidenced by the site director for the evaluation visit. The true site character showed a site with high potential that I would gladly recommend for our study.
Elizabeth Weeks-Rowe, LVN, CCRA, (firstname.lastname@example.org) has worked in clinical research for 19 years and is currently working for a contract research organization in a site engagement and education role. She last wrote for Clinical Researcher in April 2019’s “Taking the First Steps on the Path to Being a PI.”