26 8.1.4 Storage and Time Limitations .............................................................................. 27 8.1.5 Administration ..................................................................................................... 27 Page 8 of 50 IRB Protocol No. 12367 Version Date: 10/24/2017 Version: 09 8.1.6 T oxicity ................................................................................................................ 27 8.2 Radiation therapy ................................................................................................. 29 8.2.1 Tr eatment Pla n: .................................................................................................... 29 8.2.2 Toxicity: ............................................................................................................... 29 9.0 Correlative/Special Studies ............................................................................................... 30 9.1 B lood Collection .................................................................................................. 30 9.2 Immune Assays ................................................................ .................................... 30 9.3 Analysis of PBMCs ............................................................................................. 31 10.0 Study Calendar .................................................................................................................. 33 11.0 Endpoint Evaluation Criteria/Measurement of Effect....................................................... 35 11.1 Measurability of lesions ....................................................................................... 35 11.2 Objective status .................................................................................................... 35 12.0 Data Reporting/Protocol Deviations ................................................................................. 36 12.1 Confidentiality and Storage of Records ............................................................... 36 12.2 Subject Consent Form .......................................................................................... 36 12.3 Data Collection Forms and Submission Schedule ............................................... 37 12.4 Protocol Deviations .............................................................................................. 37 12.5 Deviation Policy .................................................................................................. 37 12.5.1 R eporting of Deviations .......................................................................... 37 12.5.2 Resolving Disputes ................................................................................. 37 13.0 Statistical Considerations .................................................................................................. 38 13.1 Study Design ........................................................................................................ 38 13.2 Sample Size Accrual Rate .................................................................................... 38 13.3 Statistical Analysis Plan ....................................................................................... 38 14.0 H uman Subject Issues ....................................................................................................... 39 14.1 Inst itutional Review Board .................................................................................. 39 14.2 Rec ruitment of Subjects ....................................................................................... 39 14.3 A dvertisements .................................................................................................... 39 14.4 Study location and Performance Sites ................................................................. 39 14.5 Confidentiality ..................................................................................................... 39 14.6 Financial Obligations and Compensation ............................................................ 39 14.7 Informed Consent Processes ................................................................................ 40 15.0 References .........................................................................................................................