Document Preparation
Nelson H Schimmel · 2020
The regulations covering the optional expanded summary provide for the presentation of highlights of the preclinical and clinical activities that make up the submission. In an attempt to reduce the area of paper required for explanatory remarks on computer output, many computer operators tend to use symbols or codes to identify tables or lists. In most situations, the transfer of information from the case report form to the computer data base requires the intervention of data entry specialists. A growing number of sponsors prepare a separate statistical submission to accompany the application in which the full statistical analyses of each study, the statistics of the total application are presented. Graphics, especially computer-generated graphics, are relatively new in regulatory submissions. All word processing or computer-gen erated or -stored information could be electronically transferred. The full study report should contain all the data necessary to allow the reviewer to conduct his own reanalysis of the study without reference to the raw data.