There are three main types of clinical monitoring including on-site, remote, and centralized. Remote and centralized monitoring are often confusing since they are both conducted away from the site of the clinical trial. On-site monitoring, on the other hand, involves an in-person evaluation carried out at the site.
Purpose of On-Site Clinical Trial Monitoring
With the latest digitization and technological advancements, more of the monitoring processes can be facilitated remotely. However, when risk-based quality management involves regulatory focus on-site monitoring provides an undeniable value to a clinical study. Monitoring provides three purposes:
· Protect the rights and well-being of human subjects
· Compliance with protocols and applicable regulatory requirements
· Verify the accuracy and completeness of the data
On-site clinical trial monitoring helps achieve these three goals and provides validation which is valuable to future clinical research.
Advantages of On-Site Clinical Trial Monitoring
Build Relationships with the On-Site Study Team
Even though it may seem like a small thing, there are huge benefits to the two stakeholders (study team and monitors) who build a relationship. The monitor essentially works as a mediator between companies and the study team. The monitor often mediates questions and answers between the sponsor and the site. Therefore, the monitor offers a lot of support to the trial. When a successful relationship is forged, the monitor is able to detect and resolve issues at early stages. Ideally, the monitor and site will experience close collaboration.
Checking for Data and Knowledge Accuracy
Technology presents a wide range of options when it comes to remote monitoring. Some elements such as accuracy, compliance, and quality can be checked remotely. But the presence of a monitor on the site is necessary for some trials. Some examples where remote monitoring is not adequate include:
· Source Data Verification (SDV) – Due to measures used to protect patient information, some files may not be accessed remotely.
· Handling Investigational Medicinal Product (IMP) – In most instances, proper handling of the IMP (storage, distribution, shipping, destruction) needs strict surveillance on-site.
· Patient Information & Informed Consent – To ensure patient safety and accordance with regulations, the entire process of informed consent should be followed.
· Patient Enrollment – A monitor helps ensure that subjects included in the trial meet the inclusion or exclusion criteria. An on-site monitor can check paper and electronic records to ensure compliance with the eligibility criteria.
· Adverse Event Reporting – Monitors can assure that no adverse events are missing or unreported.
· Investigator Site File (ISF) – Site monitors ensure continuous traceability over the course of the trial and check all essential documents for completeness and solidity.
· Case Familiarity – The study team must have great working knowledge and understanding of the trial in order to ensure compliance with the protocol, patient safety, and data integrity. Direct contact between the monitor and study team ensures proper study conduct through implemented processes and procedures.
Immediate Reaction and Solutions
On-site monitors can mean immediate actions and quick solutions to any problems or issues that occur. This encourages staff to effectively optimize their processes and closely collaborate with on-site monitors to ensure a smooth study.
Final Thoughts
Perhaps there is not one single monitoring approach that works best for every type of clinical study or study setting. Monitoring strategies may need to be adapted and planned by taking account of the characteristics and potential risks specific to each study. Of the different types of clinical trial monitoring, on-site monitors offer hands-on, real-time monitoring that is effective and efficient.
References:
https://www.lexitas.com/wp-content/uploads/sites/6/2017/10/The-Hidden-Value-of-Onsite-Monitoring.pdf
https://globalhealthtrials.tghn.org/articles/clinical-trial-monitoring/
https://www.fda.gov/media/116754/download
https://cheos.ubc.ca/research-in-action/clinical-trial-monitoring-101/
https://khpcto.co.uk/SOPs/03_MonitoringSOP.php
