PROTOCOL REVIEW & MONITORING SYSTEMS/SCIENTIFIC REVIEW COMMITTEE

方案审查

• 批准号: 8495982
• 负责人: THOMAS A SELLERS
• 金额: $ 13.86万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8495982
• 关键词: Budgets; Cancer Center; Cancer Center Support Grant; Clinical; Clinical Research; Clinical Research Protocols; Committee Members; Communication; Contracts; Data; Databases; Goals; Home environment; Institutional Review Boards; Laboratories; Monitor; Peer Review; Pharmacy facility; Principal Investigator; Process; Protocols documentation; Research; Research Infrastructure; Research Personnel; Research Proposals; Resources; Review Committee; Safety; System; Tissues; Work; human subject; meetings; member; protocol development; translational clinical trial

The Scientific Review Committees (SRC) provide thorough scientific reviews of all protocols to be activated at the Moffitt Cancer Center. Support of the SRC process is the primary focus of the staff within the Protocol Review and Monitoring (OPRM). Specific goals of the PRMS are: ¿ Appropriate and thorough scientific and statistical review of Moffitt protocols ¿ Efficient processing and accurate tracking of Moffitt clinical research protocols, and ¿ Monitoring of scientific progress for ongoing clinical research trials. OPRM support staff process the documents necessary for the review committees and facilitate timely communication of SRC actions between the committee and investigators. All correspondence is saved electronically and noted within the research database (Oncore¿). Support staff members also assist investigators in the development of protocol-specific data and safety monitoring plans. The OPRM office maintains an accurate protocol-tracking database for use by the regulatory staff, principal investigators, study teams, and committee members to monitor protocol progress through the review processes, including SRC and IRB review, budgeting, and contracting as appropriate, and an operational review process to allow ancillary departments to review and sign off on protocol feasibility. Other OPRM staff members assist Moffitt investigators with efficient, accurate review and processing of research protocols and submission to the IRB for human subject approval and work with monitors in the data and safety monitoring process. Moffitt has committees that perform scientific review, each meeting monthly. Two committees review clinical research proposals, while the third committee reviews tissue and data studies. Meeting dates are staggered to allow for SRC meetings approximately every 10 days. The three SRCs provide the initial scientific peer review of the protocol and monitor these protocols throughout the term of the study for scientific progress (e.g., meeting accrual goals) and for changes that might impact the objectives of the study. The PRMS requests CCSG Support of $247,671, which is 28% of its operational budget.

科学审查委员会（SRC）对所有待启动的方案进行全面的科学审查 在莫菲特癌症中心支持SRC进程是《议定书》工作人员的主要工作重点 审查和监测（OPRM）。PRMS的具体目标是： 对Moffitt方案进行适当和彻底的科学和统计审查 高效处理和准确跟踪Moffitt临床研究方案，以及 监测正在进行的临床研究试验的科学进展。 审查机制办公室的支助人员处理审查委员会所需的文件， 委员会和研究者之间SRC行动的沟通。所有通信都保存 以电子方式并在研究数据库（Oncore）中记录。支助工作人员也提供协助 研究者制定方案特定数据和安全性监测计划。OPRM办公室 维护准确的方案跟踪数据库，供监管人员、主要研究者 研究团队和委员会成员通过审查过程监测方案进展，包括 SRC和IRB审查、预算和合同（如适用），以及运营审查流程， 辅助部门审查并签署方案可行性。其他OPRM工作人员协助Moffitt 研究者高效、准确地审查和处理研究方案并提交给IRB 用于人类受试者批准，并在数据和安全性监测过程中与监查员合作。 莫菲特有委员会进行科学审查，每个月举行一次会议。两个委员会审查临床 第三委员会审查组织和数据研究。会议日期错开 允许SRC会议大约每10天举行一次。三个SRC提供了最初的科学同行 审查方案并在整个研究期间监测这些方案的科学进展 (e.g.,满足应计目标）以及可能影响研究目标的变化。 PRMS要求CCSG提供247，671美元的支持，占其业务预算的28%。