MCCRSCC Risk Based Monitoring Solutions Question
You are a pharmaceutical project manager associated with a compound that is planned to have 4-5 co-occurring/overlapping trials of this compound. The success of these trials is extremely important and you are on the executive committee with the goal of overseeing and verifying these trials are set up with a focus on quality. Because of the tight timelines to get the compound ready for FDA submission, some of required trials will have to overlap (although minimally). As such, the monitoring of the trial is critical to the success of the compound overall. You propose instituting central monitoring (off-site monitoring that will feed in findings to the on-site monitoring team). You are proposing monthly calls with the central monitor so you can see the central monitoring team’s analytical information (negative deviational trend information with pre-set parameters such as data entry, protocol deviations, re-querying rate, SAE/AE rates per subject). Your job at this time is to propose this central monitoring (CM) approach to the other executive committee members.
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