Think about how you would conduct Risk Based Monitoring (RBM) for the DTCC-1200 trial. Remember, RBM requires the identification of risks that may impact human subject safety or the scientific integrity of a study. What are some of the risks that a monitor may track as part of this protocol? Your assignment is to identify 4 risks that you would monitor as part of a RBM plan for DTCC-1200. For each risk, you should: List the risk category (Choose from these categories: safety, essential documents, data quality, investigational product, subject-level issues participation, site-level issues, staffing/supplies, issue management) Identify a critical data point or process associated with that risk Specify the risk indicator you would use to measure the risk Specify the threshold that you would use to take action Categorize the risk priority: (High, medium, or low) and why you classified it that way See slides 16-19 of the lecture for examples. Remember that these risks should be specific to the DTCC-1200 protocol