Assignment: Risk Based Monitoring, Central Monitoring And Analytics Paper
Paper Scenario:
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, requerying 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.
Three benefits (you would propose to the committee) of including CM
Two robust ways to mitigate the risk of a site trending negatively (1. per the CM report; 2. you can take any liberties you would like on what trend scores were trending negatively. For example, data entry time, # of deviations, number of queries or query reissuing).
Three take away points you would want the executive committee to consider in favor of the CM approach.
Format your assignment according to the following formatting requirements:
1. The answer should be typed, double spaced, using Times New Roman font (size 12), with one-inch margins on all sides.
2. The response also include a cover page containing the title of the assignment, the student's name, the course title, and the date. The cover page is not included in the required page length.
3. Also Include a reference page. The Citations and references should follow APA format. The reference page is not included in the required page length.