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.
