ABSTRACT
Clinical trial management system is independently developed by our hospital, which basically realized the whole process management and data collection of clinical trials. Based on the platform, the functional architecture of data remote monitoring and auditing was established. By desensitizing and encrypting of data, the project and subject hologram were visualized to facilitate to review of data. The data remote monitoring and auditing cloud platform adopts the B/S architecture pattern. Users register to apply for an account through the cloud platform, and access to the account via HTTPS security protocol. The authorized users were able to view the relevant items online to ensure the secure data transmission and easy operating. The electronic management of data is the direction of future efforts. By compliance with laws and regulations, the remote monitoring/auditing can be realized, and the data security and personal privacy can be ensured with the application of information technology. In this paper, the feasibility of remote monitoring/auditing mode is explored, specific technical schemes and system functions are suggested, and the realization scenarios are conceived in case of major public health emergencies.
ABSTRACT
PURPOSE: In order to enhance the quality of IMRT as employed in Korea, we developed a remote monitoring system. The feasibility of the system was evaluated by conducting a pilot study. MATERIALS AND METHODS: The remote monitoring system consisted of a head and neck phantom and a user manual. The phantom contains a target and three OARs (organs at risk) that can be detected on CT images. TLD capsules were inserted at the center of the target and at the OARs. Two film slits for GafchromicEBT film were located on the axial and saggital planes. The user manual contained an IMRT planning guide and instructions for IMRT planning and the delivery process. After the manual and phantom were sent to four institutions, IMRT was planed and delivered. Predicted doses were compared with measured doses. Dose distribution along the two straight lines that intersected at the center of the axial film was measured and compared with the profiles predicted by the plan. RESULTS: The measurements at the target agreed with the predicted dose within a 3% deviation. Doses at the OARs that represented the thyroid glands showed larger deviations (minimum 3.3% and maximum 19.8%). The deviation at OARs that represented the spiral cord was 0.7~14.8%. The percentage of dose distributions that showed more than a 5% of deviation on the lines was 7~27% and 7~14% along the horizontal and vertical lines, respectively. CONCULSION: Remote monitoring of IMRT using the developed system was feasible. With remote monitoring, the deviation at the target is expected to be small while the deviation at the OARs can be very large. Therefore, a method that is able to investigate the cause of a large deviation needs to be developed. In addition, a more clinically relevant measure for the two-dimensional dose comparison and pass/fail criteria need to be further developed.