DATA REPORTING / REGULATORY REQUIREMENTS AE guidelines and instructions for AE reporting can be found in Section 7.0 (Adverse Events: List and Reporting Requirements) . Dr. Elizabeth Jaffee will be holding the IND for this study. She will comply with all regulated reporting requirements to the FDA. 12.1 Data Collection and Processing All information will be collected on study -specific CRFs by study staff. These data will be reviewed for completeness and accuracy by the Principal Investigator at each site . CRFs will be used to capture study results and data. The study coordinator or other authorized study personnel will transcribe data from source documents onto paper or eCRFs. Before or between visits, the Protocol Chair , IND S ponsor , or de signee may request copies of the CRFs for preliminary medical review. Once the CRFs are complete and source -verified, the investigator must sign and date all required pages, verifying the accuracy of all data contained within the CRF. Protocol Chair J1790 / Version 7.0/ December 10, 2020 69 The Protocol Chair and/or designee is responsible for performing the following tasks: • Coordinating, developing, submitting, and obtaining approval for the protocol as well as its subsequent amendments. • Assuring that all participating institutions are using the correct version of the protocol. • Taking responsibility for the overall conduct of the study at all participating institutions and for monitoring the progress of the study. • Reviewing and ensuring reporting of SAE • Reviewing data from all sites. Coordinating Center (Johns Hopkins University) The Coordinating Center (or its representative) is responsible for performing the following tasks: • Ensuring that IRB approval has been obtained at each participating site prior to the first subject registration at that site, and maintaining copies of IRB approvals from each site. • Monitoring subject registration. • Collecting and compiling data from each site. • Establishing procedures for documentation, reporting, and submitting of AE’s and SAE’s to the Protocol Chair, and all applicable parties. • Facilitating audits by securing selected source documents and research records from participating sites for audit, or by auditing at participating sites. Participating Sites Participating sites are responsible for performing the following tasks: • Following the protocol as written, and the guidelines of Good Clinical Practice (GCP). • Submitting data to the Coordinating Center. • Consent subjects promptly and randomize eligible subject s in EDC . • Providing sufficient ex perienced clinical and administrative staff and adequate facilities and equipment to conduct a collaborative trial according to the protocol. • Maintaining regulatory binders on site and providing copies of all required documents to the Coordinating Center. • Collecting and submitting data according to the schedule specified by the protocol. 12.2 Safety Meetings Scheduled meetings will take place weekly and will include the protocol principal investigator, study coordinator(s), data manager(s), sub-investigators (as appropriate), collaborators (as appropriate), and biostatisticians (as appropriate) involved with the conduct of the protocol. During these meetings matters related to the following will be discussed: safety of protocol participants, validity and integrity of the data, enrollment rate relative to expectation, characteristics of participants, retention of participants, adherence to protocol (potential or real protocol violations), data completeness, and progress of data for objectives. Monthly teleconferences will be scheduled to include the Coordinating Center and the clinical trial sites. During these meetings, the Coordinating Center and clinical trial sites shall discuss the following: study protocol updates , safety data, enrollment status, and progress of data for objectives. J1790 / Version 7.0/ December 10, 2020 70 12.3 Monitoring The SKCCC Compliance Monitoring Program will provide external monitoring for JHU -affiliated sites in accordance with SKCCC DSMP (Version 6.0, 02/21/2019). The SMC Subcommittee will determine the level of patient safety risk and level/frequency of monitoring . Eligibility for all sites will be monitored by the Protocol Chair. Data monitoring of this protocol will occur on a regular basis with the frequency dependent on the rate of subject accrua l and the progress of the study. Additional data and safety monitoring oversight will also be performed by the SKCCC Safety Monitoring Committee (SMC - as defined in the DSMP) and a Medical Expert Committee (MEC) as detailed below. The protocol will be mo nitored internally by the IND Sponsor and the Principal Investigator at each site. External monitoring will occur according to the following guidelines: Johns Hopkins SKCCC : The protocol will be monitored externally by the SKCCC CRO in accordance with SKC CC guidelines. Trial monitoring and reporting will be done through the Safety Monitoring Committee (SMC) at SKCCC. Participating site(s): The protocol will be monitored by the internal CRO at each site. A report of the reviews will be submitted to the Protocol Chair, IND Sponsor, and the SKCCC CRO. Authorized representatives of the Coordinating Center may visit the satellite sites to perform audits or inspections, including source data verification. The purpose of these audits or inspections is to system atically and independently examine all trial -related activities and documents to determine whether these activities were conducted and data were recorded, analyzed, and accurately reported according to the protocol, Good Clinical Practice (GCP), and any ap plicable regulatory requirements. The Medical Expert Committee (MEC) for this clinical study contains three medical oncologists from other disciplines who are not affiliated with this clinical trial protocol. The MEC will review safety data on at least a semi -annual basis. The MEC will provide a written summary of each assessment to the IND Sponsor -Investigator after each meeting. In turn, the study team will forward these summaries to the JHU and IRB, and JHU SKCCC SMC. The operating plan of the MEC will be as follows: • Meetings will be held at least semi -annually, and potentially more frequently if needed. • Meetings will be conducted in -person or via video/teleconference, with a participant sign - in sheet collected at each meeting. • Approximately one week prior to each MEC meeting, the study team will submit the following items to MEC personnel for review and discussion at the meeting (The PI may join the MEC meeting in order to answer any questions the MEC might have): o A summary of the clinical trial’s progress to date; o The latest IRB -approved consent document; o A summary of all adverse events, serious adverse events, deaths, and withdrawals to date; Note that the MEC reserves the right to halt trial accrual or all study activity i f, after review, serious safety concerns warrant this action. If the MEC halts study accrual or all study activity, then the study team must notify the JHU SKCCC SMC, JHU IRB, and the FDA immediately. J1790 / Version 7.0/ December 10, 2020 71 12.4 Study Documentation 12.4.1 Informed Consent an d Authorization for use and Disclosure of Protected Health Information Written informed consent and authorization of use and disclosure of protected health information (PHI) must be obtained from each subject (or the subject’s legally authorized represent ative) before performing any study -specific screening/baseline period evaluations. The ICF and authorization for use and disclosure of PHI, which is prepared by the investigator or the site, must be reviewed and approved by the IND Sponsor, the study monit or (if applicable) , and the site’s IRB before the initiation of the study. 12.4.2 Investigator Study Files Documentation about the investigator and study staff, the IRB and the institution, is required before study site initiation. A list of required documents will be provided by the IND S ponsor or designee to each participating investigator. Copies of these do cuments as well as supplemental information, such as the investigator’s obligations, IB, clinical study protocol and amendments, safety information, investigational agent information, biological samples and laboratory procedures, SRM, study logs and IND S ponsor/investigator/study monitor correspondence will be kept on -site in study site -specific binders. The IND Sponsor or designee will be responsible for maintaining original and backup of all CRF data. The investigator is responsible for maintaining backu p of all electronic data systems used for primary documentation or source documentation. Backup of electronic data will be performed periodically as described in the site -specific SOPs. Backup records must be stored at a secure location on site and backup and recovery logs must be maintained to facilitate data recovery. If an electronic medical records system that is not supported by the IND S ponsor or designee (or is discontinued or decommissioned) is used, the investigator must maintain a system to retrie ve these records or arrange for the transfer of these records to an alternate electronic format or to paper. Changes to any electronic records require an audit trail, in accordance with 21 CFR 11.10(e), and should include who made the changes and when and why the changes were made. An audit trail is defined as a secure, computer -generated, time -stamped electronic record that will allow reconstruction of the course of events relating to the creation, modification and deletion of an electronic record. Audit trails must be created incrementally, in chronological order and in a manner that does not allow new audit trail information to overwrite existing data. Audit trails should be in a readable format and readily available at the study site and any other locat ion where electronic study records are maintained. Audit trails are generated automatically for eCRFs . The investigator is responsible for maintaining audit trails of all electronic data systems used for primary documentation or source documentation. 12.4.3 Case Report Forms and Source Documentation J1790 / Version 7.0/ December 10, 2020 72 The investigator must make study data accessible to the site monitor, to other authorized representatives of the IND Sponsor (or designee) and to the appropriate regulatory authority inspectors. The original CRF for each subject will be checked against source documents at the study site by the site monitor. 12.4.4 Retention of Study Documents According to ICH E6, Section 4.9, all CRFs, as well as supporting paper and electronic documentation and administrati ve records, must be retained for at least 2 years after the last approval of a marketing application and until there are no pending or contemplated marketing applications, or at least 2 years have elapsed since the formal discontinuation of clinical develo pment of an individual product. Longer retention periods may apply. The IND S ponsor will notify investigators as to when documents no longer need to be retained. No study documents will be destroyed or moved to a new location without prior written approval from the IND Sponsor . If the investigator relocates, retires or withdraws from the clinical study for any reason, all records required to be maintained for the study should be transferred to an agreed -upon designee, such as another investigator at the ins titution where the study was conducted. Audit trails for electronic documents must be retained for a period at least as long as that required for the subject electronic records to which they pertain. The investigator must retain either the original or a c ertified copy of audit trails. 12.4.5 Data Confidentiality and Subject Anonymity All information about the nature of the proposed investigation provided by the IND Sponsor or their representative to the investigator (with the exception of information required by law or regulations to be disclosed to the IRB, the subject or the appropriate regulatory authority) must be kept in confidence by the investigator. The anonymity of participating subjects must be maintained. Subjects will be identified by their initials and an assigned subject number on CRFs and other documents retrieved from the site or sent to the IND Sponsor, BMS, regulatory agencies, or central laboratories/reviewers. Documents that identify the subject (e.g., the signed ICF) must be mainta ined in strict confidence by the investigator, except to the extent necessary to allow auditing by the appropriate regulatory authority, the study monitor, IND Sponsor or their representative. 13.