A summary of any instances of non-compliance3. A tabular summary of the f ollowing adverse events: Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 34xAll Grade 2 unexpected events that are possibly, proba bly or definitely related to the research; xAll Grade 3 and 4 events that are possibly, probably or definit ely related to the research; xAll Grade 5 events rega rdless of attribution; xAll serious events rega rdless of attribution. Note: Grade 1 events are not r equired to be reported. 7.2.3 NCI-IRB Reporting of IND Safety Reports Only IND Safety Reports that meet the definition of an unanticipated problem will need to be reported to the NCI IRB. IND S PONSOR REPORTING CRITERIA From the time the subject receive s the investigational agent/in tervention to the time of the second follow-up evaluation, the investig ator must immediately report to the sponsor, using the mandatory MedWatch form 3500a or e quivalent, any serious adverse event, whether or not considered drug related, including those listed in the protocol or investigator brochure and must include an assessment of whether there is a reasonable possibility that the drug caused the event. For serious adverse events that occur after the second follow-u p evaluation, only those events that have an attribu tion of at least possibl y related to the ag ent/intervention will be reported. Required timing for reporting per the above guidelines: xDeaths (except death due to progre ssive disease) must be report ed via email within 24 hours. A complete report must be submitted within one business day. xOther serious adverse events as well as deaths due to progressiv e disease must be reported within one business day Events will be submitted to the Center for Cancer Research (CCR ) at: CCRsafety@mail.nih.gov and to the CCR PI and study coordinator . 7.3.1 Reporting Pregnancy Maternal Exposure If a patient becomes pregnant durin g the course of the study, t he study treatment should be discontinued immediately and the pregnancy reported to the Spon sor. The potential risk of exposure of the fetus to the inve stigational agent(s) or chemot herapy agents(s) should be documented in box B5 of the MedWatc h form “Describe Event or Pr oblem”. Pregnancy itself is not regarde d as an SAE. However, as patients who become pregnant on study risk intrauterine exposure of t he fetus to agents which may be teratogenic, the CCR is requesting that pregnancy should be reporte d in an expedited manner as Grade 3 “Pregnancy, puerperium and perinatal conditions -Other (pregnancy) ” under the Pregnancy, puerperium and perinatal conditions SOC. Congenital abnormalities or birt h defects and spontaneous misca rriages should be reported and handled as SAEs. Elective abor tions without complications shoul d not be handled as AEs. The outcome of all pregnancies (spontan eous miscarriage, elective t ermination, ectopic pregnancy, normal birth, or congenital a bnormality) should be followed up and documented. Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 35If any pregnancy occurs in the c ourse of the study, then the in vestigator should inform the Sponsor within one day, i.e., immediately, but no later th an 24 hours of when he or she becomes aware of it. The designated Sponsor represent ative will work with the invest igator to ensure that all relevant information is provided to the S ponsor within 1 to 5 calendar days for SAEs and within 30 days for all other pregnancies.The same timelines apply when outcome information is available. Paternal Exposure Male patients should refrain from fathering a child or donating sperm during the study and for 120 days after the last vaccination.Pregnancy of the patient’s part ner is not considered to be an AE. However, the outcome of all pregnancies (spontaneous miscarri age, elective termination, ectopic pregnancy, normal birth, or congenital abnormality) occurring from the date of the first do se until 120 days after the last dose should, if possible, be f ollowed up and documented. INSTITUTIONAL BIOSAFETY COMMITTEE (IBC) R EPORTING CRITERIA 7.4.1 Serious Adverse Event Reports to IBCSerious adverse events are not r equired to be reported to the NIH IBC, as the research is not subject to the NIH Guidelines for Research Involving Re combinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) . Therefore, the reporting requi rements as described in Appendi x M do not apply for this study. 7.4.2 Annual Reports to IBCWithin 60 days after the one-yea r anniversary of the date on wh ich the IBC approved the initial protocol, and after each subseque nt anniversary until the trial is completed, the Principal Investigator (or delegate) sha ll submit the information describ ed below. Alternatively, the IRB continuing review report can be s ent to the IBC in lieu of a se parate report. Please include the IBC protocol number on the report. Clinical Trial Information A brief summary of the status of the trial in progress or compl eted during the previous year. The summary is required to include t he following information: xthe title and purpose of the trial xclinical site xthe Principal Investigator xclinical protocol identifiers; xparticipant populati on (such as disease indication and general age group, e.g., adult or pediatric); xthe total number of participan ts planned for inclusion in the trial; the number entered into the trial to date whos e participation in the trial was complete d; and the number who dropped out of the trial with a br ief description of the reasons Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 36xthe status of the trial, e.g., open to accrual of subjects, clo sed but data collection ongoing, or fully completed, xif the trial has been complete d, a brief description of any stu dy results. Progress Report and Data Analysis Information obtained during the previous year's clinical and no n-clinical investigations, including: xa narrative or tabul ar summary showing the most frequent and mo st serious adverse experiences by body system xa summary of all serious adverse events submitted during the pa st year xa summary of serious adverse eve nts that were expected or consi dered to have causes not associated with the use of the ge ne transfer product such as di sease progression or concurrent medications xif any deaths have occurred, the number of participants who die d during participation in the investigation and causes of death xa brief description of any inf ormation obtained that is pertine nt to an understanding of the gene transfer product’s actions , including, for example, inform ation about dose-response, information from controlled trials, and information about bioav ailability. DATA AND SAFETY MONITORING PLAN 7.5.1 Principal Investigator/Research Team The clinical research team wi ll meet on a regular basis when pa tients are being actively treated on the trial to discuss each patie nt. Decisions about dose level enrollment and dose escalation if applicable will be made based on the toxicity data from prior p atients. All data will be collected in a timely manner and reviewed by the Principal Investigator. Adverse events will be reported as require d above. Any safety concerns, new information that might affect either the ethical and o r scientific condu ct of the trial, or protocol deviations will be immediately reported to the IRB using iRIS. The Principal Investigator will review adverse event and respon se data on each patient to ensure safety and data accuracy. The Pr incipal Investigator will person ally conduct or supervise the investigation and provi de appropriate deleg ation of responsibilities to other members of the research staff. 7.5.2 Sponsor Monitoring Plan As a sponsor for clinical trials, FDA regulations require the C CR to maintain a monitoring program. The CCR’s program allo ws for confirmation of: study da ta, specifically data that could affect the interpretation of pr imary study endpoints; adherence to the protocol, regulations, and SOPs; and human subject’s prot ection. This is done through inde pendent verific ation of study data with source docume ntation focusing on: xInformed consent process xEligibility confirmation xDrug administration and accountability xAdverse events monitoring Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 37xResponse assessment The monitoring program also extends to multi-site research when the CCR is the coordinating center. This trial will be monitored by personnel employed by a CCR cont ractor. Monitors are qualified by training and experience to m onitor the progress of clinical trials.