NIDDK OCRS Clinical Consortium Audit Support

NIDDK OCRS 临床联盟审核支持

• 批准号: 10498366
• 负责人: SEUN OYEWO
• 金额: $ 18.52万
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-22 至 2022-03-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10498366
• 关键词: Address; Clinical; Clinical Practice Guideline; Clinical Research; Clinical Trials; Consult; Contractor; Extramural Activities; Funding; Good Clinical Practice; Health; Human Resources; Institution; Institutional Review Boards; Investigational Drugs; Laws; Leadership; Location; Longterm Follow-up; National Institute of Diabetes and Digestive and Kidney Diseases; Outcome; Participant; Pharmaceutical Preparations; Procedures; Protocols documentation; Randomized Clinical Trials; Regulation; Research Support; United States Food and Drug Administration; United States National Institutes of Health; Visit; clinical center; follow-up; non-compliance

A National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) extramurally funded consortium initially conducted a multi-center randomized clinical trial with a Coordinating Center and 20-some clinical centers and then transitioned to a long-term follow-up protocol. Participants are being followed for long-term health outcomes and have two visits each year. The initial clinical trial operated under an Food and Drug Administration (FDA) Investigational New Drug (IND). The IND was withdrawn during the follow-up period, and then a new IND put in place later during that period when the study drug supplier was changed to a supplier that had not been inspected by the FDA. The NIDDK recently learned that an Institutional Review Board (IRB) at one of the clinical centers had identified a potential issue of noncompliance relative to Federal regulations and (Good Clinical Practice) GCP guidelines. NIDDK leadership and Office of Clinical Research Support (OCRS) personnel consulted with extramural staff and relevant NIH offices and then decided that an independent ‘for cause’ assessment to address both funder and sponsor responsibilities should be conducted.

美国国家糖尿病、消化和肾脏疾病研究所（NIDDK）的一个由壁外资助的财团最初与一个协调中心和20多个临床中心进行了一项多中心随机临床试验，然后过渡到长期随访方案。参与者正在接受长期健康结果的跟踪，每年有两次访问。最初的临床试验在美国食品药品监督管理局（FDA）的新药研究（IND）下进行。IND在随访期间被撤回，然后在该期间晚些时候，当研究药物供应商变更为未经FDA检查的供应商时，新的IND被投入使用。NIDDK最近获悉，其中一家临床中心的机构审查委员会（IRB）发现了一个潜在的不符合联邦法规和（药物临床试验质量管理规范）GCP指南的问题。NIDDK领导层和临床研究支持办公室（OCRS）工作人员与校外工作人员和相关NIH办公室进行了协商，然后决定进行独立的“有因”评估，以解决资助者和申办者的责任。