21 CFR 11

FDA Clinical Inspection Summary: Alunbrig (brigantinib) submitted by Ariad

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 Alunbrig (brigantinib) submitted by Ariad. Four sites, plus the Sponsor and Contract Research Organization (CRO) responsible for the independent reads of the trial images were inspected. Site inspections ranged over 4 to 9 days, the Sponsor inspection took place over 4 days. One site and the CRO were issued FDA Form 483s.  

Dr. Kim was cited for:

  • Failing to follow the delegation of authority log. Specifically, the study coordinator assessed adverse events
  • Failing to document hand and arm pain as adverse events in one subject
  • Failing to permit FDA to copy reports. Specifically, the audit trail of the electronic medical record could not be printed

The unnamed CRO was cited for using a computer system prior to validation, specifically:

  • Implementing the software (Mint lesion) at a time when the vendor had disclosed that it was not 21 CFR 11 compliant
  • Validating the software without confirming that it complied with charter requirements for lesion measurement. (Note: images for 126 subjects were required to be reread due to errors by the software.)
  • The CRO did not comply with charter requirements for variability testing
  • Inadequate audit trails that did not capture information required by the charter for reasons items were reread.
  • Quality assurance checks for incoming images from clinical sites were not conducted in the timeframes required by the charter

FDA notes that due to the issues noted at the CRO in the inspection, the validity of the data from the CRO (the trial's primary endpoint) could not be verified