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Documentation of the process and use of control data that a laboratory employs to consistently and reproducibly report results that are reliable; may include but is not limited to reporting of calibration and control results for a research test parameter, antibody or pharmacokinetic testing that may be performed by an internal or external laboratory. Bioanalytical Validation Method documentation is required if certification or accreditation is not available for the study test method. [Adapted from TMF-RM]
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