Upon the patient’s permission, medical information may be given to his or her personal physician or other appropriate medical personnel responsible for his or her welfare. Data generated by this study must be available for inspection upon request by representatives of the U.S. FDA, national and local health authorities, Galena Biopharma, and the IRB for each study site, if appropriate. 6.9 Retention of records U.S. FDA regulations (21 CFR §312.62[c]) require that records and documents pertaining to the conduct of this study and the distribution of investigational drug, including CRFs, consent forms, laboratory test results, and medication inventory records, must be retained by the Principal Investigator for two years after marketing application approval. If no application is filed, these records must be kept two years after the investigation is discontinued and the U.S. FDA and the applicable national and local health authorities are notified.