FDA EIR - David Miklos, MD - April 07, 2017

An FDA inspection was conducted at the clinical investigator site of Dr. David Miklos, MD, in Stanford, CA, from April 3 to April 7, 2017. This high-priority CDER Clinical Investigator Data Verification Inspection, conducted under Compliance Program 7348.11, focused on assessing Dr. Miklos’s conduct as Principal Investigator for a specific study protocol. The inspection included a comprehensive review of subject files, informed consent forms, data endpoints, protocol adherence, subject safety, and regulatory records.

A key discussion item identified was that six subjects signed outdated Informed Consent Form (ICF) versions (3 and 5) after initially signing version 4. Dr. Miklos clarified this was based on sponsor instruction within the protocol. His staff committed to addressing this practice with the sponsor, IRB, and management to ensure future compliance. Other minor protocol deviations, such as an incorrect drug dosage for one subject, missed respiratory rate observations, and visits outside targeted windows, were noted in subject files but did not warrant formal observations. Data verification against source documentation was largely confirmed as valid, and an adverse event, initially not listed in the report to FDA, was confirmed to have been reported to the sponsor.

Overall, study records were found to be organized, legible, and complete. Drug control, monitoring activities, and Institutional Review Board documentation were adequate. No FDA Form 483, Inspectional Observations, was issued as a result of this inspection, indicating that while discussions on consenting practices occurred, no formal regulatory actions were required at the inspection's conclusion.