Clinical Investigator Disqualification May 13, 2011
Posted by Michael Hamrell in Regulatory Thoughts.add a comment
The FDA recently proposed to revise the regulations regarding the disqualification of a clinical investigator to cover all investigational products regulated by FDA. Under the current regulations, if FDA has information that an investigator has repeatedly or deliberately failed to comply with applicable requirements for the conduct of clinical investigations, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report the FDA can initiate a disqualification proceeding against the clinical investigator. The regulations describe a process that can include a response to the allegations, a hearing (under Part 16) and a review of the documentation by a hearing officer at FDA. If the FDA determines that the clinical investigator should be disqualified, the Commissioner’s decision currently only provides for disqualification of the clinical investigator for the type of investigational product involved in the investigation. What this means is, for example, if a clinical investigator is disqualified from receiving investigational devices for study, this person would still be eligible to receive investigational drugs (or biologics) for investigation.
The April 2011 proposed regulation when finalized, would change the language in the corresponding regulation (21 CFR 312 for drugs and biologics and 21 CFR 812 for medical devices) to provide that if an investigator is to be disqualified, the individual would be disqualified from receiving any investigational product in the future, regardless of the study conducted. Due to the public availability of the list of disqualified and restricted investigators, it is unlikely that any company would use any investigator that has been disqualified by FDA, regardless of the type of investigational product. However, this change will give FDA the ability to assure that the disqualification bars the clinical investigator from receiving any investigational product. The investigator will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. Those products include drugs, biologics, devices, new animal drugs, foods, including dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.
