Coordinating Center for Infant Aphakia Treatment Study

婴儿无晶体眼治疗研究协调中心

• 批准号: 8293268
• 负责人: MICHAEL J LYNN
• 金额: $ 75.91万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-06-01 至 2013-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8293268
• 关键词: Adherence; Adverse event; Aphakia; Applications Grants; Case Report Form; Chairperson; Clinical; Clinical Investigator; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Collection; Confidentiality; Confidentiality of Patient Information; Contact Lenses; Data; Data Coordinating Center; Data Reporting; Eligibility Determination; Epidemiology; Experimental Designs; Future; Hour; Human Resources; Infant; Interview; Intraocular lens implant device; Location; Mails; Monitor; Operating Rooms; Outcome; Parenting behavior; Parents; Patients; Pilot Projects; Principal Investigator; Procedures; Process; Protocols documentation; Published Comment; Randomized; Reporting; Research Design; Research Personnel; Resources; Safety; Sample Size; Schedule; Screening procedure; Sleep; Stress; Techniques; Testing; Training; Visit; Visual Acuity; Work; compliance behavior; congenital cataract; data acquisition; data management; design; diaries; follow-up; primary outcome; programs; response; seal; secondary outcome

DESCRIPTION (provided by applicant): The purpose of the Data Coordinating Center (DCC) for the Infant Aphakia Treatment Study (IATS) is to provide design and trial management support for this randomized multicenter clinical trial. In particular, the DCC will be responsible for the following activities: (1) Research Design: The DCC will provide statistical and epidemiological expertise in the design of the study. This includes defining outcomes, choosing the experimental design, estimating sample size and power, determining procedures to control bias, and evaluating the potential impact from any future proposed changes to the study design or procedures. (2) Case Report Forms: The DCC will collaborate with the clinical investigators to design the case report forms. The DCC will produce the case report forms and distribute the forms to the clinical centers. (3) Training: The DCC will train and certify clinical center personnel in non-clinical study procedures. (4) Patient Screening and Randomization: The DCC will design and implement patient screening and randomization procedures. (5) Data Management: The DCC will be responsible for all aspects of data management including data acquisition from the clinical centers, data editing for accuracy and completeness, monitoring completeness of follow-up and contacting centers to correct data problems. (6) Coordination with Visual Acuity Testing Center (VATC): The DCC will coordinate with the VATC on the collection and processing of the visual acuity data. (7) Clinical Center Monitoring: The DCC will conduct auditing visits to the clinical centers to verify the data submitted on CRFs and to check that the protocol is being followed. (8) Patient Tracking: The DCC will assist the clinical centers in tracking the location of patients. (9) Patient Adherence Monitoring: The DCC will place calls to the patients to monitor adherence to the patching protocols. (10) Adverse Event Monitoring: The DCC will monitor the occurrence of adverse events and will report to the Data Safety Monitoring Committee (DSMC) on a regular schedule. (11) Statistical Reporting and Analysis: The DCC will develop statistical reports for the DSMC and other agencies and will determine and carry out appropriate statistical analyses to evaluate study hypotheses.

描述（由申请人提供）：婴儿阿法基亚治疗研究（IAT）的数据协调中心（DCC）的目的是为这项随机多中心临床试验提供设计和试验管理支持。 特别是，DCC将负责以下活动：（1）研究设计：DCC将在研究设计中提供统计和流行病学专业知识。 这包括定义结果，选择实验设计，估计样本量和功率，确定控制偏见的程序，并评估未来对研究设计或程序的任何未来提议的更改的潜在影响。 （2）案例报告表：DCC将与临床研究人员合作设计案例报告表。 DCC将制作案例报告并将表格分配给临床中心。 （3）培训：DCC将在非临床研究程序中培训和认证临床中心人员。 （4）患者筛查和随机分组：DCC将设计和实施患者筛查和随机程序。 （5）数据管理：DCC将负责数据管理的各个方面，包括从临床中心获取数据，数据编辑的准确性和完整性，监视随访的完整性和接触中心以纠正数据问题。 （6）与视敏度测试中心（VATC）的协调：DCC将与VATC协调视力数据的收集和处理。 （7）临床中心监测：DCC将对临床中心进行审计访问，以验证CRF上提交的数据并检查是否遵循该协议。 （8）患者跟踪：DCC将帮助临床中心跟踪患者的位置。 （9）患者依从性监测：DCC将对患者进行呼叫，以监视对修补方案的依从性。 （10）不良事件监控：DCC将监视不良事件的发生，并会定期向数据安全监控委员会（DSMC）报告。 （11）统计报告和分析：DCC将为DSMC和其他机构开发统计报告，并将确定并进行适当的统计分析以评估研究假设。