FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the clinical inspection summary for Portrazza (necitumumab) submitted by Eli Lilly. Three clinical sites were chosen for inspection based on enrollment of large numbers of study subjects, and significant study drug primary efficacy results and general safety reports pertinent to decision making. Each site inspection lasted four days. The study sponsor was also inspected over the course of eight days. One site received a 483.
Dr. Ciuleanu received a 483 for:
- Failing to follow the investigational plan
- Enrolling one subject with an exclusionary clinical laboratory value
- Failing to report two serious adverse events (SAEs) within protocol specified timelines. FDA notes that the clinical investigator indicated that one of the reports was completed on time, but was not received by the sponsor.
- Failing to provide SAE follow up information within protocol specified timelines. FDA notes that the clinical investigator noted that sponsor requests for follow up information were sent to an incorrect email for a subinvestigator.
- Two lab reports did not contain all protocol required analytes on them. FDA notes that these two protocol deviations were noted during the course of routine study monitoring.
- Financial disclosure forms were not collected from two subinvestigators prior to study start.
- Inadequate investigational product accountability
- Investigational Product Accountability logs did not include records of destruction of unused investigational product accountability.