FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, let's have a look at the inspection summary for Kengreal ( cangrelor ), submitted by the Medicines Company for priority review. Five sites, four foreign and one domestic, were selected for inspection based on enrollment and efficacy results. All BIMO inspections were 3-4 days long. One site received a 483.
Dr. Shaburshivili did not receive a 483, but minor recordkeeping issues were noted in the inspection, specifically:
- One study completion page lacked a subject number
- One randomization worksheet was not signed
- One checkbox was not marked yes on one subject's end of study form
- Four subjects had inconsistencies with their date of birth information
- Several subjects had incorrect initials
- Note: A sponsor rep was present during the inspection, and answered questions about adjudication of cardiac events
Dr. Kabeishvili was inspected and did not receive a 483. FDA noted the following during the inspection:
- Three subjects had the incorrect angiograms uploaded initially, the FDA inspector noted that this was corrected during the study
- Two pairs of subject angiograms were swapped at initial upload, the FDA inspector verified that this was corrected during the course of the study
- One subject had two different dates of birth in study documentation
- One subject had incorrect initials in study documentation
- A follow up phone call visit form was not signed
Dr. Tousek was inspected, and received a 483 for:
- Failure to report adverse events to the sponsor
- Two subjects had a hemoglobin change outside protocol limits
- Five events (atrial fibrillation, hematoma, back pain, oozing and agitation) in five subjects within 48 hours of the procedure
FDA also noted the following from the inspection at Dr. Tousek's site:
- Four laboratory forms were missing required demographic information
- An incorrect date was given for one subject for the 30 day follow up visit
- The 48 hour form was not completed for one subject
- Two ineligible subjects were enrolled, and FDA notes that this was included in the sponsor's line listings
Dr. Steinwender was inspected and did not receive a 483. FDA notes that Dr. Steinwender was not the initial Principal Investigator for the trial. FDA noted the following from the inspection:
- Four subjects did not have a repeat test, as required by protocol. FDA notes that this was at the beginning of the study, and that the monitor brought this to the sites attention.
- Five subjects did not have a hematology test drawn the day after the procedure. FDA notes that this was at the beginning of the study, and that the monitor brought it to the attention of the site, and the site subsequently corrected the issue.
- One subject was missing an ECG printout
- Source records for two subjects failed to document the Plavix prescription at discharge, that was recorded in the case report form (CRF) and sponsor data listings.
Dr. Spriggs was inspected and did not receive a 483. FDA noted the following from the inspection:
- One subject was enrolled and received study drug prior to exclusionary INR results being received