Clinical Study Conduct/Procedures

Abstract

In order for a clinical trial to be successful, meaningful, precise, and pertinent data must be collected so that the analyses of the clinical program will produce meaningful results. Such data collection begins with well-designed case report forms. This paper outlines what types of data should be collected. While efficacy is essential, other areas to be assessed include: adverse events, concomitant medications, dosages, and lab assessments. A checklist for designing an effective case report form is provided.