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FDA’s Updated Monitoring Guidance has Arrived October 3, 2011

Posted by Michael Hamrell in Regulatory Thoughts.

The FDA recently published the new Draft Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring , was released in August 2011 for industry comment. The comment period ends in November 2011.

This guidance document is designed to help industry develop a proper monitoring plan to assure quality and reliable data during the conduct of clinical studies. Monitoring of a clinical study is required by regulation in 312.50 and 812.40, but the regulations do not describe what this means, how often and what steps are involved. This has always been part of industry practice and will vary from company to company. FDA also expects ‘adequate oversight’ of a clinical trial but also never defined what is adequate. Adequate monitoring has always been the issue for the proper conduct and oversight of clinical trials. What has happened over the years is that companies chose to interpret this to mean, lots of visits and 100% SDV is the only way to be adequate. However, if this were truly working, there would be no warning letters to PIs for study conduct issues, Right??

There are companies who have chosen to take a risk based approach for years and focus on the important stuff and have had acceptable studies for FDA, based on lack of audit findings. So clearly this approach can work. What I think we are seeing is FDA acknowledging that the old way is not the only way, and the use of existing (and future) technology can enhance monitoring to improve oversight and quality. Remember in 1988 when the original guidance was issued, there was no email, no internet, no eCRF, cell phones were almost nonexistent and smart phones were those wired devices on your desk where you had buttons to answer more than one line and place a call on hold. The greatest ‘e-technology’ we had at that time was the Fax machine.

So, I do not see it eliminating on-site visits, as many others have also pointed out and concurred. What I think this operationalizes and supports, is the role of centralized review of data along with on-site visits to enhance quality. CRAs will still need to make on-site visits, but they can spend less time focusing on some issues, like data consistency that can easily be checked by a computer, and focus on items that need a close live eye view to verify, like ICF forms, visit dates, or AEs not reported etc. No eCRF system and this risk based approach, can detect something if it is not captured and reported.

The other important aspect of this new draft guidance is that it again reflects FDA’s general approach in recent years to risk based approach to quality in a number of areas. This includes manufacturing quality, safety reporting and even FDA’s own inspection planning in CDER is moving to a risk based approach.



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