Quality assurance of clinical data: diagnostic standardization.
Diagnostic standardization requires substantial effort, including detailed specification of procedures in a written protocol and training of examiners in such procedures. Success is neither automatic nor assured. It is essential to monitor performance through replicate examinations and/or computation of examiner variance. When examiner variance exceeds permissible limits, consideration should be given to discarding the data.
D002986:Clinical Trials as Topic; D003933:Diagnosis / Q000592:standards*; D004812:Epidemiologic Methods; D005069:Evaluation Studies as Topic / Q000379:methods / Q000592:standards*; D005128:Eye Diseases / Q000175:diagnosis* / Q000453:epidemiology; D006801:Humans; D011786:Quality Control; D012108:Research Personnel; D012306:Risk