1.
Assist investigators in answering questions regarding compliance issues either before or during the conduct of your clinical trial.
The code of federal regulations, ICH guidelines and state regulations can be very complex and also intimidating. We can
help you understand the regulations and their practical implications as well as foster an understanding of the role they
play in human subject protection
2.
Quality Initiative Announcement and
FAQ's
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BIDMC has developed a Post-Approval Study Assessment to assist investigators and research staff in conducting their own review
of compliance documentation, with specific attention to meeting the approval requirements of the BIDMC CCI-IRB throughout the
term of approval. There are three visit types to investigators at BIDMC who are conducting research approved by the Committee
on Clinical Investigations (CCI):
▪
Routine Site Assessment visits which are brief, educational. We
focus proactively on identifying the risks for non-compliance that compromise patient safety and data integrity while also
providing valuable recommendations for improvement.
▪
Focused Inquiry visits are brief targeted inquiry visits
focusing on a specific question or concern generated by CCI review or complaint.
▪
Site Audits are comprehensive study audits, which assess
protocol compliance, subject safety and risk, and study implementation against federal and institutional standards.
3.
Assist Investigators and the
research team prepare for an FDA audit.
We can provide useful information and assessment tools.
FDA Audit Preparation |
