The Bioresearch Monitoring (BIMO) FDA inspections are an important part of the preapproval process, designed to assure the quality and integrity of study data and adequate protection of the rights and welfare of human subjects. While a BIMO inspection may feel like a pop quiz, the FDA’s goal isn’t for sponsors to fail, but to equip them to pass. By taking a proactive approach to training and preparing, study sponsors can help their site coordinators greet inspectors with confidence. Here’s a quick refresher on BIMO FDA inspections and three steps sponsors can take to prepare.
What Happens During BIMO FDA Inspections?
During BIMO FDA inspections, the inspector will review study records and ask questions about the organization of the study team, monitoring, safety reporting, data collection and more. The BIMO investigator’s role is to determine if the sponsor, contract research organization or monitor’s practices and procedures comply with regulations. They will not attempt to scientifically evaluate the study data or protocol at this time. To help research sites prepare for BIMO inspections, the FDA provides standard guidance to review, as well as BIMO Inspection Metrics detailing the most common findings by fiscal year.
3 Ways Sponsors Can Prepare For BIMO FDA Inspections
1. Be Aware of Common Findings
The FDA conducted more than 1,600 domestic and international inspections in 2018, including 175 sponsor (including sponsor/investigator) inspections. These findings are detailed in the FDA’s BIMO 2018 report. The most common findings for sponsors were:
- Failure to ensure proper monitoring
- Failure to ensure the investigation is conducted in accordance with the general investigational plan and protocol
- Failure to secure compliance or terminate an investigator’s participation
- Failure to ensure FDA/IRB investigators are informed of significant new information or significant new adverse effects
Being aware of these findings can help sponsors educate their study teams about what to look for and take additional proactive measures if necessary. The findings change little from year to year. Having clearly defined protocols with proactive monitoring strategies will go a long way toward being prepared for regulatory inspection.
2. Read The BIMO Guidance Manuals
To help sponsors and their research sites prepare for an inspection, the FDA provides guidance manuals detailing what inspectors will review.
For sponsors who want to prepare themselves and their sites, reviewing these is a good place to start — it’s like having an open book test.
3. Conduct a Trial Master File Audit Against The BIMO Checklist
A Trial Master File (TMF) tells the story of a study, documenting everything from the process for choosing sites and investigators to data analysis. Conducting a trial master file audit can help sponsors identify any gaps in documentation prior to a BIMO inspection.
A contract research organization (CRO) can assist with conducting an independent audit and may even be able to do this remotely. The CRO should follow the BIMO Guidance Manual to ensure all regulatory requirements are met in accordance with FDA expectations.
Like taxes, BIMO inspections are inevitable. However, with advanced preparation, they don’t have to cause panic or dread. Taking these steps can help sponsors and their sites answer the call with confidence.
Get the whitepaper to learn how sponsors should prepare for BIMO Inspections.