External Data Monitoring Committee Not applicable. 10.2. Monitoring of the Study All aspects of the study will be carefully monitored, by the Sponsor or its designee, for compliance with applicable government regulation with respect to current GCP and current standard operating procedures. The determination of the extent and nature of monitoring will be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the study. Prior to initiation of the study, SELLAS or its designee will visit the study site to review with the site personnel information about the study treatment, protocol, and other regulatory document requirements, source document requirements, eCRFs, monitoring requirements, and procedures for reporting AEs including SAEs. During the study, a monitor will visit the investigator and study site at periodic intervals, in addition to maintaining necessary telephone and letter contact. The monitor will assess the site for compliance with regulatory documentation and will focus on accurate and complete recording of data on eCRFs from source documents, adherence to protocol and GCP, SAE reporting, and drug accountability records. At all times, study-related correspondence, patient records, original signed consent forms, patient privacy documentation, records of the distribution and use of all investigational products, and electronic copies of eCRFs, if applicable, should be maintained on file. The investigator must agree to allow the monitor access to the clinical supplies, dispensing, and storage areas and to all relevant clinical files of the study patients. Key study personnel must be available to assist the monitor during the visits . In addition, the investigator should make every effort to be available for 30 to 60 minutes at the time of the clinical monitoring check-out meeting at the end of each day of the monitoring visit to discuss findings and needed assistance to complete the monitoring visit successfully. SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/ MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 229 10.2.1. Inspection of Records Investigators and institutions involved in the study will permit study-related monitoring, audits, IRB/IEC review, and regulatory inspections by providing direct access to all study records. In the event of an audit, the investigator agrees to allow the sponsor, representatives of the sponsor, or a regulatory agency (e.g., FDA or other regulatory agency) access to all study records. The investigator should promptly notify SELLAS and CRO of any audits scheduled by any regulatory authorities and promptly forward copies of any audit reports received to the sponsor. 10.3. Management of Protocol Amendments and Deviations 10.3.1. Modification of the Protocol Each site investigator must not implement any deviation from or changes to the protocol without approval by SELLAS and prior review and documented approval/favorable opinion from the IRB, except where necessary to eliminate immediate hazards to study patients or when the changes involve only logistical or administrative aspects of the study ( e.g., change in monitors, change of telephone numbers). Amendments to the protocol must be submitted in writing to the investigator’s IRB for approval before patients can be enro lled into an amended protocol. The site investigator will report to the IRB and SELLAS and SELLAS will report to the regulatory authority any changes in the research protocol and all unanticipated problems involving risks to human patients and others, and no changes will be made in the research activity without IRB approval . SELLAS will report to the regulatory authority any changes in the research protocol. SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/ MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 230 10.3. 2. Protocol Deviations A deviation from the protocol is an unintended or unanticipated departu re from the procedures or processes approved by the sponsor and the IRB and agreed to by the investigator. A significant deviation occurs when there is nonadherence to the protocol by the patient or investigator that results in a significant, additional ri sk to the patient. Significant deviations can include nonadherence to inclusion or exclusion criteria, enrollment of the patient without prior sponsor approval, or nonadherence to regulatory authority regulations or ICH GCP guidelines and will lead to the patient being withdrawn from the study (Section 4.2). There should be no deviations or departures from the protocol. The investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard to study patients without prior IRB approval. If an emergency occurs that requires departure from this protocol, the investigator or other physician in attendance in such an emergency will, if circumstances and time permit, contact the medical monitor. Such contacts will be made to permit a decision as to whether or not the patient will be continued on the study. As soon as possible after such an occurrence, the implemented deviation or change, the reasons for it, and any proposed protocol amendments should be submitted to the IRB for review and approval, to the sponsor for agreement (if not already done), and to the regula tory authorities, if required. The site investigator or designee must clearly document and explain in the patient’s source documentation any deviation from the approved protocol . Protocol deviations will also be documented by the clinical monitor throughou t the course of monitoring visits. Principal investigators will be notified in writing by the monitor of deviations. The sponsor and IRB should be notified of all protocol deviations in a timely manner. 10.4. Study Termination Although SELLAS has every intention of completing the study, the sponsor reserves the right to close an investigational site or terminate the study at any time for clinical or administrative SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/ MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 231 reasons. In addition, the study may be stopped at a site at any time by the site investigator with appropriate notification.