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Bimo inspection checklist

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The document is a BIMO Site Audit Checklist for clinical trials involving human drugs, biologics, and devices. It outlines the necessary steps and documentation required to ensure compliance with regulatory standards during site audits. Key areas of focus include authority and administration, protocol adherence, informed consent processes, institutional review board (IRB) approvals, subject records, financial disclosures, test article control, record retention, and monitoring activities. The checklist serves as a comprehensive guide for auditors to evaluate the conduct of clinical studies.

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What does the Bimo stand for?

BIMO stands for Bioresearch Monitoring, a program of on-site inspection and data audits to monitor all aspects of conduct and reporting of the US Food and Drug Administration (FDA)-regulated research. The program was established in 1977 after a need was identified to audit clinical research sites.

What is a Bimo inspection?

FDAs Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections, data audits, and remote regulatory assessments designed to monitor all aspects of the conduct and reporting of FDA regulated research.

What are Bimo listings?

BIMO listings are records of the FDAs inspection results for clinical trial sites, investigators, and sponsors. These listings help track compliance trends and give stakeholders insight into regulatory trends, common compliance challenges, and the outcomes of inspections, highlighting areas that may need improvement.

What are the four types of FDA inspections?

4 types of FDA inspections Pre-approval inspections. Has your company made a submission to the FDA requesting to market a new product? Routine inspections. Compliance follow-up inspections. For cause inspections.

What is the FDA checklist?

An FDA inspection checklist, also known as an FDA audit checklist or an inspection preparedness checklist, is a valuable tool used to prepare for FDA inspections. It consists of items and areas that FDA inspectors typically look for during their visits.

bimo audit checklist

Bimo checklist template BIMO Checklist sponsor Bimo checklist pdf FDA BIMO guidance 2024 BIMO FDA guidance Bimo checklist 2022 BIMO inspection Manual FDA BIMO inspection

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What triggers a Bimo inspection?

FDA can conduct BIMO inspections at any point during a clinical study, either for cause, near the studys conclusion, or during the agencys review of a marketing application. After conducting a BIMO inspection, the FDA may give a Form 483, which lists specific findings that require correction.

What does Bimo stand for in clinical research?

The slides accessed through the links below provide annual bioresearch monitoring (BIMO) inspection metrics by fiscal year (FY). The inspectional data cover all aspects of FDAs BIMO program (i.e., clinical investigators, IRBs, sponsors, bioequivalence, and good laboratory practices) for all Centers, as applicable.

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What does the Bimo stand for?

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