Best practices for timely corrective action
Fourteen years ago as a new study coordinator, I was struggling to understand the responsibilities of managing several clinical trials.
One of my monitors took me under her wing and not only trained me in best research practice, but ultimately helped me obtain my first monitoring position. One year later, she became my first CRA manager. We always have had a successful partnership; she had a strong impact on my research career and remains a close friend and mentor to this day.
As a new monitor, one of the first studies to which I was assigned was a pivotal, phase III sinus trial. Though highly motivated, I still had much to learn. Fortunately, I was assigned to a large number of experienced investigators/staff who literally taught by example. I would pore over meticulously crafted source documents, closely examine detailed patient examination notes and memorize the order and content of their medical records to learn my craft and understand the correct way to document and record data. I attribute a rapid and comprehensive assimilation of research best practices to this group of sites. Their adherence to the highest clinical research standards was the perfect learning syllabus for a new CRA.
One investigator in particular strongly affected my perception of investigative sites and the importance of the CRA as site partner rather than site auditor.
Dr. “Smith” was very involved with his research patients and met the highest standard of investigator oversight: he was conscientious, compassionate and compliant. He created all of the research SOPs that managed his clinical practice. He trained new study staff in research process and procedures. He consented every study patient. He provided an hour of his time at each monitoring visit and was an attentive and engaged participant in each discussion regarding visit findings. With him I was able to witness an investigator take swift and corrective action to rectify a potentially large problem.
During a busy interim analysis, my CRA manager volunteered to co-monitor with me at Dr. Smith’s site. She had transitioned the site to me when she was promoted to a management position and so was very familiar with its source document/records management process. I was thankful for the help, as our data deadline was excruciating and Dr. Smith’s site had enrolled over 20 patients. Sinus CTs contributed to the main study endpoint and overall patient response to the study drug. We were, therefore, collecting redacted copies of each radiology report to accompany the CRFs in house for the data sweep. During patient review, my manager noticed several CT reports missing from the last two patients enrolled in the study. It was Thursday morning, and our absolute final CRF submission deadline was Friday at 5 p.m.—we had to have all 20 case books pulled, processed and ready for delivery by 4:55 p.m. Things had been going fairly smoothly until this point. We reviewed all 20 case books and source folders for any trace of the reports. After a futile search, we informed the study nurse.
Though the study patients’ CT scans were completed and interpreted by the radiologist, the radiology office had neglected to send the printed CT report for the records. It would be impossible to obtain the printed reports from the radiology office on such short notice. I was starting to panic—not meeting the interim analysis deadline was not an option.
My CRA manager and I decided our best course of action was to ask Dr. Smith for his help in obtaining the CT reports. We informed him of the problem, and he was extremely apologetic and sympathetic. He immediately called the radiology office. The reports were ready for retrieval that afternoon, and we completed each patient’s case book review by our deadline. Dr. Smith acknowledged the oversight, took responsibility as Principal Investigator and helped us resolve the issue and meet our data deliverable.
Over the last 10 years, I have had the pleasure of conducting several site selection teleconferences with Dr. Smith and his staff. Several months ago, I returned to the site for the first time in 14 years to conduct an assessment visit. When I met with Dr. Smith, it was as if time stood still. He may have had new research staff and a different office set up, but he was still the same courteous, attentive investigator, engaged in the conduct of safe and ethical clinical research. Investigators like Dr. Smith helped me become a better monitor.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and business development director. She has written and edited newsletters for several CROs, created training curriculum for CRA/clinical research educational and training programs and is a contributing writer to several research publications. She currently works in relationship development/study startup in the CRO industry.
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