National Institute of Arthritis and Musculoskeletal and Skin Diseases Clinical Studies Management and Support

国家关节炎、肌肉骨骼和皮肤疾病研究所临床研究管理和支持

• 批准号: 9553427
• 负责人: KATHY DIMEO
• 金额: $ 166.79万
• 依托单位: KAI RESEARCH, INC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9553427
• 关键词: Adherence; Arthritis; Biometry; Clinical Research; Clinical Trials; Consultations; Contracts; Data; Data Quality; Development; Ensure; Funding; Good Clinical Practice; Guidelines; Institutes; Logistics; Monitor; Musculoskeletal Diseases; National Institute of Arthritis and Musculoskeletal and Skin Diseases; Policies; Research Personnel; Safety; Services; Support Contracts; System; Training; clinical research site; meetings; operation; research study; skin disorder

The Assessments and Assistance for National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Clinical Studies contract supports the NIAMS with the oversight and management of its clinical research studies and clinical trials. This contract supports clinical trials and clinical research in arthritis and musculoskeletal and skin diseases. The services will include the necessary operations needed to execute clinical research studies and clinical trials from study inception to completion. Examples of these services include but are not limited to; clinical study document development and review; data and safety monitoring committee management and support; logistical and executive secretarial support for meetings; clinical site monitoring and study assessment; biostatistical review and consultation; regulatory support and consultation; Good Clinical Practice training for NIAMS staff and Investigators; and the development of electronic systems for managing clinical study information/data. The executive secretarial/logistical functions for the management of committees providing data and safety monitoring oversight to NIAMS funded clinical studies and clinical trials. In addition, this contract effort provides assistance with the conduct of clinical research to ensure data quality and adherence to good clinical practice, and Federal guidelines and policies.

国家关节炎、肌肉骨骼和皮肤疾病研究所（NIAMS）临床研究评估和援助合同支持NIAMS的临床研究和临床试验的监督和管理。该合同支持关节炎、肌肉骨骼和皮肤疾病的临床试验和临床研究。这些服务将包括从研究开始到完成执行临床研究和临床试验所需的必要操作。这些服务的示例包括但不限于：临床研究文件的开发和审查；数据和安全监测委员会的管理和支持；为会议提供后勤和执行秘书支助；临床现场监测和研究评估；生物统计审查和咨询；监管支持和咨询；对NIAMS员工和调查员进行良好临床操作规范培训；以及用于管理临床研究信息/数据的电子系统的开发。执行秘书/后勤职能，负责管理为NIAMS资助的临床研究和临床试验提供数据和安全监测监督的委员会。此外，该合同还为临床研究的开展提供协助，以确保数据质量并遵守良好的临床实践和联邦指导方针和政策。