Recipient: John Marcum M.D. – Childrens Hospital Los Angeles
Product: Investigational device
Date: 1/27/05
Records relating to correspondence with the IRB and sponsor, including required reports, are not all complete. For instance, there is no correspondence demonstrating that the sponsor and IRB were notified of all adverse events and serious adverse events, including the nine infections and four deaths. The sponsor and IRB were not notified of the decision to deviate from or modify the approved protocol. For example, the data was not collected per protocol and the number of subjects was modified. It was also noted in the inspection report that the actual protocol version used for the conduct of the study (dated 10/02/03) was the version that was last submitted and not the version approved and returned by the IRB. This version was an electronic copy maintained in the computer and was not printed, copied and distributed to all participating clinical investigators. In your response, you have stated that the sponsor and IRB will be notified and correspondence documented; we find these responses acceptable.
Records of each subject’s case history are not all accurate. Specifically, several Case Report Forms had data times and results which did not match raw data time and results, particularly for the _____. The FDA investigators noted the Case Report Forms in general were incomplete with various cross-outs and changes by multiple authors, and an occassional white-out. In addition, one informed consent form was noted to be missing _____. In your response you included a copy of corrected data records and you state that system problems with the computerized medical record are being addressed, that copies of all raw data will be made and/or attached to the Case Report Form, and that a time range will be provided if there will is a variation in the timing of data collection. We find these responses acceptable.
Issuer: Center for Devices and Radiological Health (CDRH)
