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.

Must include :

10 points:  Introduction and conclusion, title page, APA style and references (at least 3).

10 points:  APA style including but not limited to cover page, running title, summary, page numbers.

Note: You must include an introduction and conclusion paragraph as well as a list of references in APA style and a minimum of 3 articles (from this class, FDA guidance or alternative).

Three (3) benefits (you would propose to the committee) of including CM (10 points each X3)

Two (2)  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)  (10 points each X 2)

Three (3) take away points  you would want the executive committee to consider in favor of the CM approach(10 points each X3)

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