NIDDK OCRS Clinical Consortium Audit Support

国家糖尿病、消化和肾脏疾病研究所(NIDDK)外部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调查，并每年进行两次访问。最初的临床试验是在食品和药物管理局(FDA)的研究新药(IND)下进行的。在后续期间，IND被撤回，然后在研究药物供应商被更换为未经FDA检查的供应商期间，随后建立了新的IND。NIDDK最近获悉，其中一个临床中心的机构审查委员会(IRB)发现了与联邦法规和(良好临床实践)GCP指南相关的潜在问题。NIDDK领导层和临床研究支持办公室(OCRS)的人员咨询了外部工作人员和NIH的相关办公室，然后决定应该进行独立的原因评估，以确定资助者和赞助者的责任。

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 The IND was withdrawn during the follow-up period, and then a new IND put in place later during that period when the study drug supplier was changed to a supplier that had not been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.