Clinical investigators are arguably the most critical part of clinical research at the site. The Code of Federal Regulations place a heavy burden on their shoulders, but one that can be shared and delegated a trusted study team. In the unfortunate situation where a Clinical Investigator is disqualified by the FDA certain rules exist to protect patients and ensure data integrity.
The FDA announced the proposed amendment of the regulations to expand the scope of clinical investigator disqualification. Under the current rules, “when an investigator is disqualified by a Commissioner's decision under one part of the former regulations a clinical investigator continued to be eligible to receive other types of test articles and conduct clinical investigations studying those other test articles.” In other words, when an investigator is noncompliant and the agency disqualifies them from that product research (devices) the current rules allow them to conduct trials on another type of investigational product (drugs).
Some key comments directly from the proposed rule also include:
- The interpretations of the terms “repeatedly” and “deliberately” in FDA's regulations governing disqualification of clinical investigators: 77 FR 25354
- The term “repeatedly” means, simply, more than once. A violation occurs “repeatedly” if it happens more than once.
- The term “deliberately” includes conduct that is “willful” as well as conduct demonstrating reckless disregard.
- FDA does not place limits on how far back FDA will investigate to find those applications and submissions that may be affected by a disqualified investigator who conducted trials with FDA-regulated test articles. 77 FR 25355
- FDA agrees that sponsors should be informed promptly about the disqualification of a clinical investigator. Indeed, FDA informs sponsors at several stages of the disqualification process. 77 FR 25355
• Because each situation is different, FDA evaluates on a case-by-case basis the best course of action for handling a disqualified clinical investigator's data in applications and submissions. For this reason, FDA does not intend to issue guidance to address how a disqualified investigator's data should be handled. 77 FR 25356
The goal is for this amendment to “help protect the safety and subjects involved in FDA-regulated investigations, and helps to ensure the reliability and integrity of the data used to support marketing of products regulated by FDA.”
What do you think about the changes to Clinical Investigator disqualifications? Do you agree with the new restrictions? Or would you suggest further modifications?
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