The Pyramid Concept

Abstract

Clinical Study Reports (CSR) have been organized into five levels of detail which form a pyramid. The peak is a one-page synopsis (Level 1) and the base is composed of case reports (Level 5). The second level is a brief summary written in the form of a manuscript as for publication, while the fourth level is composed of computer listings, study documentation, special analyses, and so on. The core, or third level, is a comprehensive summary which can stand alone without Levels 4 and 5. This organization permits us to meet the needs of regulatory agencies on a worldwide basis and allows reviewers to select the level of detail necessary for their specific requirements. The concept also has been applied to the preparation of a Marketing Authorization Application (MAA). This registration dossier is divided into ten sections. Each section contains a synopsis, a summary, and references, which in the case of the clinical section are CSRs.