IRB Quality Concerns Take Center Stage After FDA Clamps Down On Coast
Quality has moved up in importance as a criterion for selecting an institutional review board following an April 14 FDA warning letter to Coast IRB and the company's agreement to halt enrollment in clinical studies it monitors
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Joint draft guidance on institutional review board switching for industry- and federal government-sponsored clinical trials advances the agencies’ goal creating umbrella coverage in human subject protection.
In an operation highly reminiscent of a government sting three and a half years ago, "Dateline NBC" snares a for-profit IRB using a fictitious protocol.
The White House appears close to finalizing a policy that would allow multi-site clinical trials to use only one institutional review board, which National Cancer Institute and other officials think could speed up and improve the process.