The monitoring visit report serves a spectrum of integral purposes specific to each monitoring visit type. It is the medium by which all findings identified at monitoring visits, and the status of findings from previous monitoring visits, are documented. It provides conceptual proof of training delivery for initiation visit conduct, and a logistical, clinical and developmental summary recommendation of the investigational site following the pre-study assessment. The closeout visit report signifies closure of investigational sites with submission and signature. The monitoring visit report is the full confirmation of monitoring processes at investigational sites.
With the monitoring visit report creation/submission process, minimal detail undermines the importance in capturing the “site story,” which includes the critical narrative of subject safety, data collection and GCP issues. Alternatively, the quality of content drives the resolution of issues and reduces the need for corrective and preventative action (CAPA).
The monitoring report provides an opportunity for the CRA to demonstrate monitoring proficiency, due diligence and appropriate site management. Accurate content is integral to perpetuating this dialogue. A comprehensive monitoring report differentiates a mediocre from a conscientious monitor. It validates the efforts of previous CRAs, and guides those that follow through the investigational site process to successful site management.
There are few things more important than data collection in clinical research; inaccurate and credible data both have a far-reaching impact on trial outcomes.
When I first started monitoring, I was eager to develop strong partnerships with the sites to which I had been assigned. My biggest mistake was in assuming they were as eager as I had been to develop the relationship. On a fairly complicated genito-urinary study, the sites had been without a monitor for several months. It was no surprise that the circumstances had rendered them listless and unmotivated. The previous monitoring visit reports were bereft of any pivotal indicators of true status except for the data backlog. I was ignorant of the negative relationship dynamic between the sites and the assortment of monitors that had preceded me.
When I arrived at the investigational site, I was escorted to a small monitoring area. The research team was conspicuously absent. A large pile of patient folders and corresponding CRFs were arranged haphazardly on a large desk. Nonplussed, I powered up my computer, organized my monitoring tools and opened the first casebook. I was greeted by a large, neon green sticky note affixed to the inside cover, with the words “MONITOR DU JOUR, PLEASE ADVISE” in bold, black caps. This was my introduction to the unfortunate state of this particular relationship.
The entire casebook was empty, though the patient had been in the study for several weeks. No one guided the site through the screening and randomization documentation. I held the sticky note thoughtfully; that message was received as clearly as the purposeful absence of the research team. A slew of temporary CRAs had barely made a dent in the case load review. They were not vested in site success, as demonstrated by the lack of progress before me. Without an assigned monitor to work with them, the site had understandably “checked out.”
Without accurate monitoring reports to guide me, I had no knowledge of the true status quo. I went to the front desk and requested a meeting with the study coordinator. It was up to me to encourage my new site and reassure them that I would be there for the long haul.
Recently, I was assigned to assess sites for a neurology trial. It was a sister study to a currently enrolling trial with the same compound, and many of the investigational sites qualified for a phone assessment, because they had monitoring visits within the last year. I was provided the prior monitoring visit report for the investigational sites I was to qualify, to confirm there had been no changes since the last on-site monitoring visit.
A bright and detailed colleague had conducted the prior on-site monitoring visits for several sites I was assigned to. Her monitoring reports detailed the site staffing, equipment, licensure and enrollment chronology and provided a detailed status to the confirming CRA. Several days before a phone evaluation, I was reviewing the previous monitoring visit report and noted a particular finding by my colleague that stated the investigational site was moving location by year’s end. The new facilities required physical confirmation, which disqualified the site for the telephone pre-study assessment. The finding had been listed by my colleague as an outstanding issue that required resolution by the next monitoring visit. If she had not been so diligent in her reporting, I may have missed this critical detail. Her actions prevented incorrect visit conduct and saved invaluable time and resources. We were able to schedule an on-site visit in a reasonable timeframe, which pleased the sponsor.
The monitoring report is the final insight to site operations and communication. The monitor assuming or continuing site management relies on truth in content to perpetuate truth in communication.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, currently works in relationship development/study startup in the CRO industry. Email firstname.lastname@example.org
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