FDA inspections at clinical trial sites can cause concern if you’re ill-equipped and not prepared. Various reasons may lead to an FDA inspection. However, it’s essential to understand the reasons and adopt a preventative approach to ensure that your site is safe and secure.
One thing you could do is to adopt modern means of technology that eliminate human error and automates processes. By eliminating the occurrences of errors, you automatically minimize the chances of an FDA inspection. Data authenticity can lead to FDA inspections. Therefore, it is essential to invest in robust clinical trial data management software that can help you streamline processes and ensure the authenticity of data collected.
When operating a clinical trial, you need to be aware of the factors that can lead to an inspection. Let’s look at some common factors that can trigger an FDA inspection at your clinical trial site.
Data Integrity and Validity
Data integrity and validity are among the most common causes of an FDA inspection. The officials at FDA might want to look at the data being collected at your trial to ensure its accuracy if they feel that the results are biased and lead to a skewed conclusion. If there are discrepancies between the sponsor and information available to the FDA, they will want to visit you.
Any protocol deviations and using inadequate validation methods can also trigger an FDA inspection. If you provide inconsistent or conflicting information in the submission, there is an increased likelihood of facing an FDA inspection.
You can avoid data integrity and validity issues by investing in a robust clinical trial data management solution that ensures the efficacy, feasibility, and integrity of the data collected electronically. Check out the solutions provided by ClinicalPURSUIT, the best in the business!
Inadequate Documentation
Another trigger that may cause an FDA inspection is when you have inadequate documentation that determines the efficacy of the study. Mismanagement and manual document handling can result in the loss of essential paperwork that can be detrimental to the clinical trial.
If the FDA feels that the study isn’t being supported by thorough documentation, they might ask questions. Investing in a quality clinical trial EDC system will ensure that all documentation and paperwork are stored electronically and are available when required.
Prior History
If your site has a previous adverse history of breaking the rules and being inspected, then the likelihood of being inspected again. If the previous visit raised questions on data integrity, then the FDA officials may want to recheck the trial to ensure that the data being collected is authentic and accurate.
The core problem revolves around implementing quality EDC systems that can minimize data integrity issues. If you’re looking for quality EDC clinical trial data management software, then don’t look further than ClinicalPURSUIT. Our software makes data management and processing for clinical trials efficient, effective, and rapid. Reach out to
us directly for more information on our EDC software for clinical trials!
