FDA EIR - Reckamp, Karen L. MD - November 18, 2016

An FDA inspection of Dr. Karen L. Reckamp, a clinical investigator, was conducted between November 9 and November 18, 2016, in Duarte, CA. The inspection, carried out under the Federal Food, Drug, and Cosmetic Act and CPGM Bioresearch Monitoring guidelines, focused on a Phase 2 study of the investigational drug brigatinib for non-small cell lung cancer. The primary observation during the inspection was related to informed consent. While no formal FDA 483 'Inspectional Observations' document was issued, a significant general discussion item concerned the delayed presentation of Informed Consent version 5 to study subjects. This updated version, approved on April 22, 2016, included crucial new potential side effects such as skin rash, slow heart rate, and pneumonia, but was not presented to a subject until August 2016. Dr. Reckamp acknowledged the oversight and stated that the issue had been rectified, with a commitment to ensure the most recent informed consent is available for review and signing at subsequent subject visits. Minor protocol deviations, primarily involving out-of-window visits and missing blood analyses, were also noted but were not deemed to impact primary efficacy endpoints or patient safety. The inspection confirmed Dr. Reckamp's responsibility as the principal investigator for human subject protection and study data integrity.