Janet K Tillisch, MD – FDA Warning Letter, Apr 9, 2013

This FDA Warning Letter, issued to Janet K. Tillisch, M.D. on June 20, 2013, details violations found during an inspection concluding April 9, 2013, concerning clinical studies (b)(4) and (b)(4). The inspection, under the Bioresearch Monitoring Program, identified failures to comply with 21 CFR Part 312.

Dr. Tillisch failed to fulfill general investigator responsibilities (21 CFR § 312.60 and Part 50), specifically by inadequately supervising delegated tasks to Site Management Organization (SMO) (b)(4). This included not having access to electronic diaries (e-diaries) for prompt adverse event review, placing subjects at risk. The letter requests clarification on e-diary access.

Violations also include failure to ensure investigations were conducted according to the investigational plan and regulations (21 CFR § 312.60). Specifically, adverse events recorded in e-diaries were not reported in CRFs for Study (b)(4), and reasons for subject withdrawal were not recorded for two subjects in Study (b)(4).

Furthermore, Dr. Tillisch failed to maintain adequate and accurate case histories (21 CFR § 312.62(b)), with multiple incomplete or missing CRFs and other recordkeeping deficiencies across both studies. Some CRFs also contained incorrect headers. Dr.