IRB Handovers Harmonized In Eight-Fold Path Outlined By FDA, OHRP
This article was originally published in The Pink Sheet Daily
Joint draft guidance on institutional review board switching for industry- and federal government-sponsored clinical trials advances the agencies’ goal creating umbrella coverage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.
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Clinical trials that take place at multiple U.S. sites and are covered by the "Common Rule" of federal regulations relating to human subject protection could soon be required to use a single institutional review board of record, under a proposed revision.
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
Clinical trial investigators, not sponsors, should ensure medical care for trial subjects who experience research-related adverse events, a recently issued FDA draft guidance says