4090.13,60 Contents Page 1 of 1 FSH 4090.13 - GOOD LABORATORY PRACTICES HANDBOOK WO AMENDMENT 4090.13-93-1 EFFECTIVE 11/10/93 CHAPTER 60 - PROTOCOL AND CONDUCT OF A STUDY Contents 61 PROTOCOLS 61.1 Description 61.2 Contents 61.3 Amendments 61.4 Deviations 61.5 Review and Approval 62 CONDUCTING STUDIES 62.1 Accordance with Protocol 62.2 Labeling Specimens 62.3 Collecting Raw Data 62.31 Manual Data Collection 62.32 Automated Data Collection