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Saint John's Health System.(BIMO/NIDPOE/ORI/OHRP)
- Article from:
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Warning Letter Bulletin
- Article date:
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June 1, 2008
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Anderson, IN, April 28 (OHRP)
In a September 14 letter OHRP found that the suspension of institutional review board (IRB) approval for Radiation Therapy Oncology Group (RTOG) 0615, which was documented in the June 13 IRB meeting minutes, was not reported to appropriate institutional officials, OHRP or the head of the sponsoring federal department or agency as required.
The agency acknowledged receipt of a Saint John's Health System Policy and Procedure entitled' Interactions with Institutional Review Board." The agency determined that this policy adequately addressed the finding noted above. In specific, OHRP determined ...