IGF::OT::IGF - MULTI-ETHNIC STUDY OF ATHEROSCLEROSIS (MESA)III- COORDINATING CENTER

IGF::OT::IGF - 动脉粥样硬化多种族研究 (MESA)III- 协调中心

• 批准号: 9264644
• 负责人: ROBYN MCCLELLAND
• 金额: $ 453.29万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-01-01 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9264644
• 关键词: Area; Atherosclerosis; Blood specimen; Budgets; Clinic; Clinical; Consent; Data; Data Collection; Data Set; Development; Health Personnel; Informed Consent; Institutional Review Boards; Manuals; Office Management; Participant; Performance; Preparation; Process; Protocols documentation; Qualifying; Quality Control; Research; Research Personnel; Review Committee; Shipping; Ships; Specimen; Test Result; Testing; Training; base; clinically relevant; clinically significant; cohort; operation; protocol development; quality assurance; repository

The purpose of this requirement is to support the recruitment and performance of a limited re-examination of all surviving and willing MESA participants for Exam 6. The targeted recruitment is approximately 4,200 participants. This Task Area will be broken down into two areas, (1) exam preparation activities and (2) the exam and exam closeout activities. Exam preparation activities include providing qualified staff to plan and prepare for Exam 6 at each of the MESA Field Centers; protocol development for the re-examination of the MESA cohort; development of an exam manual of operations, a standardized informed consent template, and an Office of Management and Budget (OMB) submission package if required by the OMB Clinical Exemption Review Committee; planning and conducting of central training for clinic staff; pilot testing for the examination including collecting and shipping blood samples to the bio specimen repository; redesigning and implementing changes to the protocol and manual of operations as recommended by the Operations Committee and approved by the Steering Committee based on pilot testing results; and the acquisition of IRB approvals to conduct the study.

这项要求的目的是支持对所有幸存的和愿意参加考试6的MESA参与者进行有限的复试，以支持征聘和考绩。目标招聘人数约为4 200人。该任务区将分为两个区域，(1)考试准备活动和(2)考试和考试收尾活动。 考试准备活动包括在每个MESA外地中心提供合格的工作人员来规划和准备考试6；为MESA队列的复查制定规程；编写考试操作手册、标准化知情同意模板以及管理和预算局临床豁免审查委员会要求的提交资料包；规划和开展对诊所工作人员的中央培训；对考试进行试点测试，包括收集血液样本并将其运送到生物标本储存库；按照业务委员会的建议并根据试点测试结果重新设计和实施对规程和操作手册的修改；以及获得IRB的批准进行这项研究。