Clinical Research Protocol
8.3.1 Study Sponsor Notification by Investigator 10. 8.3.2 EC/IRB Notification by Investigator 10. 8.3.3 FDA Notification by Sponsor 10. 8.4 Unblinding Procedures 10. 8.5 Stopping Rules 11. 8.6 Medical Monitoring 11. 8.6.1 Internal Data and Safety Monitoring Board 11. 8.6.2 Independent Data and Safety Monitoring Board 12. 9. Data Handling and ... ................
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