Recently, when discussing Institutional Review Board (IRB) adverse event reporting, a Project Manager for a leading medical device Contract Research Organization (CRO) brought up a valuable question regarding reporting compliance- whose job is it to ensure an investigator is compliant with IRB reporting policies?
According to ICH GCP E6 5.1.1, the sponsor is responsible for implementing and maintaining quality assurance and quality control systems to ensure that trials are conducted and reported in compliance with the protocol, Good Clinical Practice (GCP) and the applicable regulatory requirements.
The sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but is ultimately responsible for the quality and integrity of the data. The CRO should implement quality assurance and quality control (ICH GCP E6 5.2.1).
In 21 CFR 812.46, it is the sponsor’s responsibility to secure compliance when it is noted that a investigator is not complying with the signed agreement, investigational plan, or any conditions of approval imposed by the reviewing IRB.
IMARC Research, Inc. uses the FAIR Shake technique as the CRO delegated by the sponsor to ensure that the research site is in compliance with:
- Federal Regulations
- Agreements with the sponsor
- Investigational Plan
- Requirements of the IRB
IMARC monitors review a site’s IRB adverse event and non-compliance reporting policies and work with the site to ensure IRB reporting compliance.
Whose job do you think it is to make sure that the site is following its IRB’s policies? The sponsor? The CRO? The PI? The coordinator? The IRB? Explain your thoughts below.
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