Mastering The Monitoring Visit: Key Tips For Site Success

By Rachana Kanvinde, MS, SFC, CCRP

The ACRP Atlanta Chapter recently hosted a Lunch-n-Learn session on “Mastering the Monitoring Visit: Key Tips for Site Success.” The conversation highlighted the shared goal of CRAs and CRCs: ensuring compliance, protecting data integrity, and making monitoring visits a collaborative — not adversarial — experience.

Simply put, sites that maintain an “always-ready” state by keeping regulatory binders, source documents, and consent forms up to date experience smoother visits. Using checklists ahead of time minimizes last-minute stress and ensures nothing is overlooked, supporting the proactive quality-by-design approach emphasized in ICH E6(R3).

The Regulatory Backdrop

Unlike its predecessor, E6(R2), which focused heavily on monitoring and documentation, the draft R3 revision highlights “critical-to-quality factors” and proportional oversight. The goal is not to apply blanket processes across every aspect of a trial, but rather to concentrate resources on activities that directly affect participant safety and data reliability. In practice, this means a site doesn’t just prepare for a monitoring visit at the eleventh hour — it builds systems and workflows that prevent errors and ensure readiness every day.

For coordinators, checklists, dashboards, and structured SOPs aren’t simply administrative tools; they are practical ways to align with the R3 expectation of embedding quality into trial conduct from the start. Investigators, too, are expected to show continuous oversight, not just periodic sign-offs. When sites adopt these habits, monitoring visits shift from being stressful checkpoints to opportunities for improvement and collaboration.

This emphasis on proportional oversight is echoed by regulators globally. The FDA’s Guidance on risk-based monitoring encourages sponsors to move away from exhaustive review of every datapoint and instead target higher-risk activities. The EMA takes a similar stance in its reflection paper on risk-based quality management, stressing the need for proper risk identification and oversight that safeguards trial quality without creating unnecessary burden. Together, these positions reflect a regulatory evolution that is reshaping the monitoring landscape — moving it away from box-checking and toward risk prioritization, efficiency, and partnership.

Common Pitfalls and Emerging Solutions

During the Atlanta discussion, our members flagged familiar challenges: incomplete PI oversight, delays in data entry, and late query resolution. These issues aren’t unique to any one site — they appear frequently in FDA Form 483 observations and remain a top cause of frustration for sponsors. Unresolved queries, in particular, can ripple downstream, slowing database lock and delaying trial completion.

But, of course, there are always new tech solutions being touted. For example, many sites now use eReg systems, dashboards, and eSource tools to ensure documents are continuously reconciled and accessible. That means CRAs can review materials remotely, flag issues early, and spend on-site time working collaboratively with coordinators rather than chasing missing paperwork. This kind of proactive partnership is exactly what regulators envisioned when updating monitoring guidance. (For a deeper dive into how these practices are reshaping trials, see Clinical Leader’s article on synthetic control arms, which highlights how data-driven oversight is becoming central to modern trial management.)

The pandemic accelerated adoption of hybrid monitoring models, blending centralized data review with selective in-person visits. Going forward, AI and advanced analytics are expected to play a larger role in identifying anomalies or risk signals, allowing CRAs to focus their limited time where it matters most. Still, the fundamentals highlighted at our Atlanta session remain essential: preparation, proactive communication, and mutual respect between sites and sponsors.

The bigger picture is clear. Monitoring visits are not just checkpoints along a trial timeline. When approached with transparency and collaboration, they can become catalysts for stronger site–sponsor relationships, more efficient study execution, and ultimately safer, higher-quality outcomes for patients.

About The Author

Rachana Kanvinde is a certified clinical research professional with over two decades of experience advancing clinical operations, site network strategy, and research execution — with a specialized focus in rare disease, gene therapy, and pediatric trials. Throughout her career, she has led multi-site research networks, launched first-in-human studies, built high-performing teams, and designed scalable site operations tailored to the unique complexities of advanced therapeutics. A champion of operational innovation, Rachana is known for advancing site readiness through process standardization, workforce development pipelines, and patient-centric practices. As President of the ACRP Atlanta Chapter, she curates educational programming and fosters mentorship and community-building across the research workforce. Her mission is clear: to power purpose-driven clinical research that delivers equitable access and lasting hope to rare disease communities.