FDA Warning Letter: It is unclear how adding a “clinical trials link” to your site’s electronic medical record (EMR) to provide access to study information for study staff will ensure that protocol requirements will be met (ucm455217)


Ofni Systems

 
“In your January 28, 2015, written response to the violations noted in Items 1.c., 1.d., and 1.e. above, you confirmed that protocol-required laboratory tests were missed for subjects enrolled in the clinical investigations for Protocols [redacted] and [redacted]. You indicated that as a part of your corrective action plan, you have added a “clinical trials link” to your site’s electronic medical record (EMR) to provide access to study information for study staff. You further indicated that you will review with study staff the process of accessing study information and the importance of following the study calendar.

Your response is inadequate because you did not provide sufficient information to enable us to evaluate the adequacy of your corrective action plan for use in any future clinical research that you may conduct. It is unclear how adding a “clinical trials link” to your site’s EMR will ensure that protocol requirements will be met for studies conducted at your site. You did not provide any details of a corrective action plan to prevent similar violations from occurring in the future, nor have you provided sufficient details regarding your plan to implement additional measures and procedures to address the inspection findings. Without these details, we are unable to determine whether your corrective action plan appears sufficient to prevent similar violations in the future.”

View the original warning letter.


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