Stroup fails to follow investigational plan, notes 3-item 483.

Steven Stroup, M.D., Nashville, TN, District, received a three-item 483 because his investigation did not conform with the requirements of the investigational plan.

Investigator Donna Gallien from the Nashville, TN, District Office conducted the audit.

The EIR stated that the clinical researcher did not follow the protocol in that an HIV-positive subject was given hyperthermia treatments in areas of the body that were not in the protocol.

The same violation also noted in the 483 that Stroup did not have informed consent on file for several study subjects.

The EIR added that he did not maintain on file "adequate documentation to the sponsor regarding the status of the study." For example, there was no documentation on file between the investigational site and the sponsor regarding the status of the clinical trial in 2005.

Also, "there is minimal documentation on file between the investigational site and the sponsor regarding the status of the clinical trial in 2004. Only two documents of correspondence were on file in the study binder," the 483 stated.

Another protocol violation was failure to have documented all of the training received by personnel, the EIR noted.

The next observation in the 483 was "not all changes in research activities were approved by an IRB prior to implementation."

Specifically, the doctor failed to document IRB notification regarding the protocol violation of the inclusion of an incarcerated study subject into a clinical trial.

He also failed to document IRB notification regarding the protocol violation of inclusion of an HIV study subject into a clinical trial.

Stroup stated in his response that he was aware of the patient's HIV status, but he did not know this made him ineligible.

He also noted in response that he was required to submit continuing review reports every six months. He reported at each review that there were no unexplained or serious adverse events, subject complaints or changes to the risk/benefit ratio.

"I now recognize that I had not collected sufficient data to provide the IRB accurate information on these statements ... .and did not equip the IRB with the information it needed to adequately oversee the trial."

Next, FDA documents reported that the researcher did not prepare and maintain accurate case histories.

For example, FDA said he failed to complete, date and document patient eligibility screening checklists and pretreatment evaluations. Other violations under this observation included failure to document tumor volume, physician signature, patient age and form completion date.

The doctor's written response stated: "After reviewing the report ... I conclude that the concerns raised in the 483 are valid and need to be addressed."

He stated that he did not provide "sufficient oversight to ensure that all participating investigators ... and staff members complied with the protocol."

Stroup noted that he would engage an independent consultant to perform a complete review of the trial and of all research activities underway at his practice. Steven Stroup, M.D., Nashville, TN, 1/04-31/07, Doc. 115380, $20 plus retrieval.

Steven Stroup, M.D., Nashville, TN, Nashville, TN, District

Print Get the Mag Weekly Updates