Data Coordinating Center for Organ Transplant Clinical *

器官移植临床数据协调中心*

基本信息

批准号：
7905233
负责人：
JUN LIU
金额：
$ 75万
依托单位：
PPD DEVELOPMENT LP
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-01 至 2010-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7905233
关键词：
Adverse event Annual Reports Case Report Form Childhood Clinical Clinical Data Clinical Protocols Clinical Research Clinical Trials Clinical Trials Design Clinical Trials Network Collection Communication Consent Forms Data Data Collection Data Coordinating Center Development Electronics Funding Government Guidelines Immune Tolerance Investigational Drugs Investigational New Drug Application Journals Link Maintenance Manuals Modification Monitoring Clinical Trials National Institute of Allergy and Infectious Disease Observational Study Organ Organ Transplantation Pharmaceutical Preparations Pharmacologic Substance Preparation Procedures Protocols documentation Publications Reporting Research Research Personnel Resources Secure Services Solid Specific qualifier value Specimen Study Subject System Training Transplantation Work clinical research site computerized data management design experience follow-up insight meetings novel programs protocol development statistical center

项目摘要

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.

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 (CCPTT) 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，从新颖的统计方法到方案开发，到 IND 提交，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固有复杂性和挑战有着深刻的洞察力，并且在与 NIAID 工作人员合作管理协作临床研究方面拥有具体的经验。该项目的具体目标是提供高质量的资源和程序来支持： 1）临床试验设计、实施和管理，包括临床试验统计设计、分析和管理的计划和标准操作程序的制定和实施根据 ICH 和 GCP 指南，监测临床中心，并对临床中心、技术和数据管理人员进行培训； 2) 方案制定，包括临床方案、病例报告表、标准同意书和程序手册（MOP）的创建和修改； 3) 监管合规性，包括准备研究性新药 (IND) 申请、向 FDA 提交的中期和年度报告、跟踪 IND 申请以及向所有 IND 申办者提供数据； 4) 计算机化数据和通信系统，包括创建和维护安全保密的临床数据收集和管理系统、连接临床中心和 SACCC 的电子系统、临床中心注册系统以及接收、跟踪、报告系统以及不良事件的处置； 5) 提供指定的后勤服务，包括研究药物的包装、分发和跟踪以及项目方案要求的标本采集和跟踪； 6) 准备报告和分析，包括向 CCTPT-CTOT 申办者提供的例行报告、用于科学演示的报告以及在科学期刊上发表的文章； 7) 协调 CCTPT 和 CTOT 网络的指导委员会会议和调查员会议。 SACCC 将管理、管理和促进该计划，以支持 NIAID 议程，并与 NIAID 科学协调员密切互动。