The investigator is responsible for the procurement of data and for the quality of data recorded on the CRFs. CRFs will be provided in electronic form. Only authorized study site personnel will record or change data on the CRFs. If data is not entered on the CRFs during the study visit, the data will be recorded on paper, and this documentation will be considered source documentation. Changes to a CRF will require documentation of the reason for each change. An identical (electronic/paper) version of the complete set of CRFs for each subject will remain in the investigator file at the study site in accordance with the data retention policy (see Section 11.6.4). The handling of data by the sponsor, including data quality assurance, will compl y with regulatory guidelines ( e.g., ICH GCP) and the standard operating procedures of the sponsor. Data management and control processes specific to the study will be described in the data management plan. 11.6.2 Direct Access to Source Data, Source Documents , and Study Records The investigator/study site will cooperate and provide direct access to study documents and data, including source documentation for monitoring by the study monitor, audits by the sponsor or sponsor’s representatives, review by the IEC, and inspections by applicable regulatory authorities, as described in the Clinical Trial Agreement. If contacted by an applicable regulatory authority, the investigator will notify the sponsor of contact, cooperate with the authority, provide the sponsor with copies of all documents received from the authority, and allow the sponsor to comment on any responses, as described in the Clinical Trial Agreement . 11.6.3 Source Data Per ICH GCP, source data are defined as all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 74 of 81 CONFIDENTIAL trial that are necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies), which may be in paper and/or electronic format. Source data for this study comprise the following: hospital records, medical records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, outcomes reported by subjects, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x- rays, subject files, and records kept at the pharmacy, at the laboratories and at medico- technical departments involved in the clinical study. No data will be entered directly onto the CRF. For additional information on study documentation and CRFs, see Section 11.6.1. 11.6.4 Document and Data Retention The investigator will retain study documentation and data (paper and electronic forms) in accordance with applicable regulatory requirements and the document and data retention policy, as described in the Clinical Trial Agreement. 11.7 Non-Compliance with the Protocol The investigator may deviate from the protocol only to eliminate an apparent immediate hazard to the subject. In the event(s) of an apparent immediate haz ard to the subject, the investigator will notify the sponsor immediately by phone and confirm notification to the sponsor in writing as soon as possible, but within 1 calendar day after the change is implemented. The sponsor will also ensure the responsibl e EC and relevant competent authority is notified of the urgent measures taken in such cases according to local regulations. If monitoring and/or auditing identify serious and/or persistent non- compliance with the protocol, the sponsor may terminate the investigator’s participation. The sponsor will notify the EC and applicable regulatory authorities of any investigator termination. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 75 of 81 CONFIDENTIAL 11.8 Financing and Insurance The investigator will comply with investigator financing, investigator/sponsor insurance, and subject compensation policies, if applicable, as described in the Clinical Trial Agreement. 11.9 Publication Policy The investigator will comply with the publication policy as described in the Clinical Trial Agreement. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 76 of 81 CONFIDENTIAL 12 REFERENCES Bever KM and Le DT. An Expanding Role for Immunotherapy in Colorectal Cancer.