SECTION 310:15-3-2. Physician reporting

Latest version.

(a)   Any physician approved by the Commissioner of Health or designee to perform a clinical trial, pursuant to this Chapter shall submit annual reports, and a final report, to the Commissioner of Health. The report shall include:
(1)   Data from the clinical trial; and
(2)   Summary of findings from the clinical trial.
(b)   Any physician, approved by the Commissioner of Health or designee to perform a clinical trial pursuant to this Chapter shall immediately report to the Commissioner of Health and to the Director of the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control any adverse outcomes or injuries to any subjects participating in the clinical trial.

[Source: Added at 33 Ok Reg 451, eff 1-13-16 (emergency); Added at 33 Ok Reg 1519, eff 9-11-16]

                    
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