立即博立即博Investigator-initiated trials (IITs) provide an innovative pathway for scientific
advancements that 奥古斯塔大学 strives to support. The 研究 Integrity &
Security Monitoring Service was created to proactively provide risk-based oversight
for IITs, and other human research studies, as a method for building a robust network
of institutional and investigational compliance.
研究诚信与安全监控服务旨在：
Monitoring reviews will be implemented routinely throughout the course of human research studies at 奥古斯塔大学, with the highest priority being given to IITs, particularly those without independent monitors. For FDA-regulated trials, monitoring will often begin once the first subject is enrolled.
This program is complimentary to and does not replace the essential roles of AU’s Human 研究 Protection Program or the 院校检讨委员会 (IRB) of record for your study. Furthermore, these reviews are not intended to replace standard quality assurance reviews by the PI and their research team.
监管审查
个案审查
In the United States, the Food and Drug 政府 (FDA) is charged with the governance, oversight, and regulation of clinical trial conduct and public health protection. The agency’s regulations and guidance aim to promote safe and effective development and approval of medical drugs, biologics, and devices. A key component of these goals surrounds the approval processes for investigational drugs and devices. Investigational drugs and investigational devices are approved for experimental use by the FDA under 21 CFR 312 (Investigational New Drug Application) or 21 CFR 812 (Investigational Device Exemptions).
Below outlines current FDA regulations governing human subject protection and the conduct of clinical trials:
药物或设备
药物或生物制剂
设备
A sponsor-investigator is an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug or device is administered or dispensed. Sponsor investigators are responsible for satisfying the regulatory requirements of both an investigator and a sponsor.
如何选择研究进行研究完整性和安全性审查？
RIS监测服务将优先考虑具有高风险特征的研究。 没有独立监督的印度理工学院将得到最高优先考虑。 Other studies that may be prioritized include studies where investigators hold the IND/IDE, phase I clinical trials, high enrolling clinical trials, multi-site clinical trials, studies with vulnerable populations, and federally funded studies without external monitoring. RIS Monitoring is applicable to all human research studies conducted at 奥古斯塔大学 but is not required to include all studies meeting criteria for possible review.
研究者将从研究诚信与安全审查中获得什么？
RIS reviews aim is to build a robust network of institutional and investigational compliance. RIS monitor(s) apply a regulatory and compliance perspective during these reviews creating an environment for increased knowledge and understanding of applicable human subjects research regulations and 奥古斯塔大学 policies.
研究者应该如何为研究诚信与安全审查做准备？
RIS监督员将联系首席研究员（PI）安排RIS审查。 项目负责人应尽一切努力安排审查并及时作出答复。 After the review has been scheduled, the PI will be notified of the necessary review preparations. 简而言之，需要收集研究记录以供审查。 For remote reviews, RIS monitor(s) will need to be able to access required documents. For in-person reviews, the PI/study team will need to reserve a quiet space for the review to occur.
研究者对研究诚信与安全审查的期望是什么？
The scope of RIS reviews may vary and will be tailored to the scope, nature, and complexity of the research studies being reviewed. A study representative should be available to respond in a timely manner during the review. A close-out meeting will be held to discuss any findings and the PI will receive a copy of the final report. The PI is responsible for correcting any identified items and submitting the appropriate notifications of protocol deviations or violations to the IRB of record. Please note: RIS review is not intended to be comprehensive for all subjects and all items, and it does not replace standard quality assurance reviews by the PI and their research team.
研究诚信与安全监控服务是IRB的一部分吗？
不可以，RIS监察服务是独立于审核委员会的。 This program is complimentary to and does not replace the essential roles of the IRB of record for your study, or AU’s Human 研究 Protection Program. The Monitoring Service is designed to provide early-intervention and proactive monitoring for human subjects research at Augusta University.