A Journal of Postdoctoral Research.
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    ISSN : 2328-9791
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Risk Based Monitoring—Current Challenges with Implementation
Prajna Kumar, Jeroze Dalal, and Manoj P. Jadhav.
Multiple Universities across continents.
TexilaAmerican University, Guyana, Bombay College of Pharmacy, India, and College of Medicine, University of Florida, Gainesville, Flori
Background: The FDA issued guidance for the industry on the Oversight of Clinical Investigations-ARisk-Based Approach to Monitoring (RBM however the guidance lacks specificity on what successful implementations should look like and strategies that will address global adoption.

Purpose: To address current challenges with implementation of risk based approach to monitoring in the global research platform and suggest potential solutions.

Methods: Literature search was conducted followed by several discussion and brain storming sessions conducted to arrive at this brief write up.

Conclusions: Having a team science approach to implementation of the risk based approach to monitoring at the initial stage to ensure effective and efficient adoption across the industry in the global platform. This will eliminate inconsistencies in understanding as well as implementation of RBM by the investigational research sites.

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