FDA Clinical Investigator Warning Letter

FDA posted a warning letter to a Clinical Investigator this week. Dr. Neumeister was warned for:

  • Failing to maintain adequate and accurate case histories, specifically:
    • The PI had printed the name of the subinvestigator on study worksheets to make it appear that the subinvestigator had conducted assessments
    • The subinvestigator signed off on several records as having performed the assessments that were performed by other personnel
  • Failing to perform the investigation according to the investigational plan, specifically:
    • Failure to perform the protocol specified interview to determine study eligibility for 13 of 14 enrolled subjects
    • Enrolling a subject who did not meet the criteria of not having participated in a clinical trial within the last 30 days
    • Failure to conduct a study visit required by the protocol for three subjects