Recently, a clinical site received a call from an inspector on a Thursday notifying the site of a not-for-cause inspection the following Monday. This was a short gap of time between the notification and actual audit conduct. How can sites make sure they are ready if an inspector calls today?
The answer is: by beginning with the end in mind.
What does this mean for sites? Clinical study sites have to ensure their activities from the beginning of the study support a regulatory inspection. The purpose of this blog is to discuss a few strategies sites can employ to ensure they are inspection ready at all times.
Prior to the Site Initiation Visit, the site personnel likely have completed Good Clinical Practice (GCP) training, other general clinical research training, or conducted similar clinical studies in the past. While the initial training for a new study officially begins with the Site Initiation Visit, the educational and training process for conducting a clinical trial is a continuous one. The site should educate themselves on the relevant regulations (21 CFR 50, 56, 812, 312) and guidance documents (ICH E6, many others).
Knowledge is Power
Understanding the Bioresearch Monitoring Program (BIMO) inspectional guidelines provided by the FDA is a great way to become familiar with the types of questions that could be asked. In addition, the FDA specifically makes inspectional findings publically available each year through its BIMO Program. These findings provide an immense amount of information about what FDA is looking for when inspections are conducted. Sites can take this information and apply it to the studies that they are working on to evaluate and address any potential issues that may exist.
A site has to maintain regular communication with the monitor, sponsor, and any vendors working on the study. This communication pathway should be a continuous stream of information between the listed parties. Also keep in mind sites can be proactive and initiate communication when needed with the monitor, sponsor, or vendors. Sites should not hesitate to use their resources and contacts for study-related or regulation-related questions.
Additional Quality Techniques
For a site that has may have a greater probability of an inspection (being a very high enroller, for example), there are additional quality techniques that can be conducted. Additional or more frequent monitoring visits can be scheduled. The site can work with quality assurance experts to have additional training on how to conduct and manage an inspection. A formal audit of the site, by the sponsor or another vendor, is also an option.
What are some strategies to ensure a sites inspection ready at all times? We would like to hear from sites, monitors, and sponsors!
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