Home » IRB’s Minutes, Inconsistencies Result in FDA Warning Letter
IRB’s Minutes, Inconsistencies Result in FDA Warning Letter
The FDA has warned Teneo, a Tulsa, Okla.-based IRB, for omitting serious adverse event reports and investigations from meeting minutes that it gave to an FDA inspector in March. The agency
discovered that violation and several other inconsistencies by comparing Teneo’s minutes with
another set of minutes from a redacted source, according to a Nov. 10 warning letter posted
recently to the FDA’s website. Teneo also failed to resolve inconsistencies on trial selection criteria for patients younger than 18 before approving
research, the letter says.
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