NIDDK OCRS Clinical Consortium Audit Support

一个国家糖尿病、消化和肾脏疾病研究所（NIDDK）外部资助的联盟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。对参与者的长期健康结果进行跟踪，每年进行两次访问。最初的临床试验是在美国食品和药物管理局（FDA）的新药研究（IND）下进行的。IND在随访期间被撤回，然后在研究药物供应商更改为未经过FDA检查的供应商时，在此期间晚些时候实施了新的IND。NIDDK最近了解到，一个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（良好临床实践）GCP指南的问题。NIDDK领导和临床研究支持办公室（OCRS）人员与外部工作人员和NIH相关办公室进行了磋商，然后决定进行独立的“原因”评估，以解决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 The IND was withdrawn during the follow-up period, and then a new IND put in place later during that period when the study drug supplier was changed to a supplier that had not been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.