Descriptive Recording and Reporting of Ophthalmologic Examination Findings in Nonclinical Toxicity Studies

Abstract

In ophthalmologic examinations of nonclinical toxicity studies, descriptive recordings are required in order to objectively explain the characterization of findings to Study Directors, Project Managers, Sponsors of contracted studies, and Reviewers in governmental agencies. Appropriate descriptive recordings are useful when considering the anatomical and/or pathophysiological mechanisms of ocular findings. A descriptive recording commonly consists of terms used to record "Findings", "Tissue", "Location", "Number", "Shape", "Color", "Size", "Severities" and others. Each facility should prepare a glossary and/or dictionary for ocular terms, and should have their own standardized definitions. In the near future, submission of electronic data will be expected to be mandatory for new drug applications, and then, descriptive recordings in ophthalmologic examinations will be considered more important.