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 Trulance (Plecanatide )s ubmitted by Synergy Pharmaceuticals. Two pivotal studies were submitted. Six sites, the CRO and the sponsor were selected for inspection. Site inspections ranged over four to fourteen days. The CRO inspection lasted 2 days and the Sponsor inspection lasted 4 days. Two sites received FDA Form 483s.
Dr. Valor was cited for failing to follow the investigational plan, specifically:
- Eligibility violations for nine out of twenty one subjects (prohibited conmeds during pretreatment period, three subjects randomized despite exclusionary data recorded in the electronic patient diary, rescue medication taken during pretreatment period)
- Seven subjects did not have post dose ECGs as required by protocol
- Missing patient questionnaires at some study visits
Dr Koltun was cited for:
- Failing to document the number of tablets per kit returned to the sponsor at the end of the study