FDA mandatory Diversity Plan

[Debra Wells]

Hi – where are folks filing the mandatory FDA Diversity Plan? Is there a place in the TMF Ref Model established or planned?

Thanks as always!

[Eldin Rammell]

Hi Debra,

In general, the proposed Diversity Plans will not be trial-specific but will rather be plans across a product development program. On this basis, I suggest they would not be expected to be filed in the Trial Master File.

Were a trial-specific Diversity Plan to be created, my suggestion would be to file under 01.01.02 Trial Management Plan on the basis that its purpose is aligned with the definition/purpose of this artifact

or 03.01.01 Regulatory Submission on the basis that it is a trial-related document that is submitted to a regulatory agency (filed to the IND).

The draft guidance seems to suggest that its use will be recommended rather than mandatory, though it does sound as though the FDA are being pressurized to mandate its use.

Any thoughts from others?

Kind regards,
Eldin.

[Debra Wells]

Thanks, Eldin. Your opinion was in line with mine as well.

As an FYI, we are learning that this has been requested during inspections by FDA already, to some of the larger pharma.

Thanks again.

[Donna Dorozinsky]

Hi Debra and Eldin, I would agree. I think filing this with the Trial Mangement Plan makes sense. If you system allows you to file to multiple studies at one time, but might be a good option.
Kind regards,
Donna

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