Protocol Review and Monitoring

方案审查和监控

• 批准号: 7944595
• 负责人: STEVEN P STRATTON
• 金额: $ 7.56万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-19 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7944595
• 关键词: Arizona; Authorization documentation; Basic Science; Behavioral; Cancer Center; Cancer Center Support Grant; Caring; Chairperson; Clinical; Clinical Research; Consent; Diagnostic; Discipline; Ensure; Faculty; Grant; Gynecologic Oncology; Hematology; Laboratories; Malignant Neoplasms; Medical; Monitor; Nature; Patients; Pediatric Hematology/Oncology; Peer Review; Performance; Protocols documentation; Records; Research; Research Ethics Committees; Research Personnel; Resource Sharing; Review Committee; Sampling; Services; Surgical Oncology; System; Therapeutic; Translational Research; Treatment Protocols; United States National Institutes of Health; Universities; Writing; base; cancer chemoprevention; cancer therapy; design; member; oncology; population based; research study

9.2 Protocol Review and Monitoring System (PRMS) The Protocol Review and Monitoring System at the Arizona Cancer Center facilitates the our Scientific Review Committee (SRC), which is staffed with appropriate faculty and scientific representation in all disiciplines, to include but not be limited to medical hematology/oncology, surgical oncology, gynecologic oncology, radiafion oncology, pediatric hematology/oncology. Other medical subspecialities, cancer chemoprevention, and, translationals studies with clinical and basic science collaborators are also covered. The primary responsibilities of the AZCC SRC include the following: ¿ Review of all new hypothesis-generated interventional protocols of diagnostic or therapeutic nature as well as longitudinal population-based studies involving patients, patient samples, or patient records conducted by AZCC members to ensure the highest scientific quality of clinical research in advance of IRB submission. ¿ Review ongoing progress of protocols conducted by AZCC members to maximize scientific validity, assure timely and effective performance. - ¿ Evaluate the merit of eligible protocols for utilization of AZCC shared resources/services based upon objective scientific review. ¿ Promote unified standards for protocol implementation and translational research among AZCC investigators of various disciplines involved in cancer treatment and care. Regardless of the protocol type, no clinical research study eligible for SRC review can be submitted to the institutional IRB until SRC approval is granted. SRC actions and approval will accompany IRB submissions. In exceptional circumstances, concurrent IRB review may be allowed with written permission from the SRC Chairman.

9.2 方案审查和监测系统（PRMS） 亚利桑那州癌症中心的方案审查和监测系统促进了我们的科学审查 委员会（SRC），配备了所有学科的适当教职人员和科学代表，以 包括但不限于医学血液学/肿瘤学、外科肿瘤学、妇科肿瘤学、放射学 肿瘤学、儿科血液学/肿瘤学。其他医学亚专业、癌症化学预防，以及， 还包括与临床和基础科学合作者的转化研究。 AZCC SRC 的主要职责包括： ¿ 审查所有新的假设生成的诊断或治疗性质的介入方案 以及涉及患者、患者样本或患者记录的基于人群的纵向研究 由 AZCC 成员进行，以确保临床研究的最高科学质量 IRB 提交。 ¿ 审查 AZCC 成员进行的方案的持续进展，以最大限度地提高科学有效性， 确保及时有效的执行。 - ¿ 评估使用 AZCC 共享资源/服务的合格协议的优点 客观科学的审查。 ¿ 促进 AZCC 之间协议实施和转化研究的统一标准 参与癌症治疗和护理的各个学科的研究人员。 无论何种方案类型，任何符合 SRC 审查资格的临床研究都不能提交给 SRC。 机构 IRB 直至获得 SRC 批准。 SRC 行动和批准将伴随 IRB 提交。在 特殊情况下，经 SRC 书面许可，可允许同时进行 IRB 审查 主席。