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Compliance In Focus
Posted by April Savarese on Tue, May 26, 2020

Does Remote Monitoring Make You Less Prepared For An FDA BIMO Inspection?

Remote monitoring has been encouraged since 2011, but due to COVID-19, we are seeing remote monitoring of clinical trials being utilized more frequently.
Remote-monitoring-FDA-inspections

The technology to allow for remote monitoring visits has grown significantly in the past few years. These technologies can include electronic Trial Master Files (TMF), Institutional Review Board (IRB) portals, remote access to the electronic medical records (EMR), and even secure source document sharing systems.

With these technologies, monitors can gain access remotely to the same information they would be provided if they were on site. However, you might be wondering if remote monitoring has any disadvantages, particularly when it comes to FDA inspections.

Remote Monitoring Vs. On-Site Monitoring

The main difference with monitoring remotely is you miss out on the on-site face to face interaction with clinical site personnel. Those interactions may be helpful when discussing good clinical practices and when working through any study related items.

However, this can be easily addressed if the monitor is proactive to ensure the necessary clinical site personnel are available during the remote visit for a phone call or virtual meeting. That said, if remote monitoring visits can be conducted in almost the same way as on-site visits, could the use of remote monitoring visits have an impact when an FDA Bioresearch Monitoring Program (BIMO) Inspection takes place?

The FDA publishes the BIMO Compliance Programs, which provides a standard guidance for sponsors and sites to prepare for BIMO Inspections. The FDA also publishes warning letters that can be reviewed to understand the most common violations. Even with all this information available, year after year, the most common violations from BIMO inspections remain relatively consistent.

Below are three of the top trends in FDA Warning Letters, along with how remote monitoring can help minimize these findings.

The Most Common FDA Warning Letter Violations

 

1. Failure to Follow the Investigational Plan

As there tends to be a gap between enrollment and on-site monitoring visits, study noncompliance can pile up and potentially affect the study endpoints. With the use of prompt remote monitoring, deviations from the investigational plan can be identified and the appropriate corrective and preventive actions (CAPAs) can be instituted to bring the site back into compliance.

2. Failure to Adequately Maintain Case Records

As some investigational plans and IRBs have specific requirements related to the identification and reporting of adverse events, remote monitoring can help ensure subjects’ medical records are reviewed consistently for potential events. With secure remote access to the site’s EMR, a monitor can conduct chart reviews more frequently to confirm all potential adverse events have been identified for investigator review and then appropriately reported as needed. In addition, prompt reporting of adverse events ensures sponsors and sites are protecting the safety and welfare of their study subjects throughout the trial.

3. Failure to Maintain Adequate Records and Accountability

Depending on how product accountability is maintained for the study, a potential partial remote review could be conducted. The monitor may not have access to the physical products during a remote visit, but they can review shipping records, return/disposition records and/or study specific accountability logs to confirm these align with what should be on site. If deficiencies are noted during the remote review, these can be discussed with the clinical site personnel and/or the sponsor.

As you can see, remote monitoring not only provides an effective alternative to on site monitoring, but it can also offer an advantage when it comes to preparing for an FDA BIMO inspection. 

Do you think remote monitoring could be a solution to finally mitigating these common inspection findings once and for all? Do you have any additional ideas on how remote monitoring can be used to ensure your clinical trial is inspection ready?

Please let us know your thoughts in the comments below.

How to Safely Reopen Your Clinical Research Sites

Sources:

1 U.S. Department of Health and Human Services, Food and Drug Administration. (2011). Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring. (On-line). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring

2 U.S. Department of Health and Human Services, Food and Drug Administration. (2019). Bioresearch Monitoring Program (BIMO) Compliance Programs. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-program-guidance-manual-cpgm/bioresearch-monitoring-program-bimo-compliance-programs

 

Topics: Monitoring

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