The Dan L Duncan Cancer Center (DLDCC) places the highest priority on ensuring the safety of patients participating in clinical trials. The Principal Investigator (PI) has primary responsibility for oversight, but additional safety measures include integrated scientific, safety and ethical review and monitoring coupled with quality assurance audits. The primary oversight of clinical research conducted at DLDCC as related to the Initiation, monitoring and termination of clinical trials Is overseen by (1) the Protocol Review and Monitoring Committee (PRMC), (2) Data Review Committees (DRC);and (3) a Patient Safety Officer (PSO) who ensures that all data monitoring for Cancer Center trials is conducted in accordance with the approved monitoring plan. Each DLDCC protocol must have a data and safety monitoring plan, which is reviewed and approved by the PRMC prior to patient enrollment. Protocol monitoring for DLDCC protocols may be accomplished by several mechanisms Including: NCI Cooperative Group data and safety review committees, medical monitors or committees established by a pharmaceutical or academic sponsor, DLDCC standing Data Review Committees or by individual, protocol-specific Data and Safety Monitoring Boards. The committees, and the PSO, report to the Clinical Research Leadership Committee within the DLDCC and ultimately to the Cancer Center Director.
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