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In clinical research, there are two major regulatory concerns: patient safety and data integrity. While there are many possible reasons for regulators to conduct an inspection during a clinical trial, most of the time, it’s to verify these two things and to ensure that the research is being conducted according to the study protocol and GCP regulations.
If your company is sponsoring a clinical trial or if it’s a CRO conducting research on behalf of a sponsor, are you ready for an inspection?
Common Clinical Trial Issues
The issues faced by sponsors and CROs during inspection vary from one clinical study to another, but here are three types of violations that have warranted FDA warning letters.
Violations Pertaining to Patients: When it comes to clinical trials, the FDA’s foremost concern is the safety of patients who participate in them. Clinical investigators are responsible for protecting the rights, safety, and welfare of subjects during a clinical trial.
A 2010 warning letter illustrates the FDA’s emphasis on patient safety. The agency cited the sponsor for its failure to monitor a clinical trial closely, which in turn resulted in a failure to detect dosing errors involving 40 subjects at multiple trial sites, including 20 subjects who exceeded the maximum dose (1).
Violations Pertaining to Inadequate or Incomplete Data Collection: In another 2010 warning letter, the FDA was concerned about a clinical investigator’s violations that affected data integrity. The FDA noted inaccurate and inadequate case histories for patients, failure to obtain informed consent from a number of subjects, and failure to promptly inform the IRB about changes in the study (2).
Violations Pertaining to TMF: FDA regulations and ICH E6 guidance call for maintenance of the Trial Master File (TMF), which contains all essential documents throughout the life of a clinical trial. It’s not only necessary to generate the required documents, it’s equally critical that the documents are accurate and reliable.
An FDA warning letter cited a clinical investigator for ineffective management of essential documents, including inadequate and inaccurate case histories, filing of duplicate records, and some documents showed discrepancies with handwritten notes (3).
Many of the violations cited above could have been mitigated with the help of an electronic clinical quality management system. Using a robust system for document management, TMF management, audit, and other clinical trial processes is a basic way for sponsors and CROs to ensure inspection readiness and consistency of quality across clinical trial sites. By maintaining your processes in a perpetual state of inspection readiness, you will be able to focus on your core mission of conducting a safe and high-quality clinical trial.
This article is based on a white paper (“FDA Inspections of Clinical Investigators: Are You Ready”) offered by MasterControl. If you’re interested in reading the white paper, you may download it below for free.
(1) FDA warning letter sent to Martin McKay, SVP, Global R&D, Pfizer, dated April 9, 2010, viewed on Sept. 9, 2013, at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm208976.htm
(2) FDA warning letter sent to Robert Deitz, dated April 4, 2010, viewed on Sept. 9, 2013, at:http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm208002.htm
(3) FDA Warning Letter sent to Linda Bosseman, dated July 19, 2011, viewed on Sept. 9, 2013, at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm264129.htm
Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.
Cindy Fazzi, a copywriter at MasterControl Inc., writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.
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