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Queen of the Valley Hospital.


Queen of the Valley Hospital, Napa, CA, June 7 (Office of Compliance). Deficiencies involving the hospital's institutional review board (IRB) included not following SOPs for initial and continuing review, reviewing research without a quorum, inadequate record retention, inappropriate use of expedited review and not adhering to procedures for prompt reporting to FDA and institutional officials. The agency acknowledged the hospital's response, but said it lacked supporting documentation and a schedule for corrective actions. BiMo

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Publication:Warning Letter Bulletin
Date:Aug 30, 1999
Words:74
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