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Wednesday, May 10, 2023 | 4:47 PM
Ensuring adherence to protocols remains a critical aspect of conducting successful trials. It is crucial to ensure that the study procedures are followed so that the rights and safety of participants are protected and that the data is accurate. In fact, adhering to study protocols can make deviations an avoidable part of the clinical trial process.
With that said, sponsors and CROs can and should take a more proactive approach to reduce these deviations. Protocol deviations can be prevented by providing adequate training to site personnel to perform research activities or duties on patients. Site training systems can help with this by providing study teams visibility into the frequency of deviations. At the first hint of increasing deviations, a sponsor or CRO can redefine their training strategy and assign additional training to researchers at a site before deviations spiral out of control.
This is not the only way in which choosing the right LMS for site training can help benefit a study. The ideal learning management system will have the right capabilities to give your study teams insight into the context of site re-training events—this is typically an indication of site performance problems. Ultimately, this helps reduce low quality and inefficiencies in a clinical trial. If study teams are serious about improving clinical site operations, ensuring the downstream quality & efficiency of a clinical study, and becoming inspection ready, an efficient training system is a must-have.
Becoming inspection-ready is not only about mitigating compliance risks like protocol deviations—it also means streamlining processes as much as possible. An effective site training tool will not only save time by automatically sending training certificates to the eTMF but also decrease the capacity for human error, avoiding events like duplicate uploads or missed certificates.
Clinical trials are highly regulated, and documentation is a critical component of ensuring compliance and readiness for inspections. However, managing documentation can be time-consuming and error-prone, especially when it comes to training certificates. Many sponsors and CROs rely on study staff, such as CRAs, to upload training certificates into eTMFs or eISFs manually. This process can be tedious and takes valuable time away from more strategic activities. Moreover, it is prone to human error, resulting in duplicated or missed certificates that could cause issues during inspections.
An effective site training tool can make this process much more efficient by automatically sending training certificates to the eTMF. This approach not only saves time but also reduces the potential for errors. Looking a little more closely at the documentation paints a clear picture of ROI in terms of administrative savings.
Let's consider a hypothetical Phase III study with 100 global sites, each with 10 site staff. To calculate the cost savings of using an LMS with automatic certificate upload functionality, we need to estimate the amount of time that would be saved by automating the upload process.
Based on our assumptions, each certificate takes approximately 30 minutes to upload manually. Therefore, across all sites and all personnel, the estimated time required for manual certificate upload is 2,500 hours (100 sites x 10 personnel per site x 5 courses per personnel x 0.5 hours per certificate).
If an LMS with automatic certificate upload functionality were used instead, the estimated time required for certificate upload would be zero. Therefore, the time savings would be 2,500 hours.
To convert the time savings into cost savings, we need to multiply the total hours saved by the hourly rate of the CRA, which is $80 per hour according to our assumptions.
2,500 hours x $80 per hour = $200,000 in cost savings. Therefore, by using an LMS with automatic certificate upload functionality, we can potentially save $200,000 worth of CRA time—a significant ROI for the sponsor or CRO. Moreover, the reduction in human error could also save time and resources associated with correcting mistakes, mitigating compliance risks, and responding to regulatory inquiries.
In conclusion, an LMS with automatic certificate upload functionality offers a significant return by saving time and reducing the potential for errors in clinical trial documentation management. By investing in such a tool, sponsors and CROs can improve compliance, streamline operations, and ultimately improve the efficiency and success of clinical trials.