Monitoring processes specific to the study will be described in the clinical monitoring plan. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 72 of 81 CONFIDENTIAL 11.4 Safety Monitoring Accrual, withdrawals from treatment, all toxicities, and AEs will be monitored during the study. Reports should be reviewed every 2 weeks by the safety review team from one week after the study opens unti l it closes. If 2 subjects experience a primary safety endpoint ( Section 9.4), or 1 subject experiences a ≥Grade 4 AE that is probably or definitely related to study treatment, enrollment will be suspended. Depending on the severity of the AE, study treatment administration to subjects may be terminated, pending a subsequent decision by the study team on how to proceed. When the last subject reaches Week 12, the safety review team will review all available safety data, including hematology, chemistries, tumor biomarkers, viral load data, and all clinical events. 11.5 Audits The sponsor and/or sponsor’s representatives may conduct audits to evaluate study conduct and compliance with the protocol, standard operating procedures, other written instructions/agreements, ICH GCP, and applicable national and local regulatory guidelines/requirements. The investigator will permit auditors to visit the study site, as described in the Clinical Trial Agreement. Auditing processes specific to the study will be described in the audit plan. 11.6 Documentation 11.6.1 Case Report Forms and Study Records The investigator will maintain complete and accurate paper format study documentation in a separate file. Study documentation may include information defined as “source data” (see Section 11.6.3), records detailing the progress of the study for each subject, signed informed consent forms, correspondence with the EC and the study monitor/sponsor, screening information, CRFs, SAE reports (SAERs), laboratory reports (if applicable), and data clarifications requested by the sponsor. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 73 of 81 CONFIDENTIAL The investigator will comply with the procedures for data recording and reporting. Any corrections to paper study documentation must be performed as follows: 1) the first entry will be crossed out entirely, remaining legible; and 2) each correction must be dated and initialed by the person correcting the entry; the use of correction fluid and erasing are prohibited.