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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :Avoid common mistakes when dealing with IRB/IEC.. 2009-10-26 18:26:01 
M.Anusha
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Joined: 2009-07-29 10:23:16
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"Many investigators are used to getting critiques and criticisms through peer review from federal grants, and if they could see the IRB/EC review as a similar mechanism of improvement of the science and protections of human subjects, then they could come out with stronger protocols and change their attitude.

Tips on how to improve investigator-IRB relations:

-join the local IRB/EC;
-address all points IRB/EC raises in response to review;
-provide literature citations when indicated;
-request previews judiciously;
-respect the IRB/EC office's workflow issues.

Regards
Anusha
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