From a recent warning letter ,..
Failure to ensure proper monitoring of the investigation and failure to ensure that the investigation is conducted in accordance with the general investigational plan and protocols contained in the IND [21 CFR 312.50 and 312.56(a)].
FDA regulations require that sponsors ensure proper monitoring of clinical investigations and ensure that their clinical investigators conduct the investigations in accordance with the protocols contained in the Investigational New Drug file (IND). Our investigation found that you failed to ensure proper monitoring of Protocol (b)(4), and that you did not ensure that a clinical investigator conducted the investigation in accordance with a protocol contained in the IND. As a result of inadequate monitoring, you did not identify and correct in a timely manner a clinical investigator's failure to obtain informed consent from subjects, in accordance with FDA regulations; a clinical investigator's failure to ensure ongoing Institutional Review Board (IRB) approval of the protocol; and a clinical investigator's failure to administer the dose of investigational drug to subjects, according to their protocol-specified treatment arm.
So why did the monitor not identify these problems?
So why did the monitor not identify these problems?
Probably the monitoring SOP did not require the monitor to look at issues the FDA investigator looks at.
ReplyDeleteClinical study sponsors do not allow sufficient time for the site monitor to review all protocol compliance requirements; it's too expensive. FDA usually allows a week at a site.
ReplyDelete