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North Texas IRB Warning Letter (Site not responding. Last check: 2007-10-09) |
 | | IRB written procedures should describe how the IRB will review proposed research and continuing review of previously approved research when the only IRB physician member is not documented as present or there is no record of the physician’s vote, as occurred on November 11, 1997 and May 5, 1999. |
 | | The IRB failed to prepare and maintain minutes of the IRB meeting held on January 27, 1999, when the IRB discussed changes to study #8, and for the meeting held July 28, 1999, when the IRB discussed proposed changes to study #11. |
 | | The IRB records are inadequate to determine the dates that studies #l to #7, #9, and #I3 were closed. |
| www.fda.gov /foi/warning_letters/g3960d.htm (2011 words) |
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