39 6.3.2 Methods for Evaluation of Measurable Disease ....................................................... 40 6.3.3 Response Criteria Definitions ................................................................................... 41 6.3.4 Duration of Response ................................................................................................ 42 Toxicity Criteria ............................................................................................................ 43 7 SAFETY REPORTING REQUIREMENTS/DATA AND SAFETY MONITORING PLAN 43 Definitions.....................................................................................................................4 3 7.1.1 Adverse Ev ent ........................................................................................................... 43 7.1.2 Suspected Adverse Reaction ..................................................................................... 43 7.1.3 Unexpected Adverse Reaction.................................................................................. 43 7.1.4 Serious....................................................................................................................... 43 7.1.5 Serious Adverse Event .............................................................................................. 43 7.1.6 Disability ................................................................................................................... 4 4 7.1.7 Life-Threatening Adverse Drug Experience ............................................................. 44 7.1.8 Protocol Deviation (N IH Definition) ........................................................................ 44 7.1.9 Non-Compliance (NIH Definition) ........................................................................... 44 7.1.10 Unanticipated Problem.......................................................................................... 44 NIH INTRAMURAL-IRB and Clinical Director (CD) Reporting ............................... 44 7.2.1 NIH Intramural IRB and NCI CD Expedite d Reporting of Unanticipated Problems and Deaths .................................................................................................................... ......... 44 7.2.2 NIH Intramural IRB Requirements for PI Reporting at Continuing Review ........... 45 7.2.3 NIH Intramural IRB Reporting of IND Safety Reports ............................................ 45 IND Sponsor Reporting Criteria ................................................................................... 45 7.3.1 Reporting Pregnancy ................................................................................................. 46 Safety Reporting Criteria to the Pharmaceutical Collaborator ..................................... 46 Institutional Biosafety Committee (IBC) Reporting Criteria ........................................ 47 7.5.1 Serious Adverse Event Reports to IBC ..................................................................... 47 7.5.2 Annual Reports to IBC.............................................................................................. 47 Data and Safety Monitoring Plan .................................................................................. 48 7.6.1 Principal Investigator/Research Team ...................................................................... 48 7.6.2 Sponsor Monitoring Plan .......................................................................................... 48 7.6.3 Safety Monitoring Committee (SMC) ...................................................................... 49 8 STATISTICAL CONS IDERATIONS ..........................................................................