miscalculation

FDA Clinical Inspection Summary: Jevtana kit (Carbazitaxel) submitted by Sanofi

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or clinical investigators this week. From the archives, here is the Clinical Inspection Summary for Jevtana kit (cabazitaxel) submitted by Sanofi. Four sites were selected for inspection, based on enrollment and protocol deviations. Inspections ranged over 3 to 15 days. Three sites received a FDA Form 483.

Dr. Eisenberger was cited for failing to follow the protocol and failure to maintain accurate records, specifically:

  • Failing to delay dosing based on elevated liver enzymes one time in one patient
  • Failing to obtain four protocol required tests before dosing
  • Repeatedly dosing a subject who was on a prohibited amount of a concomitant medication, and failing to report the incorrect dose on the CRF
  • Failing to properly document the correct dates of a concomitant medication on the CRF

Dr. Oudard was cited for:

  • Miscalculating a single analgesia score
  • Reporting the incorrect dose of a concomitant medication for one patient
  • Failing to have source documents to support CRF entries for Present Pain Intensity

Dr. Ozguroglu was cited for:

  • Failing to report three instances where prestudy medications were continued on trial
  • Four instances of failing to transcribe Present Pain Intensity Scores correctly
  • One instance of miscalculating the Present Pain Intensity Score