PROTOCOL REVIEW AND MONITORING SYSTEM

为了帮助确保最高水平的患者安全和研究质量，癌症治疗和研究 德克萨斯大学圣安东尼奥健康科学中心(UTHSCSA)协议 评审委员会(中华人民共和国)负责科学和技术委员会的内部监督。 UTHSCSA的CTRC的所有癌症临床试验的研究方面。中华人民共和国帮助确保 癌症中心的共享资源得到适当利用，以促进尽可能好的研究进行 并最大限度地提高癌症中心的整体科学生产率。PRC的主要职能是 审查所有研究的科学价值，以确保根据P30科学优先顺序对方案进行优先排序， 并监测所有与癌症相关的预防和治疗临床研究方案的研究进展。 中华人民共和国主席向P30副主任报告。P30研究管理办公室(ORA) 是癌症中心的共享资源，为中国提供支持。中华人民共和国的职能是 作为UTHSCSA国际审查委员会(IRB)的补充，IRB的重点是保护 人类受试者。中华人民共和国确定的所有规定必须在提交IRB之前解决。中华人民共和国 职能部门不与IRB的职责重复或重叠，PRC也不履行 由ORA和DATA在CTRC内执行的审计或数据和安全监测职能 安全与监测委员会(DSMC)。预审和学习由中华人民共和国负责。 继续开展与科学研究领域有关的活动。所有与癌症相关的研究都涉及使用 人体受试者在提交给UTHSCSA IRB之前，需要得到本中华人民共和国的初步批准。中华人民共和国 有权开放方案(经IRB批准)，以证明科学价值并满足 P30的优先事项。中华人民共和国可以关闭没有显示出足够的科学进步或收益的方案。 在联合过程中，所有研究在初始审查时都被分配了审计级别分数(PALS)的优先级 在中华人民共和国和dsmc之间。数据安全官(DSO)，他同时是中华人民共和国和 Dsmc负责协调这一过程。然后，DSO将研究伙伴输入IDEAS数据库。这 分数被用来确定试验被DSO和审计团队审计的总体可能性。 与IRB的批准一样，中华人民共和国对议定书的批准是允许履行 反恐委员会在UTHSCSA的附属机构内与癌症有关的议定书，网址为 UTHSCSA。

To help ensure the highest level of patient safety and research quality, the Cancer Therapy and Research Center (CTRC) at The University of Texas Health Science Center at San Antonio (UTHSCSA) Protocol Review Committee (PRC) is charged with the responsibility for internal oversight of the scientific and research aspects of all cancer clinical trials at the CTRC at UTHSCSA. The PRC helps to ensure that the Cancer Center's Shared Resources are engaged appropriately to facilitate the best possible study conduct and to maximize the overall scientific productivity of the Cancer Center. The primary PRC function is to review all studies for scienfific merit, to ensure prioritizafion of protocols according to P30 scienfific priorifies, and to monitor study progress for all cancer-related prevenfion and therapeufic clinical research protocols. The Chair of the PRC reports to the P30 Deputy Director. The P30 Office of Research Administrafion (ORA) is a Cancer Center shared resource which provides support to the PRC. The funcfion of the PRC is complementary to that of the UTHSCSA Insfitufional Review Board (IRB), which focuses on the protecfion of human subjects. All stipulafions identified by the PRC must be resolved prior to IRB submission. PRC funcfions do not duplicate or overiap with the responsibilifies of the IRB, nor does the PRC perform either auditing or data and safety monitoring functions which are performed in the CTRC by the ORA and the Data Safety and Monitoring Committee (DSMC) respecfively. The PRC is responsible for pre-acfivation and study continuafion activities related to scientific areas of research. All cancer-related studies involving the use of human subjects require the initial approval of this PRC prior to submission to the UTHSCSA IRB. The PRC has the authority to open protocols (with IRB approval) that demonstrate scientific merit and that meet the priorities of the P30. The PRC can close protocols that do not show sufficient scienfific progress or accrual. All studies, at time of inifial review are assigned a priority of audit level score (PALS) in a joint process between the PRC and DSMC. The Data Safety Officer (DSO), who is a member of both the PRC and DSMC, coordinates this process. A study PALS is then entered into the IDEAS database by the DSO. This score is used to determine the trial's overall likelihood of being audited by the DSO and the audit team. Approval of a protocol by PRC is a fundamental requirement, as is IRB approval, to allow performance of a cancer-related protocol by CTRC at UTHSCSA members within the affiliated institutions of the CTRC at UTHSCSA.