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URMC / Clinical & Translational Science Institute / Stories / October 2016 / SCORE Meeting Covers How to Handle FDA Inspections of Clinical Studies

SCORE Meeting Covers How to Handle FDA Inspections of Clinical Studies

FDA graphicThis month’s meeting of the Study Coordinators Organization for Research and Education (SCORE) featured six speakers who covered various aspects of clinical trial inspections by the Food and Drug Administration (FDA). Speakers gave advice on how to prepare and shared real life experiences of FDA inspections. 

While most people recognize the FDA’s role in protecting public health by ensuring safety of drugs and devices, Joan Adamo, Ph.D., director of Regulatory Support Services at the CTSI, pointed out the other half of their mission: advancing public health by speeding innovation. To do both, the organization must strike a balance between carefully monitoring studies and inspecting the production and testing of medical products, but not unduly delaying them with over-burdensome requirements.

One of the major take-home messages from the meeting, which was facilitated by Kathleen Wessman N.R., M.P.A., R.Q.A.P.-G.C.P., C.C.R.C., director of Research Quality Improvement in the Office for Human Subject Protection, was to always be prepared. FDA inspections may be unannounced leaving you precious little time to get things in order. Gary Gagarinas, C.O.M.T., C.C.R.A., director of Clinical Trials in Ophthalmology at the Flaum Eye Institute, recommends being an expert in your study, discussing how to handle known issues prior to an inspection, and performing regular mock inspections.

“If you ever have to choose between keeping a timeline or being compliant,” Gagarinas advises, “always be compliant.”

This is part of his “pay now or play later” motto. He argues, that failing to take time to be compliant with regulations up front, may put you at risk later.

With all of that said, some last minute preparation will undoubtedly be necessary prior to an FDA visit. All study documents should be organized, up-to-date, and easily accessible when FDA inspectors would like to access and copy study records. During an inspection, Jennifer Dolan, M.S., L.M.T., C.C.R.C., associate of Research Quality Improvement in the Office for Human Subject Protection, advises, “Answer questions to the best of your ability, but stick to the facts, never guess or speculate at an answer.”

Lori Caulfield, R.N., B.S.N., C.C.R.C., senior clinical research study coordinator and Doreen Francis, R.N., C.C.R.C., project nurse, described personal experiences with FDA inspections, both good and bad. Several of the speakers throughout the meeting shared stories of receiving an FDA 483 form, which documents concerns discovered during the inspection, and assured the group that “there is life after receiving a 483”.

An excellent piece of advice was to view the 483 form as a learning experience. Respond to errors discovered in the inspection by performing a root cause analysis to better understand why and how the error occurred – and remember that “why does not equal who”. Once you have identified the root cause, develop corrective and preventative action (CAPA) plans to remedy the situation at hand and ensure future problems do not occur through proper training on the CAPA.

In the end, FDA inspections should not be a source of anxiety for study investigators and coordinators. The ultimate goal, for all parties, is to ensure clinical studies, whether they are for a new drug or a novel medical device, are safe for human participants and results to be reliable.

For more information about the meeting, contact Nancy Needler

Michael Hazard | 10/20/2016

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