Konrad Rejdak, M.D., Ph.D. — FDA Warning Letter Findings

Failure to ensure that the investigation was conducted according to the signed investigator statement, the investigational plan, and applicable regulations; failure to protect the rights, safety, and welfare of subjects under your care [21 CFR 312.60]. Section 18.2 of the protocol states: “If electronic CRFs [case report forms] are provided by the sponsor, only authorized study site personnel will record or change data on the CRFs. If data is not entered on the CRFs during…

Failure to retain records required to be maintained for a period of 2 years following the date a marketing application is approved. [21 CFR 312.62(c)] As a clinical investigator, you are required to maintain records, including case histories, medical records, and doctor’s notes pertaining to the investigation for a period of 2 years following the date a marketing application is approved for the drug indication for which it is being investigated. (b)(6) recalled having…

Failure to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational product [21 CFR 312.62(b)]. In multiple instances, subject ability assessment scores were not entered into (b)(4) tablets at the time of assessment. One of the three assessments used was the Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale. The INCAT score was…