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Audit of Medical College of Georgia Clinical Research Procedures Completed

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Atlanta — March 7, 1997

A Board of Regents-initiated audit of clinical research procedures at the Medical College of Georgia (MCG) has been completed. The audit concluded that internal control measures for tracking clinical trials must be tightened.

The audit supports the Medical College’s initiative to further strengthen oversight of clinical research by establishing the Office of Clinical Trials Compliance which will provide an independent review of research activities conducted by MCG employees and will assure compliance of all clinical trials, provide a system for tracking clinical trials, protect research subjects and the interests of MCG. One key element will be a new monitoring process that will allow MCG officials to keep track of the reporting process between the researcher conducting clinical trials and the sponsoring company.

“This audit confirms our belief that the Medical College’s proposal will fundamentally strengthen the ability of institutional officials to provide proper oversight of clinical research,” said University System Chancellor Stephen Portch. The audit findings concluded that current procedures allow “a significant number of contracts to be negotiated and signed by representatives of private companies, the Medical College of Georgia Research Institute (MCGRI) and MCG with no provision for tracking in place to assure that research projects are being conducted in compliance with established protocols established, that federal and state regulations are being followed or that all funds are being properly received.”

The Medical College of Georgia Research Institute acts as the prime contractor with sponsor companies and subcontracts with MCG to provide the research effort.

While agreeing with the Medical College’s proposals, the Board of Regents audit resulted in additional recommendations to strengthen and increase oversight and tracking efforts.

These recommendations include: MCGRI should establish accounts receivable for all amounts due from sponsors to maintain control over these transactions; MCGRI should add a clause to MCG’s standard contract that states “any payments made to any entity other than MCGRI will not satisfy the company’s obligations under the contract;” and MCGRI should add a clause to the standard contract that informs companies of the existence of the new Office of Clinical Trials Compliance and of its oversight and compliance responsibilities for all MCG clinical studies.

“These additional recommendations will give an additional measure of assurance that future contracts are clearly identified and followed and all parties understand their respective obligations,” Porch said.

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