The young woman who stepped into the aisle had an earnest vibrancy about her. She was engaged in a lively phone conversation that continued even while she arranged luggage in the overhead bin and took her seat next to me. Boarding an airplane was secondary to her exciting conversation. From what I could gather, she and some colleagues had resolved a major issue during their business trip. She had performed well and received special recognition from her employer.

Her exultation was contagious. It made me nostalgic for the early days of my monitoring career. I missed the excitement of accomplishing each milestone: being signed off to independently monitor a study on site, my first monitoring visit and my first significant finding during source document/care report form (CRF) review.   

From the moment I first set foot at an investigational site for a monitoring visit, I was hooked. The clinical research associate (CRA)  manager who trained me emphasized the true partnership of site management. There was an integral need for monitors to compliment and not criticize, to educate and not undermine and to work alongside and not apart from investigational site staff, for the benefit of the study. These ideals took root and were the foundation for each decision I made as a CRA.  

Once in the air, I retrieved my laptop. As it booted up, my company’s logo appeared on the home screen. My inquisitive seatmate recognized the company and asked if I was a CRA. I discovered that she was a new CRA assigned to a co-monitoring team on a large respiratory study. She had finished her initial coursework, and had been assigned to the co-monitoring effort as part of her probationary training. She and her CRA colleagues had spent the last four days at a large, high-enrolling pulmonary practice. Her meticulous review of source documents (I smiled at her choice of words) had resulted in several unreported deviations. She had successfully retrained the study coordinator and assisted with the deviation reporting process. Due to her positive performance, they had accelerated her training timeline. She was due to be signed off to conduct independent monitoring visits the following week.

I shared in her happiness. She was close to her first milestone. She had started a career journey that would literally change her life.

Her story reminded me of one of my most significant monitoring milestones. During my third year as a CRA, I had been assigned to a dedicated CRA team that monitored a pivotal oncology trial at an academic institution. We had to tread lightly as they were a high-enrolling institution led by an influential investigator. The protocol and Investigator’s Brochure (IB) had been amended to include (newly received) critical study drug safety information. All of our study sites had to rapidly revise the informed consent forms (ICF) due to the nature of the data.

This academic network was comprised of a main site and 30 network sites across the region. I was tasked to review the main site and network site consents for the updated drug safety information, and to confirm the patient re-consenting process was on track. In reconciling the main site and network site master ICF content, I discovered that they were not identical. The study drug safety information about increased bleeding risk had been correctly included in the main site ICF, but omitted from the network ICF. Unfortunately, the network ICF had been IRB approved and distributed to thirty network sites for the purpose of reconsenting patients.

This finding made me anxious as it was a significant protocol deviation. I needed to double-check my work to ensure I had found an error. I cross-referenced the amended protocol and IB with the main site master ICF. I then did a paragraph count of the additional data on both the main and network site ICFs. The main site ICF incorporated the safety information into four additional paragraphs. The network ICF only had three additional paragraphs. It was indeed missing the paragraph on increased bleeding risk. I immediately presented the finding to my lead CRA. The situation was delicate because it involved patient safety and key personnel. We had to educate staff and manage the deviation process, while preserving the relationship with the site. This was brand-new territory for me.

The lead CRA double-checked my review. After confirmation, he arranged a meeting with the site program manager and included me in the corrective and preventive (CAPA) discussion. Fortunately, the site took the finding very seriously. They started amending the network ICF to incorporate the missing safety information and had it ready for expedited IRB review in several days. It was distributed to the network sites within a week. There was appreciation from the site, as opposed to anger. We developed a stronger camaraderie in the resolution process as it required the efforts of site and monitoring staff working cohesively, not adversarially. It strengthened our relationship with the investigational site, which led to several more projects for our company. The lead CRA and program manager thanked me for bringing it to their attention.

As the plane taxied down the runway, I felt indebted to this young stranger who shared her enthusiasm for clinical research, reminding me of how exciting and important it is to be part of the drug discovery process.  

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 clinical research writer. Email ebwcra@yahoo.com.

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