New Medical Monitoring and Safety Assumptions

Oracle ClearTrial 5.5 includes updates to existing medical monitoring and safety algorithms, including new, configurable assumptions used to calculate monitoring-related fees and costs accessible for late-stage studies, for users in Advanced/Expert mode.

All new assumptions/cost drivers will be displayed on associated out-of-the-box reports and accessible as a unit of measure to select from when creating user defined algorithms.

• Lab and Diagnostic Tests per subject, per treatment arm located on the Plan Treatment tab. This assumption's value is used to calculate the amount of time the medical monitor will spend reviewing lab and diagnostic test results.

• Cohort Escalation Reviews per treatment arm located on the Plan Treatment tab. This assumption's value is used to calculate the time required for the medical monitor and medical associate to determine appropriate changes in dosage.

• 24/7 Coverage for Medical Monitoring located on the Plan Monitoring tab. This assumption's value is used to increase the estimated time the medical monitor and medical associate will spend performing subject eligibility reviews, answering specific inclusion/exclusion criteria questions, and reviewing subject management and protocol issues that require medical judgment.

• Medical Data Listing Reviews located on the Plan Monitoring tab. This assumption's value is used to calculate the amount of time the medical monitor and medical associate will spend assessing point-to-point data, data across visits per subject, data across subjects per site, and data across the entire study.