FDA, and the respective national or local health authorities to inspect facilities and records relevant to this study. 6.6 Data Safety Monitoring Plan A Data Safety Monitoring Plan (DSMP) (Appendix F) describing the CRO internal monitoring plan includes data safety and integrity and site initiation/QA monitoring, as well as external monitoring plan - the Data Safety Monitoring Board (DSMB) charter and responsibilities. 6.7 Study medication accountability The study drug will be provided by Galena Biopharma.