................................ ....52 7.5 INSTITUTIONAL BIOSAFETY COMMITTEE (IBC) REPORTING CRITERIA ............................... 53 7.5.1 Serious Adverse Event Reports to IBC ................................ ................................ ......53 7.5.2 Annual Reports to IBC ................................ ................................ ............................... 53 7.6 DATA AND SAFETY MONITORING PLAN ................................ ................................ .............. 54 7.6.1 Principal Investigator/Research Team ................................ ................................ ........ 54 7.6.2 Sponsor Monitoring Plan ................................ ................................