Tennessee PI Warned by FDA for Oversight Issues
Failure to adequately oversee trial operations has netted a principal investigator (PI) at Jackson, Tenn., Physicians Quality Care an FDA warning letter after the agency deemed insufficient her response to a December 2022 483.
Melanie Hoppers, who also serves as the site’s chief medical officer, was cited on the 483 for allowing participants to be enrolled in a trial and receive the study drug without a required laboratory-confirmed test result. The letter, which redacts details about the trial and trial drug, shares six instances of this failure but notes the violations are not limited to those examples.
Hoppers’ written response to the 483 details actions taken to correct the problem – including a new quality management system, SOPs and staff training – but the warning letter takes issue with the fact that the PI attributed responsibility for the errors and for correcting them to other parties.
“We emphasize that as the clinical investigator, you were ultimately responsible to ensure that your clinical study was conducted properly and in compliance with FDA regulations, both to protect the rights, safety, and welfare of study subjects and to ensure the integrity of study data,” the agency said.
In the agency’s view, Hoppers didn’t give enough information on how she, as the PI, would ensure study staff are properly supervised and overseen while carrying out assigned study procedures and tasks, such as verifying protocol requirements are adhered to, and how she would prevent similar issues from occurring going forward.
“Your failure to ensure that subjects met protocol-required inclusion criteria, and your lack of oversight and supervision of the clinical study, raise significant concerns about the safety of study subjects enrolled at your site, and about the integrity of the data generated at your site,” the FDA said.
In addition, the agency noted that her Responsibilities of the Principal Investigator SOP doesn’t list participant eligibility determinations as a task to be handled by the PI. Similarly, the SOPs describing the creation and upkeep of source documentation and management of trial regulatory files do not include the PI as a responsible party.
The FDA requested documentation of additional SOPs and processes developed by Hoppers as well as proof of staff training. The agency also requested an explanation of how the additional SOPs, internal processes and training sessions will lead to future compliance.
Read the full warning letter here.