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FDA Calculates Burden Of Producing Clinical Trial Monitoring Plans

 
• By Brenda Sandburg

The agency estimates that 88 sponsors will develop approximately 132 monitoring plans annually, as recommended in FDA’s draft guidance on oversight of clinical investigations; CDER will not be conducting prospective reviews of these plans but may do a pilot program in the future.

FDA has come up with an estimate of the burden of creating monitoring plans as called for in its draft guidance on the oversight of clinical investigations, which recommends that sponsors develop a prospective, detailed plan that describes the monitoring methods, responsibilities and requirements for each clinical trial.

The agency expects that 88 sponsors will develop approximately 132 comprehensive monitoring plans annually and that it will take approximately four hours to develop each plan, including the time for...

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