Clinical investigator clears FDA audit after protocol deviations noted.(Sponsor/monitors)

Issam Raad, M.D., Houston, TX, received a clean inspection from FDA because protocol deviations that had occurred earlier were corrected before the audit was performed.

The investigation was conducted by investigator Andrea Branche from the Dallas, TX, District Office.

The report stated the investigator's test article accountability ledgers were incomplete and confusing for the amount of study drug returned by the subject. However, this deficiency was fully addressed in a note to file dated Aug. 1, 2003.

The document also stated that source documents for one subject reported that he was taking a prohibited concomitant medication. The case report form (CRF) for study conduct comment listed the details, but it was not included as a protocol deviation by the sponsor.

"According to [a clinical investigator on staff], the record was taken by the intake nurse/coordinator in one of the hospital clinics. [The investigator] stated that many patients bring in all the drugs that may have been taken recently, even if they have discontinued taking them," FDA noted.

The doctor stated that he believed that this was the reason there were no dates and dosage listed in the notes.

During the audit, the researcher presented study binders and hospital charts for each subject enrolled. The FDAer compared the records sent to the agency for the audit to the information contained in the researcher's records and patient files.

"I observed the following source data for each subject: patient enrollment worksheets, physician's consultation/medical histories, histology reports serum chemistry results, patient assessments and evaluation of response, signed CRFs and EKGs," the EIR stated.

The agency noted in the document: "From our evaluation of the EIR and the documents submitted ... we conclude that, except for minor protocol deficiencies, you adhered to the applicable statutory requirements ..."

The investigator could not be reached for comment. Issam Raad, M.D., Houston, TX, 12/7-17/04, Doc. 115375, $3 plus retrieval.

Issam Raad, M.D., Houston, TX, Dallas, TX, District

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