Dr. Holub was warned for:
- Failing to supervise the investigation
- Failing to conduct the investigation according to the investigational plan, specifically:
- Failure to assign subject screening numbers in compliance with the protocol
- Failure to perform required screening assessments, including imaging
- Enrolling a subject taking a prohibited concomitant medication
- Failing to ensure that study personnel who were administering consent, dispensing study drug and determining eligibility were listed on the FDA Form 1572
- Failing to maintain adequate records of investigational product, specifically:
- Failing to distribute drug in compliance with subject randomization
- Failure to ensure proper informed consent
- Data was collected for one subject at a screening visit months before signing the IRB approved informed consent
- Data was collected for another subject at a screening visit for another trial and used for the current trial. The subject did not sign the informed consent for the current trial until two months after data collection.
- Another subject's consent form could not be located. The caregiver for the subject (this was an Alzhimer's trial) could not recall that the subject ever signed a consent.
- Failure to retain required documents
- FDA cites two missing consent forms
- Failure to retain adequate and accurate case histories
- Four missing case report forms
- One subject was misidentified on a lab report
FDA notes that Dr. Holub indicated that the deficiencies were due to clinical research coordinators; FDA notes that it was the investigator's responsibility to oversee the trial.