Timing of Primary Surgery for Cleft Palate

描述（由申请人提供）：孤立性腭裂是最常见的颅面出生异常（例如，在美国，每10,000个新生儿中有4.5个）。它会造成进食、语言、听力和牙齿发育方面的问题。手术可能无法解决这些问题，并降低儿童社会发展和融入的潜力。“腭裂初级手术时机”试验的目的是调查腭裂手术时机对语言结果的影响，数据协调中心（DCC）将通过提供行政，后勤和生物统计支持试验活动，以制定，实施和成功完成试验方案。为了实现这一目标，DCC将：1)积极参与试验范围内的委员会；2)管理开展国际研究所需的信息系统，使用安全的研究特定门户网站，以促进随机化、数据输入以及DCC和现场协调员之间的沟通；3)协调整体学习活动，包括安排会议和电话会议，记录和分发会议记录，准备学习资料；4)安排并持续对研究人员进行数据收集、数据录入和试验监测方面的培训；5)与管理站点合作，进行中央监测和年度现场访问，以监测站点是否遵守《良好临床操作规范》指南；6)监督现场数据采集和录入的招募和及时性，并对所有研究数据实施质量保证程序；7)跟踪语音、临床、遗传和听力学数据的收集和转移，准备和监督最终（“锁定”）研究数据的分发；8)在整个研究过程中提供统计专业知识，包括监测随机化程序，向数据和安全监测委员会编写报告，执行统计分析计划，分析最终研究数据；9)为出版物准备稿件，传播研究成果；10)准备一个公共网页，提供有关试验结果的信息（通俗地说）；11)将所有相关源文件存档，以便在试验结束后（如接受主管部门检查时）与源数据进行比较。项目说明：改善腭裂手术的证据基础将改善腭裂患儿的治疗和社会融合，减轻患儿及其家庭必须承受的补救护理负担，并降低腭裂相关的护理成本。

DESCRIPTION (provided by applicant): Isolated cleft palate is the commonest craniofacial birth anomaly (e.g., 4.5 per 10,000 births in the US). It creates problems in feeding, speech, hearing, and dental development. Surgery may fail to resolve these problems and reduce the child's potential for social development and inclusion. The purpose of the "Timing of Primary Surgery for Cleft Palate" trial is to investigate the influence of the timing of cleft palate surgery on speech outcomes and the Data Coordinating Center (DCC) will support the activities of the trial with the provision of administrative, logistical, and biostatistical support for the development, implementation, and successful completion of the trial protocol. To accomplish this objective, the DCC will: 1) actively participate on trial-wide committees; 2) manage the information systems required to conduct an international study utilizing a secure study-specific web portal to facilitate randomization, data entry, and communication between the DCC and site coordinators; 3) coordinate overall study activities, including scheduling meetings and conference calls, recording and distributing minutes, and preparing study materials; 4) arrange for and conduct ongoing training of study staff with respect to data collection, data entry, and trial monitoring; 5) conduct central monitoring and conduct yearly site visits, in partnership with the administrative site, to monitor site compliance with Good Clinical Practice guidelines; 6) monitor recruitment and timeliness of data acquisition and data entry at sites and carry out quality assurance procedures on all study data; 7) track the collection and transfer, of speech, clinical, genetic and audiological data and prepare and oversee distribution of the final ("locked") study data; 8) provide statistical expertise throughout the study to include monitoring of the randomization routine, preparation of reports to the Data and Safety Monitoring Board and execute the statistical analysis plan for analysis of final study data; 9) prepare manuscripts for publications to disseminate study findings; 10) prepare a public web page to provide information (in lay terms) regarding trial findings; and 11) archiving of all relevant source documents so that the trial data can be compared against source data after completion of the trial (e.g. in case of inspection from authorities). Project Narrative: Improving the evidence base for cleft palate surgery will improve the treatment and social integration of affected children, reduce the burden of remedial care that they and their families must endure, and reduce the cost of care associated with cleft palate.