Here’s an extraordinary tale of investigator oversight and commitment.
When Dr. “Smith” emailed me to inform me his study coordinator had unexpectedly left the practice, I wasn’t concerned. The pre-study assessment visit was six weeks away. His personally informing me of the staffing change, however, was not an ordinary communication from an investigator. But nothing this doctor did was ordinary, which was the primary reason why I recommended him for our study.
I followed up with Dr. Smith about his study coordinator two weeks before our scheduled meeting. It wasn’t practical to conduct a pre-study assessment without key staff present. I had not yet received confirmation from the doctor regarding his replacement study coordinator. I would need to reschedule the pre-study assessment if he had not found a new coordinator.
Dr. Smith’s response, informing me that he had found one, was indicative of his professionalism. It demonstrated an understanding of reciprocal need. We both had visit requirements: His was to gain a clinical and logistical understanding of the study, to ensure he could meet those requirements; mine was to assess/verify that his investigational staff was trained/experienced, and his investigational site equipped and capable for study conduct.
Dr. Smith’s email confirmed we were on the same page about visit goals and vested in a process that required our collaboration and understanding for a mutually successful outcome. Dr. Smith was a well-known interventional cardiologist and on staff at a prestigious local university. I looked forward to meeting him.
About 10 minutes after my arrival at the site, I met a nurse, “Betty,” who I realized must be the new study coordinator; she was a ball of nervous energy. As I was about to ask about her research experience, Dr. Smith entered. His candor was disarming: “Betty has been my nurse for nine years. She is very experienced with this patient population. But she is new to research.”
Well, that answered my question. Research inexperience did not cause me undue concern, provided the investigator had an appropriate training plan for his staff. I waited, and he continued his explanation: “I am completing Betty’s research training. We have reviewed 21CFR and GCP guidelines, and the study protocol. We also are completing the startup regulatory documents together, to facilitate the learning process.”
There was nothing to contest; he was fulfilling his investigator responsibility for staff training. My subsequent discussion with Betty (to gather information on site experience and capabilities) would determine the learning curve. Her clinical workload, while learning her new position, would verify or invalidate the learning process.
Although the doctor’s training plan seemed sound, it required the right environment for execution. If Betty’s was packed with both nursing and research tasks, it would be nearly impossible for her to assimilate all required information. I had to determine if the coordinator’s commensurate clinical experience would facilitate understanding of the clinical research process.
The doctor excused himself, and Betty and I had an informative, one-on-one discussion. She described him as a kind employer and patient mentor. They were establishing research infrastructure to ensure consistency in research practice. Dr. Smith had Betty working part time for the practice while she learned her new position. He had only accepted two small studies (ours and another in startup) to ensure Betty could perform at a reasonable pace. Betty followed the discussion fairly well, with minimal clarification required. Dr. Smith had done a wonderful job of acclimating Betty so quickly.
Dr. Smith returned for the study design and eligibility discussion. To my surprise, he asked to explain study objectives and eligibility, as a training opportunity for Betty. I readily agreed. This served the dual purpose of affirming investigator study knowledge while completing study overview with the investigator and staff. And his explanation was unparalleled. As a therapeutic expert, he was able to simplify disease process and study rationale without undermining the main objective. It was a better way to explain protocol theory and intent.
The only thing left to confirm was the facility. Dr. Smith conducted the tour and again incorporated Betty’s training into the process. While showing me study drug storage, he explained to Betty the importance of adequate temperature monitoring. While showing me the lab, he described to Betty the processing and shipping of blood specimens. Throughout the assessment, he demonstrated oversight and due diligence.
At the assessment’s conclusion, I said I was recommending their site for the study. My only request was that Dr. Smith document all elements of Betty’s training; that would lend assurance to the sponsor and fulfill investigator training expectations. He readily agreed.
I left Dr. Smith’s site with stronger faith in investigator involvement. He demonstrated extraordinary commitment to the assessment process.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in clinical research roles. Currently she works in relationship development/study startup in the CRO industry. Email email@example.com.
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