Dental Practice-Based Research Network Coordinating Ctr

描述（由申请人提供）：本申请是对RFA-DE-05-006中关于基于牙科实践的研究网络的响应，是一项作为RFA中基于实践的研究网络（PBRN）的协调中心（CC）的申请。与拟议的网络主席一起，我们成立了“牙科PBRN”，其中包括来自美国六个州和斯堪的纳维亚半岛的牙医。我们有一个独特的机会，建立在全州牙科PBRN在亚拉巴马已经有一个NIH资助的R 01临床试验和一个NIH资助的R21研究正在进行中;和经验，从大型横截面和纵向牙科实践为基础的研究在佛罗里达，明尼苏达州，太平洋西北部和斯堪的纳维亚半岛。我们的申请最好被看作是CC和网络主席的联合响应，这两个小组必须作为一个完全集成的实体工作。牙科PBRN的主要科学目标是：（1）加速临床研究的发展和实施;（2）进行相对短期的研究，以比较预防和治疗方法的有效性;以及（3）加强临床决策的知识基础。次要目标是：（1）进行匿名病历审查;（2）提供治疗趋势数据;（3）估计不常见疾病的患病率。牙科PBRN组织结构包括牙科实践，网络主席行政结构，CC，执行委员会，方案审查委员会，数据和安全监测委员会，观察性研究监测委员会和NIDCR工作人员。我们将协助网络主席和执行委员会选择参与特定研究的从业者，并组织方案制定、培训程序和材料并举办培训课程。我们还将建立和运行适当的质量保证计划，评估和监控从业人员的绩效和其他关键运营活动。我们将采用适当的技术进行数据收集、数据管理以及研究分析和出版问题。我们将建立安全性和数据管理委员会以及观察性研究监查委员会，以进行安全性和伦理审查，并将对研究方案进行IRB批准。这将包括创建和维护一个数据库，记录同意过程和其中包含的任何层。

DESCRIPTION (provided by applicant): This application responds to RFA-DE-05-006 for a General Dental Practice-Based Research Network, and is an application to serve as the Coordinating Center (CC) for the Practice-Based Research Network (PBRN) in the RFA. In conjunction with the proposed Network Chair, we have formed the "Dental PBRN" that includes dentists from six US states and Scandinavia. We have a unique opportunity to build upon a statewide dental PBRN in Alabama which already has one NIH-funded R01 clinical trial and one NIH-funded R21 study in progress; and experience from large cross-sectional and longitudinal dental practice-based studies in Florida, Minnesota, the Pacific Northwest, and Scandinavia. Our application is best viewed as a joint response from the CC and the Network Chair-both groups must work as a fully-integrated entity. The Dental PBRN's primary scientific aims are to: (1) accelerate development and conduct of clinical research; (2) perform relatively short-term studies to compare effectiveness of preventive and treatment methods; and (3) strengthen the knowledge base for clinical decision making. Secondary aims are to: (1) conduct anonymous chart reviews; (2) provide data on treatment trends; and (3) estimate prevalence of less-common conditions. The Dental PBRN organizational structure comprises dental practices, the Network Chair administrative structure, the CC, the Executive Committee, the Protocol Review Committee, the Data & Safety Monitoring Board, the Observational Studies Monitoring Board, and NIDCR staff. We will assist the Network Chair and the Executive Committee to select practitioners to participate in specific studies and will organize protocol development, training procedures and materials and conduct training sessions. We will also establish and operate appropriate quality assurance programs assessing and monitoring practitioner performance and other key operational activities. We will adapt appropriate technology for data collection, data management and study analytical and publication issues. We will establish Safety and Data Management Boards and Observational Study Monitoring Boards for safety and ethical overview and will operate the IRB approval process for study protocols. This will include the creation and maintenance of a database documenting the consent process and any layers contained there.