67 9.2 STUDY DOCUMENTATION .............................................................................................................. 67 9.2.1 Investigator Information ........................................................................................................ 67 9.2.2 Investigator Study Files ......................................................................................................... 67 9.2.3 CRFs and Source Documentation .......................................................................................... 68 9.2.4 Retention of Study Documents .............................................................................................. 68 9.3 CONFIDENTIALITY ............................................................................................................................ 69 9.3.1 Data ....................................................................................................................................... 69 9.3.2 Subject Anonymity ................................................................................................................ 69 9.4 PROTOCOL COMPLIANCE ................................................................................................................ 69 9.5 STUDY MONITOR FUNCTIONS AND RESPONSIBILITY ............................................................. 70 9.6 GENERAL INFORMATION ................................................................................................................