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Memorial Sloan Kettering Cancer Center (MSKCC) is responsible for overseeing all fiscal and administrative arrangements with the consortium

Memorial Sloan Kettering Cancer Center (MSKCC) is responsible for overseeing all fiscal and administrative arrangements with the consortium

The MSKCC Office of Clinical Research includes a Multicenter Protocol Group that provides regulatory and administrative support, and a Clinical Research Quality Assurance group responsible for auditing and monitoring investigator-initiated protocols. Participating sites will be monitored on an ongoing basis to ensure good data management, HIPAA compliance, and appropriate use of funds, and to address any local administrative challenges that may hinder recruitment. Monthly conference calls are instituted to discuss administrative and clinical updates. A monthly project update will be distributed to all Principal Investigators, Coordinators, and project affiliates. In addition, individual site training and new staff orientations will be offered throughout the year. For quality control purposes, an annual review will be performed to assess each site with respect to matters of recruitment, fiscal management, and data quality. Low-accruing sites will be evaluated to ensure that they have adequate staff, clear communication channels, and a screening and recruitment plan in place.

Ethics, informed consent and safety

The Institutional Review Board (IRB) of MSKCC approved the final protocol, and the appropriate approvals have been obtained by each participating site. Before protocol-specified procedures are carried out, investigators or their staffs will explain to patients the full details of the protocol and study procedures, as well as the risks involved, prior to their inclusion in the trial. Patients will also be informed that they are free to withdraw from the study at any time. All patients must sign an IRB-approved consent form indicating their consent to participate. This consent form will meet the requirements of the Code of Federal Regulations and the Institutional Review Boards of all participating centers. The consent form includes the nature and objectives, potential toxicities and benefits, of the intended study; the required length of therapy and the likely follow-up; alternatives to the proposed therapy (including available standard and investigational therapies); supportive care; the name(s) of the investigator(s) responsible for the protocol; the right of the patient to accept or refuse treatment, or to withdraw from the study.

Patient safety is of utmost importance. To ensure that patients are not put at undue risk, stopping guidelines and vigilant monitoring practices are in place. Safety will be assessed through documentation of adverse events during TNT and after surgery. Adverse events will be graded according to NCI CTCAE version 4, and surgical complications will be graded according to the Clavien-Dindo Classification . Serious adverse events (SAEs) will be reported to the Institutional Review Board and recorded electronically.

To protect patients treated non-operatively against the risk of local tumor progression during follow-up, we will monitor continuously for resection with positive margins (R1 resection) based on repeated significance level. To protect patients against the risk of tumor progression, we will conduct an interim evaluation with clinical exam and radiology studies during neoadjuvant treatment. Patients with diagnosis of tumor progression during treatment will be removed from the study and treated according to standard of care. These cases will be reviewed by the Data and Safety Monitoring Committee. We will regularly monitor for adverse events and surgical complications. The results will be reviewed periodically by the Data and Safety Monitoring Committee to protect against the risk of increased adverse events and surgical complications.

Physicians qualified to conduct the informed consent process must be certified in the protection of human subjects for research

The Principle Investigator (PI), Co-Investigators, research manager (KA), research project coordinator, and research service associate will be responsible for ensuring that all consent forms and electronic data gathered during the course of the study are stored in locked cabinets, a secure database, or password-protected HIPAA-approved electronic files. This applies to all consortium sites, and the MSKCC PI will be responsible for overseeing compliance. Remote monitoring and auditing will be performed on all consortium sites to ensure compliance. Clinical information will be entered into a HIPAA-compliant, confidential, password-protected clinical database at MSKCC, which only the PI https://hookupdate.net/es/hitch-review/, research manager, research project coordinator, and research service associate will be able to access. The research records will not be included in the patient’s hospital medical record.

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