Protocol Specific Research Support

CCSG的议定书特定研究支持(PSRS)资金支持研究人员 致力于开发、实施、实施和完成高优先级、创新性的 研究人员启动的I期临床试验。这个资源对癌症中心来说是高度优先的，因为 重新坚定地致力于转化性研究和早期临床研究。特别是，这一点 资金机制对于YCC完成其将最令人兴奋的发现和 来自YCC研究实验室的科学进入临床环境。因此，这些类型的翻译性临床 研究在性质和设计上是复杂的，因为它们包括重要的相关的、生物学的、 药代动力学和药效学研究。虽然YCC PSR一直支持调查人员发起 研究表明，PSRS预计研究人员发起的临床试验将在 在下一个供资期间，需要更多地支持这些调查人员。PSR的主要目标是 (1)为研究人员发起的第一阶段临床试验提供护理和数据管理支持；(2) 协助调查人员开发和启动创新研究；(3)提供 协助确定这些临床研究的资格和招募患者，(4)确保安全 通过监测患者进行临床研究，(5)提供原始文件，以便及时和 (6)报告研究结果，(7)确保符合联邦和监管规定 委托书。这项工作将需要有经验的研究护士和数据经理来确保 这些重要研究的安全性、完整性和成功。人员配备的连续性是成功的关键 目前正在进行的研究和将在下一个资助期开发的研究。PSR 与YCC临床试验计划的其他关键要素密切互动，其中包括临床 研究服务(CRS)和礼宾审查和监测系统(PRMS)，并在 综合、高度协调的这三个要素是YCC临床的基石 除了调查计划，PSRS还与YCC临床/转译研究密切互动 计划，包括发育治疗(DT)、放射生物学和放射治疗(R&R)，以及 免疫学与免疫疗法(L、L)。皮肤癌中的孢子，特别是黑色素瘤 展示了DT、L和L与癌症之间高度跨学科、跨计划的合作 预防和控制计划，并强调重点开发创新的临床研究，以防止 直接来自YCC的临床前实验室调查。

The Protocol Specific Research Support (PSRS) funding of the CCSG supports research personnel dedicated to the development, implementation, conduct, and completion of high priority, innovative investigator-initiated phase I clinical trials. This resource is of high priority to the Cancer Center given the renewed and strong commitment to translational research and early phase clinical studies. In particular, this funding mechanism is critical for the YCC to fulfill its mission of translating the most exciting discoveries and science coming from YCC research labs into the clinical setting. As such, these types of translational clinical studies are complex in nature and design, as they incorporate important correlative, biologic, pharmacokinetic, and pharmacodynamic studies. While the YCC PSRS has always supported investigatorinitiated studies, the PSRS anticipates a significant increase in investigator-initiated clinical trials during the next funding period with an increased need to support these investigators. The main goals of the PSRS are to (1) provide nursing and data management support for investigator-initiated pilot phase I clinical studies, (2) provide assistance to investigators in the development and start-up of innovative studies, (3) provide assistance in eligibility determination and recruitment of patients for these clinical studies, (4) ensure the safe conduct of clinical research by monitoring patients, (5) provide source documentation for timely and complete entry in the PRS, (6) report study results, and (7) ensure compliance with federal and regulatory mandates. This effort .will require research nurses and data managers who have experience to ensure the safety, integrity, and success of these important studies. The continuity of staffing is essential to the success of studies presently on-going and to those that will be developed in the next funding period. The PSR interacts closely with the other key elements of the YCC clinical trials program, which include the Clinical Research Services (CRS) and the Protocol Review and Monitoring System (PRMS), and working together in an integrated, highly coordinated manner, these 3 elements serve as the cornerstone for the YCC clinical investigations program, The PSRS also interacts closely with the YCC Clinical/Translational Research Programs, including Developmental Therapeutics (DT), Radiobiology & Radiotherapy (R&R), and Immunology & Immunotherapy (l&l). The SPORE in Skin Cancer with a special focus on melanoma showcases the highly interdisciplinary, interprogrammatic collaborations between the DT, l&l, and Cancer Prevention and Control Programs and highlights the focus on developing innovative clinical studies that stem directly from YCC pre-clinical laboratory investigation.