The Case at Hand: Protocol Deviation Uncovered

During an in-process monitoring visit, the monitor observed that a subject arrived two hours late for a scheduled dosing Day 5. While this deviation was noted during the monitoring visit, a subsequent review of site documentation revealed, no record of the deviation nor was any protocol deviation reported. The documentation inaccurately recorded the dosing time as if it adhered to the protocol schedule, raises concerns about data integrity and protocol compliance. All Sampling time points are wrongly captured and concentration are not related to actual sample collection time. Which reflects the wrong data interpretation and ultimately failure of study objective. This incident highlights the importance of vigilant, real-time monitoring to catch and address discrepancies promptly, ensuring subject safety and trial reliability.

Why In-Process Monitoring Matters

• Ensuring Real-Time Compliance

  In-process monitoring acts as a safeguard, ensuring sites adhere to protocol requirements and Good Clinical Practice (GCP) standards. In this case, timely intervention by the monitor allowed for:

  • Verification of dosing and identification of documentation gaps.
  • Immediate escalation of the issue to the sponsor and Principal Investigator (PI).

  Without in-process monitoring, such deviations could compromise the trial’s validity.

• Mitigating Risks

  Protocol deviations, if unaddressed, can jeopardize subject safety and data reliability. In this case, the deviation was promptly reported, corrective measures were implemented, and subject safety was upheld. Monitoring helps prevent minor issues from escalating into major non-compliances.

• Strengthening Documentation Integrity
  

  Accurate documentation is the backbone of clinical research. The monitor’s efforts led to the retrospective reporting of the protocol deviation, updated source documents, and the creation of a checklist to ensure real-time documentation moving forward.

•  Driving Continuous Improvement
  

  By identifying gaps and providing actionable feedback, monitoring fosters a culture of continuous improvement. In this case, site staff received targeted training on GCP principles and protocol adherence, reducing the likelihood of similar incidents.

Zenovel’s Approach to In-Process Monitoring

At Zenovel, we are committed to delivering excellence in clinical trial oversight. Our comprehensive in-process monitoring services focus on:

• Proactive Issue Detection: Identifying deviations and deficiencies early to prevent trial disruptions.
• Real-Time Communication: Establishing clear protocols for escalation to sponsors and stakeholders.
• CAPA Implementation: Guiding sites through corrective and preventive actions to ensure compliance.

Our monitors are equipped with the expertise to address challenges swiftly and effectively, safeguarding trial integrity at every stage.

Conclusion

In-process monitoring is not just a regulatory requirement—it is a critical component of clinical trial success. By ensuring compliance, protecting subject safety, and maintaining data integrity, monitoring safeguards the credibility of clinical research.

At Zenovel, we leverage our expertise in clinical research and GCP monitoring to deliver robust oversight solutions tailored to the unique needs of each trial. Together, we build a foundation of trust and excellence in pharmaceutical innovation.

Ready to elevate the quality of your clinical trials? Partner with Zenovel for unparalleled monitoring and compliance support.