The FDA’s inspection from September and October 2012 found that the researcher -- Jose Joseph-Vempilly, M.D., an associate professor at the University of California, San Francisco-Fresno, with a specialty in pulmonary and critical care -- failed to provide documentation of corrective actions after acknowledging that data for vital signs were entered into case report forms when such data had not been collected.
The falsified data included participants’ blood pressure, pulse rate and body temperature readings that were required to be taken at every visit during the study, according to the FDA.
“In addition, your response is inadequate because you have only referenced actions that your department is taking, and you have failed to include any corrective actions that you, as a clinical investigator, are implementing to prevent similar violations in the future,” Thomas N. Moreno, acting office director in the Office of Scientific Investigations, wrote in the letter.
The FDA also cited Dr. Joseph-Vempilly for failing to ensure that his clinical studies were conducted in accordance with the investigational plan. He was cited for enrolling subjects that did not meet the eligibility criteria of the study and failing to discontinue prohibited medications as required by the study protocol.
After receiving an FDA Form 483 in October, 2012, outlining the violations, Dr. Joseph-Vempilly responded with a corrective action plan that noted:
- The research coordinator who falsified data was terminated;
- All investigators and staff must attest that they have read and will adhere to the department’s SOPs (Standard Operation Procedures) when conducting research;
- The department will conduct comprehensive standardized training and competency validation for all new research coordinators;
- The Department of Medicine research manager and staff will perform continuous internal monitoring of studies;
- Study-specific enrollment criteria for all studies will be reviewed at weekly department research meetings, and investigators will be required to sign eligibility checklists; and
- Research teams will be required to obtain mandatory continuing education.
In addition, Dr. Joseph-Vempilly reported the findings of falsified data to the sponsor and IRB (institutional review board), and contacted all other subjects to inquire about the performance of vital sign measurements.
But due to his failure to provide “documentation of the corrective actions that you have implemented” or to “include any corrective actions that you, as a clinical investigator, are implementing to prevent similar violations in the future,” the FDA sent the warning letter.
Neither Dr. Joseph-Vempilly nor anyone from his department responded to a request for comment by press time.