A Master Format for Clinical Reports

Abstract

The objective of the master report is to obtain the same high-quality image and text for all clinical reports in conformity with International Conference for Harmonization (ICH) recommendations, as well as to simplify and shorten the process of medical writing. The suggested ICH format for clinical study reports, guidelines developed by the Food and Drug Administration (FDA), and recently published articles were integrated, providing a model clinical report including sample abbreviations and references, suggested text for all chapters, and prototype tables. The master report was then formatted according to the electronic classification scheme used by the sponsor. The master report is a 64-page document in English that includes a guide for the use of the master report and Preformatted text and tables in conformity with ICH guidelines. Preformatted text, tables, and a diskette in ICH style were developed. Training has been prepared to facilitate the report's use.