Tracking data to ensure the highest quality is important. Although some data fields on the Flow Sheets will not be entered into EDC, they must be captured on the Flow Sheets for monitoring purposes. Edit Checks will fire in real time as data is being entered in the EDC system to ensure quality data is complete, consistent, and clean. In addition to edit checks, queries will be generated as Discrepancy Notes by the data manager and monitors. Sites will have ten business days to update a query. It is the responsibility of the coordinator at each site to ensure that all data has been submitted. The CRO QA Officer or Sponsor’s representative will perform an audit of the site-specific Flow Sheets and will match them against source documents to ensure the quality of data coming to the Database Manager in the EDC per the internal monitoring plan. The database, hosted by OpenClinica, resides in a SAS 70 Type II data center and meets ISO 17799 standards for information security. The EDC system is HIPAA and 21 CFR part 11 compliant with robust audit logs, controlled user access and electronic signature/password management. In addition to the site user, the Data Manager, the Monitors, the Overall Study PI and Sponsor/Sponsor representative have access to the database. Each user is assigned a role which grants limited access and functionalities dependent upon that specific role. Data extracted from the database may be accessed by other study collaborators and investigators at the discretion of the Overall Study Principal Investigator. CONFIDENTIAL Page 49 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 Data Safety Monitoring Plan A Data Safety Monitoring Plan (DSMP) (Appendix K) 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 If the study drug will be provided by Genentech and Galena Biopharma, the recipient will acknowledge receipt of the drug by returning the INDRR-1 form indicating shipment content and condition. Damaged supplies will be replaced. Accurate records of all study drug dispensed from and returned to the study site should be recorded by using the institution’s drug inventory log or the NCI drug accountability log. All partially used or empty containers should be disposed of at the study site according to institutional standard operating procedure. Return unopened, expired, or unused study drug with the Inventory of Returned Clinical Material form as directed by Genentech and Galena Biopharma. 6.8 DISCLOSURE OF DATA Subject medical information obtained by this study is confidential, and disclosure to third parties other than those noted above is prohibited.