Keyword Analysis & Research: monitoring definition fda


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Frequently Asked Questions

When did the risk component become part of drug monitoring decisions?

Firstly, after the publication of the FDA (August 2013) and EMA (November 2013) guidances the majority of pharmaceutical companies and service providers, started thinking about including the risk component in their monitoring decision-making.

What is the purpose of risk-based monitoring?

The purpose of risk-based monitoring is to help clinical research organizations predict and manage risk at an early stage, so that monitoring resources can be prioritized based on risk and need rather than the traditional 100% SDV approach.

What is the RBM from the FDA point of view?

Thus, inferring from the FDA guidance we get the first definition of the RbM from the FDA point of view: RbM – is the adequate mix of strategies including centralized and on-site monitoring practices with the goal of human subject protection and trial integrity.

What is the role of specialized personnel in a monitoring program?

Such specialized personnel may be assigned responsibility for day-to-day administration of the program, may carry out monitoring duties beyond the level of training of the staff technologist or, if desired by the facility, may relieve the staff technologists of some or all of their basic monitoring duties.


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