How frequent are FDA 483 observations involving clinical investigators’ paper record controls?

As in other pharma operations (GMP comes to mind), clinical investigators must adhere to data integrity practices. Data integrity issues in the course of clinical trials have resulted in delayed approval of products, in addition to negative media attention. 

Paper record controls are one data integrity area of concern when it comes to clinical trials. 

Using Redica, we can pull 483 primary observations involving paper record controls issued to clinical investigators over a period of time, in this case, 2012-2022. 

So, how many 483s were issued? Redica shows 21 issued over the previous ten years.

Paper Record Controls
Redica Systems Enforcement Analytics | Paper Record Control 483 Observations

In general, Redica Systems data show that data integrity 483 observations appeared in more than half of the observations issued to clinical trial investigators of human drug clinical studies in the past 20 years. The top categories of data integrity deficiencies fall into three categories:

  • Issues with the original data
  • Data is not attributable
  • Data was not accurate

For more information on how our GCP Expert Model provides a window into clinical investigator data integrity trends, we recommend viewing the recording of the webinar, “FDA GCP Inspection Trends Identified Using AI,” featuring a prerecorded presentation by Redica Systems Senior GMP Quality Expert Jerry Chapman.

GCP Inspection Preparation

Redica’s actionable intelligence can help you stay on top of inspection preparation. Here is how our GCP Expert Model can help you:

Vendor Quality—Intelligence to identify and control risk with your critical GCP vendors

Inspection Preparation—Access deeper intelligence about inspection trends and inspector tendencies

Contact us today for a demonstration of our GCP Expert Model. 

Additional Resources

Data Integrity and Your Clinical Investigator: What the Data Shows

The Components of “Responsibilities of the Investigator” Observations

Extracting Specific Protocol Violations from Warning Letter Citations

Data Integrity Concerns Discovered in Gene Therapy Product Submissions

Webinar – FDA GCP Inspection Trends Identified Using AI