Data management and safety monitoring
toxicity, Cancer
CANCER
REDCap will be used to collect and maintain all treatment, toxicity, efficacy, and AE data for all enrolled subjects. REDCap is a secure data management software system that is fully supported by Weill Cornell Medicine’s Clinical and Translational Science Center (CTSC). REDCap provides audit trails that track the creation and modification of records that include user identification and timestamp. Once data is entered into the system, the data is subject to validation procedures that are executed immediately, upon saving the electronic case report form page, or during the batch validation process. Validation failures will generate a discrepancy that can be corrected by data managers or the project data manager depending on the database account privileges. Once the discrepancy is corrected, the data is marked as clean, and an audit trail is recorded by the system.Security measures that will be taken to protect patient data will include firewall technology and database level security which will be achieved by assigning roles and privileges to different levels of users and by requiring that the users authenticate themselves using user identification and password. Additional security for data transfer between remote clients and servers will be achieved by using digital certificates. All data will be backed-up to tape periodically according to the institutional standard operating procedures. All data will be stored for at least 5 years following the termination of the study.The Weill Cornell Medicine Data Safety Monitoring Board (DSMB) will serve as the central monitoring board for the study. An independent medical monitor from the Weill Cornell Medicine DSMB will review cumulative study data twice a year to evaluate safety, efficacy, study conduct, and scientific validity and integrity of the study. This study will be conducted in accordance with the guidelines in the 2001 National Cancer Institute-approved data and safety monitoring plan for the Weill Cornell Medicine Meyer Cancer Center. Reports to the DSMB will include information regarding accruals, targets, responses, AEs, and evidence of reporting to appropriate review committees. Safety reports will be submitted to the DSMB every 6 months for review. The Weill Cornell Medicine DSMB will review the IRB-approved protocol, the data and safety monitoring plan and any stopping guidelines during protocol initiation. The study protocol is approved by the IRB of Weill Cornell Medicine and all methods in this study are conducted in accordance with IRB guidelines, rules, and regulations.