FDA EIR - John L. Berk, M.D. - June 21, 2018

An FDA inspection of Clinical Investigator John L. Berk, M.D., located in Boston, MA, was conducted from July 19-22, 2021. This first-time inspection aimed to assess compliance with applicable regulations and the overall protocol for ALN-TTRSC02 (HELIOS-A), a Phase 3 global study evaluating an investigational drug for hereditary transthyretin amyloidosis, in support of a New Drug Application. The inspection was carried out under the regulatory framework of CPG 7348.810, which pertains to Clinical Investigators.

Key issues identified during the inspection included inaccurate records for the 10-Meter Walk Tests for several subjects, where electronic data did not match source documentation. Additionally, an unreported protocol deviation was found, concerning a subject who received a prohibited concomitant drug. Inspectors also highlighted the necessity for proper labeling, identification, and calibration of all tools and instruments used to collect primary efficacy data, such as measurement tapes and stopwatches.

In response to these findings, Dr. Berk and the Clinical Research Coordinator acknowledged the observations and committed to corrective actions. These included updating the inaccurate 10-Meter Walk Test documentation, officially reporting the identified protocol deviation, and ensuring all study instruments are properly labeled, identified, and calibrated. The Clinical Research Coordinator promptly initiated corrections with data management for the affected subject records.