4.9 DATA QUALITY ASSURANCE Accurate, consistent, and reliable data will be ensured through the use of standard practices and procedures. Data collection procedures are described in Section 6.6. Data monitoring and assurance procedures are described in the Data Safety Monitoring Plan (Appendix K). 5. REPORTING OF ADVERSE EVENTS Reporting of adverse events will be performed in accordance with the Data Safety Monitoring Plan (Appendix K) and Sections 5.2 and 5.3 below. 5.1 ADVERSE EVENT AND REPORTING DEFINITIONS With the occurrence of an adverse event, the first concern will be for the safety of the subject. Investigators are required to report to the IRB, medical monitor, clinical research organization (CRO) Quality Assurance Officer, or her designee and CRO Regulatory Affairs Officer any serious adverse event, whether expected or unexpected, and which is assessed by the investigator to be reasonably or possibly related to or caused by Herceptin or the vaccine components. Elective surgeries resulting in hospitalization and unrelated to the study agents will not be reported as SAEs (e.g., breast reconstruction, etc.). All events meeting the outlined criteria will be reported for the time period beginning with any amount of exposure to Herceptin or vaccine components through the protocol-defined follow-up period. The Regulatory Affairs Officer will then report the event to the Sponsor/Investigator. The IND Sponsor/Investigator or Sponsor/Investigator’s representative will report these to the FDA and financial sponsors, Genentech Drug Safety and Galena Biopharma. The reporting requirements/instructions of AEs from IND Sponsor/Investigator and/or representative to Genentech, Inc. are stated in Appendix N.