Data Coordinating Center for Organ Transplant Clinical *

描述(由申请人提供)：PPD，Inc.提议成为由NIAID资助的儿科移植合作临床试验(CCTPT)和器官移植临床试验(CTOT)临床试验网络的统计和临床协调中心(SACCC)，以进行器官移植研究。PPD团队在与政府和制药合作伙伴密切合作方面拥有丰富的经验，管理执行临床研究所需的所有方面，从新的统计方法到方案开发，到IND提交，以研究产品分布，再到全面的不良事件报告。 凭借PPD作为NIAID资助的免疫耐受网络(ITN)协调中心的经验，该团队对进行移植研究的内在复杂性和挑战以及与NIAID工作人员在管理协作临床研究方面的具体经验有着深刻的洞察。该项目的具体目标是提供高质量的资源和程序，以支持：1)临床试验设计、实施和管理，包括根据ICH和GCP指南，为临床试验的统计设计、分析和管理、临床现场监测以及现场临床、技术和数据管理人员培训制定和实施计划和标准操作程序；2)制定方案，包括创建和修改临床方案、病例报告表、标准同意书和程序手册；3)法规遵从性，包括准备新药研究申请，向FDA提交中期和年度报告，跟踪新药申请，并向所有新药赞助商提供数据；4)计算机化数据和通信系统，包括创建和维护安全和保密的临床数据收集和管理系统、连接临床站点和SACCC的电子系统、临床站点注册系统以及接收、跟踪、报告和处置不良事件的系统；5)提供具体的后勤服务，包括研究药物的包装、分发和跟踪，以及项目协议所要求的样本的收集和跟踪；6)编写报告和分析，包括向CCTPT-CTOT赞助方提交的例行报告、用于科学陈述的报告以及在科学期刊上发表的报告；以及7)协调指导委员会的会议以及CCTPT和CTOT网络的调查员会议。SACCC将执行、管理和促进这一项目，以支持NIAID的议程，并与NIAID科学协调员密切互动。

DESCRIPTION (provided by applicant): PPD, Inc. proposes to be the Statistical and Clinical Coordinating Center (SACCC) for the Cooperative Clinical Trials in Pediatric Transplantation (CCTPT) and Clinical Trials in Organ Transplantation (CTOT) clinical trials networks funded by NIAID to conduct organ transplant studies. The PPD team has extensive experience in working closely with both government and pharmaceutical partners in managing all facets necessary for the execution of clinical research ranging from novel statistical approaches to protocol development to IND submissions to study product distribution to comprehensive adverse event reporting. With PPD's experience as the coordinating center for the NIAID-funded Immune Tolerance Network (ITN), the team has great insight into the inherent complexities and challenges in conducting transplantation research and specific experience collaborating with NIAID staff in the management of collaborative clinical research. The specific aims of this project are to provide high quality resources and procedures in support of: 1) Clinical trial design, implementation and management, including the development and implementation of plans and standard operating procedures for the statistical design, analysis and management of clinical trials, monitoring of clinical sites, and training of site clinical, technical and data management staff, according to ICH and GCP guidelines; 2) Protocol development, including the creation and modification of clinical protocols, case report forms, standard consent forms and Manuals of Procedures (MOPs); 3) Regulatory compliance, including preparation of Investigational New Drug (IND) Applications, interim and annual reports to the FDA, tracking of IND applications, and provision of data to all IND sponsors; 4) Computerized data and communication systems, including the creation and maintenance of secure and confidential clinical data collection and management systems, electronic systems to link clinical sites and the SACCC, clinical site registration systems, and systems for the receipt, follow-up, reporting and disposition of adverse events; 5) Provision of specified logistical services, including, packaging, distribution and tracking of study medications and collection and tracking of specimens required by project protocols; 6) Preparation of reports and analyses, including routine reports to CCTPT-CTOT sponsors, reports used for scientific presentations, and publications in scientific journals; and 7) Coordination of meetings of the Steering Committees and of investigators for the CCTPT and CTOT networks. The SACCC will administer, manage and facilitate this program in support of the NIAID agenda, interacting closely with the NIAID Scientific Coordinator.