15.0 STUDY MONITORING, AUDITING, AND INSPECTING 15.1 Study Monitoring Plan This study will be monitored according to the Sponsor Data and Safety Monitoring Plan. Interim Monitoring Visits will be conducted during the course of the study. The Monitors will assure that submitted data are accurate and in agreement with source documentation; verify that investigational products are properly stored and accounted for; verify that subject consent for study participation has been properly obtained and documented; confirm that research subjects entered into the study meet inclusion and exclusion criteria; and assure that all essential documentation required by Good Clinical Practices (GCP) guideline s are appropriately filed. At the end of the study, Monitors will conduct a close -out visit and will advise on storage of study records and disposition of unused investigational products. The investigator will allocate adequate time for such monitoring a ctivities. The Investigator will also ensure that the monitor or other compliance reviewer is given access to all the above noted study- related documents and study related facilities (e.g. pharmacy, diagnostic laboratory, etc.), and has adequate space to conduct the monitoring visit. 15.2 Auditing and Inspecting The investigator will permit study -related monitoring, audits, and inspections by the IRB, the Sponsor, government regulatory bodies, and University compliance groups. The investigator will ensure the capability for inspections of applicable study -related facilities (e.g. pharmacy, diagnostic laboratory, etc.). Participation as an investigator in this study implies acceptance of potential inspection by government regulatory authorities and applicable University compliance offices. The Principal Investigator must notify the Sponsor in real -time if an audit/inspection notification is received. 16.0 ETHICAL CONSIDERATIONS This study is to be conducted according to US and international standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Institutional research policies and procedures. This protocol and any amendments will be submitted to a properly cons tituted independent Institutional Review Board (IRB), in agreement with local legal prescriptions, for formal approval of the study conduct. The decision of the IRB concerning the conduct of the study will be made in writing to the investigator and a copy of this decision will be provided to the sponsor before commencement of this study. All subjects for this study will be provided a consent form describing this study and providing sufficient information for subjects to make an informed decision about their participation in this study. This consent form will be submitted with the protocol for review and approval by the IRB for the study. The formal consent of a subject, using the IRB -approved consent form, must be obtained before that subject is submitted to any study procedure. The protocol is listed on clinicaltrials.gov. DC Vaccine for Colorectal Cancer Page 32 of 34 Version 7.11-11-2021 CONFIDENTIAL This protocol is the property of the University of Pennsylvania. Do not disclose or use except as authorized in writing by the study spons or. 17.0 STUDY FINANCES 17.1 Funding Source This study wil l be funded by the Parker Institute for Cancer Immunotherapy and the National Institutes of Health (NIH) . 17.2 Conflict of Interest All University of Pennsylvania Investigators will follow the University of Pennsylvania Policy on Conflicts of Interest Related to Research. 17.3 Subject Stipends or Payments There is no subject stipend/payment for participation in this protocol. 18.0 PUBLICATI ON PLAN Publication of the results of this trial will be governed by University of Pennsylvania policies. Neither the complete nor any part of the results of the study carried out under this protocol will be published or passed on to any third party without the co nsent of the Sponsor. Any investigator involved with this study is obligated to provide the Sponsor with complete test results and all data derived from the study. DC Vaccine for Colorectal Cancer Page 33 of 34 Version 7.11-11-2021 CONFIDENTIAL This protocol is the property of the University of Pennsylvania. Do not disclose or use except as authorized in writing by the study spons or.