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 Idelalisib submitted by Gilead. Three sites plus the sponsor were selected for inspection. Site inspections ranged from eight days to one month and the sponsor inspection took place over one month. One site plus the sponsor received an FDA form 483.
Dr. Pagel received an FDA Form 483 for the following:
- Twelve subjects were consented using an outdated consent form without up to date risk information.
- Three serious adverse events (SAEs) were not submitted per protocol required timeframes.
- Source information was not sufficient to support that subjects were screen failures.
- Two screen fail CRFs were not completed until nearly a year after the subjects failed screening.
- Case Report Form (CRF) entries showed that one subject received investigational product at visit five, but the source documents did not reflect this.
- Two potential infusion reactions were noted in the source documents but not on the CRF.
Gilead received a FDA form 483 for the following:
- Allowing Dr. Pagel's site to enroll subjects with an outdated informed consent form, as Dr. Pagel's site had not submitted the updated consent to the IRB. Twelve subjects signed consent forms that did not contain up to date risk information.