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 Zepatier submitted by Merck Sharp Dohme. Six clinical sites were selected for inspection based on enrollment of subjects with a treatment effect. One of these sites had a high number of protocol deviations, one had known issues with drug storage temperatures and one had downgraded a Serious Adverse Event (SAE) to an Adverse Event (AE). Site inspections ranged from three days to one week. One site received a 483.
Dr. Ravendrhan was cited for:
- Enrolling a subject with no baseline imaging captured in the protocol required timeframe
- Enrolling a subject that did not meet protocol required timeframes for malignancy
- Enrolling a subject without having documentation of previous response to therapy as required by the protocol
- Failing to reconsent subjects in a timely manner (2-4 weeks) as required by the IRB
- Consenting two subjects to an outdated informed consent form